RehabilitationNCT04254367
Empowering Patients to Participate in Health Care Decisions
A study testing Learn-to-Cope in people with Rehabilitation, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The study aims to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care an rehabilitation by increasing health literacy and sense of coherence, may have a causal effect on perceived health, ability and function as well as independence and… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Learn-to-Cope
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 14 Feb 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients attending primary care centers included in the study.
- Aged 18-64 years
- Health-related impaired work ability > 60 net days last 6 months
Who cannot join
- Serious mental disorder needing psychiatric specialist care
- Serious somatic disease a definite barrier to rehabilitation for a foreseeable future
- Cognitive impairment or not speaking /understanding Swedish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empowering Patients With Long-term Impaired Work Ability to Participate in Health Related Decisions
The study aims to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care an rehabilitation by increasing health literacy and sense of coherence, may have a causal effect on perceived health, ability and function as well as independence and quality of life for patients with long-term health-related disabilities and passive coping strategies.
Read the detailed description
Chronic poor health and impaired work ability entails both personal suffering and considerable social costs. Poverty, homelessness, difficulties to handle complex issues, and maltreatment may affect health outcomes in the long run. Both sense of coherence (SOC) and the ability to understand health-related information (health literacy) influences personal coping strategies and thus the motivation to participate in health care and rehabilitation, which is known to have a positive impact on health outcome. The purpose of this study is to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence, may have a causal effect on perceived health, ability and function as well as independence and quality of life for patients with long-term health-related disabilities and passive coping strategies. The study design is a cluster randomized controlled study comparing the intervention in addition to treatment as usual (TAU) with TAU. Follow-up is performed with validated questionnaires after 3, 6 and 12 months. Primary outcome is net inactivity days (net days without employment or rehabilitation) and secondary outcome variables are the number of net and gross days with sick leave during the follow-up period, sense of coherence, health literacy, health-related quality of life, confidence in own problem solving ability, work ability and work satisfaction, social function and health habits, symptoms of depression, anxiety, and exhaustion as well as pain and catastrophization. Randomization will be performed at Primary Care Center (PCC) level. Around 30 Primary Care Centers and 400 patients will be included in the study. The intervention consists of patient education with study circles meeting half a day per week for eight following weeks. The study is expected to show whether patient education in study circles aiming to increase health literacy and sense of coherence has a causal effect on perceived health, ability and function, independence and quality of life for patients with long-term health-related disabilities and passive coping strategies compared to TAU.
The research subjects will answer all questionnaires in a web based tool approved for storing research data, esMaker (Entergate AB) on their mobile phone, iPad or computer. Individual web links to the questionnaires will be distributed via e-mail. Research subject identity is replaced with individual codes in esMaker. The research assistant will be in charge of the CodeKey and responsible for distributing the web links and for reminding the research subjects to fill in the questionnaires.
- Conditions
- Rehabilitation
- Being tested
- Learn-to-Cope
- Keywords
- health literacy, sense of coherence, empowerment, patient education as topic, health-related quality of life, coping strategies, bio-psycho-social model
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learn-to-CopeBehavioural
Patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence. The study circles will meet half a day each week for eight following weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - experimental TAU + intervention | Experimental | Patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence. The study circles will meet half a day each week for eight following weeks. Receives: Behavioral: Learn-to-Cope |
| TAU - no intervention | No intervention | Treatment as usual following local routines on each primary care center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net days with sceduled activity
What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 6 months after baseline).
Measured: Change from base-line net days with scedulded activity at 6 months
Secondary outcomes (59)
Net days with sceduled activity
What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 3 months after baseline).
Measured: Change from base-line net days with scedulded activity at 3 months
Net days with sceduled activity
What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 12 months after baseline).
Measured: Change from base-line net days with scedulded activity at 12 months
Health-related quality of life
What is the effect of interactive patient education in supervised study groups on participants' health-related quality of life (measured by change in scores in EQ-5D from baseline to 3 months after baseline). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: Change from base-line scores EQ-5D at 3 months
Health-related quality of life
What is the effect of interactive patient education in supervised study groups on participants' health-related quality of life (measured by change in scores in EQ-5D from baseline to 6 months after baseline). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: Change from base-line scores EQ-5D at 6 months
Health-related quality of life
What is the effect of interactive patient education in supervised study groups on participants' health-related quality of life (measured by change in scores in EQ-5D from baseline to 12 months after baseline). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: Change from base-line scores EQ-5D at 12 months
Sense of coherence (SOC)
What is the effect of interactive patient education in supervised study groups on the participants' sense of coherence (measured by changes in scores in SOC-13 scale in Swedish9 from baseline to 3 months after baseline). Antonovsky developed the 29 item Orientation to Life Questionnaire to measure the sense of coherence, having 11 items measuring comprehensibility, 10 items measuring manageability, and 8 items measuring meaningfulness. The response alternatives are a semantic scale of 1 point to 7 points. The questionnaire yields a summed score with a range from 29 to 203. A shorter version of 13 questions of the original form was developed by Antonovsky, where the score ranges between 13 and 91 points,
Measured: Change from base-line scores SOC-13 scale at 3 months
Sense of coherence (SOC)
What is the effect of interactive patient education in supervised study groups on the participants' sense of coherence (measured by changes in scores in SOC-13 scale in Swedish9 from baseline to 6 months after baseline). Antonovsky developed the 29 item Orientation to Life Questionnaire to measure the sense of coherence, having 11 items measuring comprehensibility, 10 items measuring manageability, and 8 items measuring meaningfulness. The response alternatives are a semantic scale of 1 point to 7 points. The questionnaire yields a summed score with a range from 29 to 203. A shorter version of 13 questions of the original form was developed by Antonovsky, where the score ranges between 13 and 91 points,
Measured: Change from base-line scores SOC-13 scale at 6 months
Sense of coherence (SOC)
What is the effect of interactive patient education in supervised study groups on the participants' sense of coherence (measured by changes in scores in SOC-13 scale in Swedish9 from baseline to 12 months after baseline). Antonovsky developed the 29 item Orientation to Life Questionnaire to measure the sense of coherence, having 11 items measuring comprehensibility, 10 items measuring manageability, and 8 items measuring meaningfulness. The response alternatives are a semantic scale of 1 point to 7 points. The questionnaire yields a summed score with a range from 29 to 203. A shorter version of 13 questions of the original form was developed by Antonovsky, where the score ranges between 13 and 91 points,
Measured: Change from base-line scores SOC-13 scale at 12 months
Health literacy
What is the effect of interactive patient education in supervised study groups on participants' health literacy (measured by change in scores in HLS-EU-Q16-SE from baseline to 3 months after baseline). The instrument consists of 16 items focusing on four HL dimensions reflecting perceived ease or difficulty in an individual's ability to access/obtain health information, understand health information (not only in written form), process/appraise health information, and apply/use health information. More specifically, the 16 items include perceived skills for understanding health information, where to seek consultation and health information on prevention, early detection, and health care, health warnings, advice given by family and friends, how to seek a second opinion, and how to apply advice given by care providers. Response options include "very easy," "easy," "difficult," and "very difficult."
Measured: Change from base-line scores HLS-EU-Q16-SE scale at 3 months
Health literacy
What is the effect of interactive patient education in supervised study groups on participants' health literacy (measured by change in scores in HLS-EU-Q16-SE from baseline to 6 months after baseline). The instrument consists of 16 items focusing on four HL dimensions reflecting perceived ease or difficulty in an individual's ability to access/obtain health information, understand health information (not only in written form), process/appraise health information, and apply/use health information. More specifically, the 16 items include perceived skills for understanding health information, where to seek consultation and health information on prevention, early detection, and health care, health warnings, advice given by family and friends, how to seek a second opinion, and how to apply advice given by care providers. Response options include "very easy," "easy," "difficult," and "very difficult."
Measured: Change from base-line scores HLS-EU-Q16-SE scale at 6 months
Health literacy
What is the effect of interactive patient education in supervised study groups on participants' health literacy (measured by change in scores in HLS-EU-Q16-SE from baseline to 12 months after baseline). The instrument consists of 16 items focusing on four HL dimensions reflecting perceived ease or difficulty in an individual's ability to access/obtain health information, understand health information (not only in written form), process/appraise health information, and apply/use health information. More specifically, the 16 items include perceived skills for understanding health information, where to seek consultation and health information on prevention, early detection, and health care, health warnings, advice given by family and friends, how to seek a second opinion, and how to apply advice given by care providers. Response options include "very easy," "easy," "difficult," and "very difficult."
Measured: Change from base-line scores HLS-EU-Q16-SE scale at 12 months
General self-efficacy
What is the effect of interactive patient education in supervised study groups on participants' general self-efficacy (measured as change in scores in S-GSE from baseline to 3 months after baseline). About: This scale is a self-report measure of self-efficacy.
Items: 10 Reliability:
Internal reliability for GSE = Cronbach's alphas between .76 and .90
Validity:
The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety.
Scoring:
All questions 1 2 3 4 The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Change from base-line scores S-GSE scale at 3 months
General self-efficacy
What is the effect of interactive patient education in supervised study groups on participants' general self-efficacy (measured as change in scores in S-GSE from baseline to 6 months after baseline). About: This scale is a self-report measure of self-efficacy.
Items: 10 Reliability:
Internal reliability for GSE = Cronbach's alphas between .76 and .90
Validity:
The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety.
Scoring:
All questions 1 2 3 4 The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Change from base-line scores S-GSE scale at 6 months
General self-efficacy
What is the effect of interactive patient education in supervised study groups on participants' general self-efficacy (measured as change in scores in S-GSE from baseline to 12 months after baseline). About: This scale is a self-report measure of self-efficacy.
Items: 10 Reliability:
Internal reliability for GSE = Cronbach's alphas between .76 and .90
Validity:
The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety.
Scoring:
All questions 1 2 3 4 The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Change from base-line scores S-GSE scale at 12 months
Social function
What is the effect of interactive patient education in supervised study groups on participants' social function (measured as change in scores in the two questions used in the sub scale "Social function" of RAND-36 from baseline to 3 months after baseline). The RAND 36-Item Health Survey laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key. Note that all items are scored so that a high score defines a more favourable health state.
Measured: Change from base-line scores sub scale "Social function" of RAND-36 at 3 months
Social function
What is the effect of interactive patient education in supervised study groups on participants' social function (measured as change in scores in the two questions used in the sub scale "Social function" of RAND-36 from baseline to 6 months after baseline). The RAND 36-Item Health Survey (Version 1.0) laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given. Note that all items are scored so that a high score defines a more favourable health state. I
Measured: Change from base-line scores sub scale "Social function" of RAND-36 at 6 months
Social function
What is the effect of interactive patient education in supervised study groups on participants' social function (measured as change in scores in the two questions used in the sub scale "Social function" of RAND-36 from baseline to 12 months after baseline). The RAND 36-Item Health Survey (Version 1.0) laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given. Note that all items are scored so that a high score defines a more favourable health state.
Measured: Change from base-line scores sub scale "Social function" of RAND-36 at 12 months
Work ability
What is the effect of interactive patient education in supervised study groups on participants' work ability (measured as change in scores in WAI from baseline to 3 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).
Measured: Change from base-line scores WAI scale at 3 months
Work ability
What is the effect of interactive patient education in supervised study groups on participants' work ability (measured as change in scores in WAI from baseline to 6 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).
Measured: Change from base-line scores WAI scale at 6 months
Work ability
What is the effect of interactive patient education in supervised study groups on participants' work ability (measured as change in scores in WAI from baseline to 12 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).
Measured: Change from base-line scores WAI scale at 12 months
Job content
What is the effect of interactive patient education in supervised study groups on participants' job content (measured as change in score in Karasek Job Content Questionnaire from baseline to 3 months after baseline). Designed to measure scales assessing psychological demands, decision latitude, social support, physical demands, and job insecurity.
Measured: Change from base-line scores Karasek Job Content Questionnaire scale at 3 months
Job content
What is the effect of interactive patient education in supervised study groups on participants' job content (measured as change in score in Karasek Job Content Questionnaire from baseline to 6 months after baseline). Designed to measure scales assessing psychological demands, decision latitude, social support, physical demands, and job insecurity.
Measured: Change from base-line scores Karasek Job Content Questionnaire scale at 6 months
Job content
What is the effect of interactive patient education in supervised study groups on participants' job content (measured as change in score in Karasek Job Content Questionnaire from baseline to 12 months after baseline). Designed to measure scales assessing psychological demands, decision latitude, social support, physical demands, and job insecurity.
Measured: Change from base-line scores Karasek Job Content Questionnaire scale at 12 months
Total number of net and gross sick leave days
What is the effect of interactive patient education in supervised study groups on the total number of net and gross sick leave days during the follow-up period (measured as change in measures defined by the Swedish Social Insurance Agency from baseline to 3 months after baseline).
Measured: Change from base-line total number of net and gross sick leave days at 3 months
Total number of net and gross sick leave days
What is the effect of interactive patient education in supervised study groups on the total number of net and gross sick leave days during the follow-up period (measured as change in measures defined by the Swedish Social Insurance Agency from baseline to 6 months after baseline).
Measured: Change from base-line total number of net and gross sick leave days at 6 months
Total number of net and gross sick leave days
What is the effect of interactive patient education in supervised study groups on the total number of net and gross sick leave days during the follow-up period (measured as change in measures defined by the Swedish Social Insurance Agency from baseline to 12 months after baseline).
Measured: Change from base-line total number of net and gross sick leave days at 12 months
Physical activity
What is the effect of interactive patient education in supervised study groups on participants' level of physical activity (measured as change in time spent on physical activities during leisure time according to LTPAI from baseline to 3 months after baseline).
Measured: Change from base-line scores LTPA (level of physical activity) scale at 3 months
Physical activity
What is the effect of interactive patient education in supervised study groups on participants' level of physical activity (measured as change in time spent on physical activities during leisure time according to LTPAI from baseline to 6 months after baseline).
Measured: Change from base-line scores LTPAI (level of physical activity) scale at 6 months
Physical activity
What is the effect of interactive patient education in supervised study groups on participants' level of physical activity (measured as change in time spent on physical activities during leisure time according to LTPAI from baseline to 12 months after baseline).
Measured: Change from base-line scores LTPAI (level of physical activity) scale at 12 months
BMI
What is the effect of interactive patient education in supervised study groups on participants' Body Mass Index, BMI (measured as change in BMI from baseline to 3 months after baseline).
Measured: Change from base-line scores BMI at 3 months
BMI
What is the effect of interactive patient education in supervised study groups on participants' Body Mass Index, BMI (measured as change in BMI from baseline to 6 months after baseline).
Measured: Change from base-line scores BMI at 6 months
BMI
What is the effect of interactive patient education in supervised study groups on participants' Body Mass Index, BMI (measured as change in BMI from baseline to 12 months after baseline).
Measured: Change from base-line scores BMI at 12 months
Symptoms of depression
What is the effect of interactive patient education in supervised study groups on participants' symptoms of depression (measured as change in score in MADRS-S from baseline to 3 months after baseline).
Scale:
0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Measured: Change from base-line scores MADRS-S scale at 3 months
Symptoms of depression
What is the effect of interactive patient education in supervised study groups on participants' symptoms of depression (measured as change in score in MADRS-S from baseline to 6 months after baseline).
Scale:
0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Measured: Change from base-line scores MADRS-S scale at 6 months
Symptoms of depression
What is the effect of interactive patient education in supervised study groups on participants' symptoms of depression (measured as change in score in MADRS-S from baseline to 12 months after baseline).
Scale:
0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Measured: Change from base-line scores MADRS-S scale at 12 months
Symptoms of anxiety
What is the effect of interactive patient education in supervised study groups on participants' symptoms of anxiety (measured change in score in GAD-7 from baseline to 3 months after baseline).
Management Scores ≥10: Further assessment (including diagnostic interview and mental status examination) and/or referral to a mental health professional recommended.
Score Symptom Severity Comments 5-9 Mild Monitor 10*-14 Moderate Possible clinically significant condition >15 Severe Active treatment probably warranted
Measured: Change from base-line scores GAD-7 scale at 3 months
Symptoms of anxiety
What is the effect of interactive patient education in supervised study groups on participants' symptoms of anxiety (measured change in score in GAD-7 from baseline to 6 months after baseline).
Score Symptom Severity Comments 5-9 Mild Monitor 10*-14 Moderate Possible clinically significant condition >15 Severe Active treatment probably warranted
Measured: Change from base-line scores GAD-7 scale at 6 months
Symptoms of anxiety
What is the effect of interactive patient education in supervised study groups on participants' symptoms of anxiety (measured change in score in GAD-7 from baseline to 12 months after baseline).
Score Symptom Severity Comments 5-9 Mild Monitor 10*-14 Moderate Possible clinically significant condition >15 Severe Active treatment probably warranted
Measured: Change from base-line scores GAD-7 scale at 12 months
Symptoms of exhaustion
What is the effect of interactive patient education in supervised study groups on participants' symptoms of exhaustion (measured as change in score in KEDS from baseline to 3 months after baseline). items
9 items/symptoms Scoring 0-6/item Total 0-54
=/>19 p exhaustion
Measured: Change from base-line scores KEDS scale at 3 months
Symptoms of exhaustion
What is the effect of interactive patient education in supervised study groups on participants' symptoms of exhaustion (measured as change in score in KEDS from baseline to 6 months after baseline).
9 items/symptoms Scoring 0-6/item Total 0-54
=/>19 p exhaustion
Measured: Change from base-line scores KEDS scale at 6 months
Symptoms of exhaustion
What is the effect of interactive patient education in supervised study groups on participants' symptoms of exhaustion (measured as change in score in KEDS from baseline to 12 months after baseline).
9 items/symptoms Scoring 0-6/item Total 0-54
=/>19 p exhaustion
Measured: Change from base-line scores KEDS scale at 12 months
Pain catastrophizing
What is the effect of interactive patient education in supervised study groups on participant pain catastrophizing (measured as change in score in PCS from baseline to 3 months after baseline).
13 items Degree 0 - not at all
- - to a slight degree
- - to a moderate degree
- - to a great degree
- - all the time
Measured: Change from base-line scores pain catastrophizing scale at 3 months
Pain catastrophizing
What is the effect of interactive patient education in supervised study groups on participant pain catastrophizing (measured as change in score in PCS from baseline to 6 months after baseline).
13 items Degree 0 - not at all
- - to a slight degree
- - to a moderate degree
- - to a great degree
- - all the time
Measured: Change from base-line scores pain catastrophizing scale at 6 months
Pain catastrophizing
What is the effect of interactive patient education in supervised study groups on participant pain catastrophizing (measured as change in score in PCS from baseline to 12 months after baseline).
13 items Degree 0 - not at all
- - to a slight degree
- - to a moderate degree
- - to a great degree
- - all the time
Measured: Change from base-line scores pain catastrophizing scale at 12 months
Participant pain
What is the effect of interactive patient education in supervised study groups on participant pain (measured as change in score in OMPSQ from baseline to 3 months after baseline). A higher score indicates a higher disability. Maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability
Measured: Change from base-line scores OMPSQ scale at 3 months
Participant pain
What is the effect of interactive patient education in supervised study groups on participant pain (measured as change in score in OMPSQ from baseline to 6 months after baseline).
Maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability
Measured: Change from base-line scores OMPSQ scale at 6 months
Participant pain
What is the effect of interactive patient education in supervised study groups on participant pain (measured as change in score in OMPSQ from baseline to 12 months after baseline).
Maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability
Measured: Change from base-line scores OMPSQ scale at 12 months
Pain spreading
What is the effect of interactive patient education in supervised study groups on participant pain spreading (measured as change in number of painful body regions from baseline to 3 months after baseline). The diagram documents pain in 19 anatomic areas. Based on the distribution of the anatomic areas, we established six different body regions. Generalized linear regression was used to evaluate the association between the number of painful nonindex body regions (categorized as 0; 1-2; or 3-6) with our measures of interest. Participants reporting no body pain, low (1-2 regions) and high (≥ 3 regions).
Measured: Change from base-line scores in number of painful body regions at 3 months
Pain spreading
What is the effect of interactive patient education in supervised study groups on participant pain spreading (measured as change in number of painful body regions from baseline to 6 months after baseline). The diagram documents pain in 19 anatomic areas. Based on the distribution of the anatomic areas, we established six different body regions. Generalized linear regression was used to evaluate the association between the number of painful nonindex body regions (categorized as 0; 1-2; or 3-6) with our measures of interest. Participants reporting no body pain, low (1-2 regions) and high (≥ 3 regions).
Measured: Change from base-line scores in number of painful body regions at 6 months
Pain spreading
What is the effect of interactive patient education in supervised study groups on participant pain spreading (measured as change in number of painful body regions from baseline to 12 months after baseline). The diagram documents pain in 19 anatomic areas. Based on the distribution of the anatomic areas, we established six different body regions. Generalized linear regression was used to evaluate the association between the number of painful nonindex body regions (categorized as 0; 1-2; or 3-6) with our measures of interest. Participants reporting no body pain, low (1-2 regions) and high (≥ 3 regions).
Measured: Change from base-line scores in number of painful body regions at 12 months
Trust in own know-how
What is the effect of interactive patient education in supervised study groups on participant trust in own know-how and ability related to improving health (measured as change in score in questions about trust in own know-how and ability to improving health from baseline to 3 months after baseline).
Measured: Change from base-line scores in questions about trust in own know-how and ability to improving health at 3 months
Trust in own know-how
What is the effect of interactive patient education in supervised study groups on participant trust in own know-how and ability related to improving health (measured as change in score in questions about trust in own know-how and ability to improving health from baseline to 6 months after baseline).
Measured: Change from base-line scores in questions about trust in own know-how and ability to improving health at 6 months
Trust in own know-how
What is the effect of interactive patient education in supervised study groups on participant trust in own know-how and ability related to improving health (measured as change in score in questions about trust in own know-how and ability to improving health from baseline to 12 months after baseline).
Measured: Change from base-line scores in questions about trust in own know-how and ability to improving health at 12 months
Partners in health care
What is the effect of interactive patient education in supervised study groups on participants being informed as patients and being a partners in health care (measured as change in score in questions about informed as a patient and being a partner in health care from baseline to 3 months after baseline).
Measured: Change from base-line scores in questions about informed as a patient and being a partner in health care at 3 months
Partners in health care
What is the effect of interactive patient education in supervised study groups on participants being informed as patients and being a partners in health care (measured as change in score in questions about informed as a patient and being a partner in health care from baseline to 6 months after baseline).
Measured: Change from base-line scores in questions about informed as a patient and being a partner in health care at 6 months
Partners in health care
What is the effect of interactive patient education in supervised study groups on participants being informed as patients and being a partners in health care (measured as change in score in questions about informed as a patient and being a partner in health care from baseline to 12 months after baseline).
Measured: Change from base-line scores in questions about informed as a patient and being a partner in health care at 12 months
Visits to primary health care
What is the effect of interactive patient education in supervised study groups on participant visits to primary health care (research subjects are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 3 months. The measurement is the change in proportion of research subjects who visited the primary health care center).
Measured: Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 3 months
Visits to primary health care
What is the effect of interactive patient education in supervised study groups on participant visits to primary health care (research subjects are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 6 months. The measurement is the change in proportion of research subjects who visited the primary health care center).
Measured: Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 6 months
Visits to primary health care
What is the effect of interactive patient education in supervised study groups on participant visits to primary health care (research subjects are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 12 months. The measurement is the change in proportion of research subjects who visited the primary health care center).
Measured: Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start14 Feb 2020
- Primary completion14 Mar 2020
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a cluster randomized controlled study comparing the intervention in addition to treatment as usual (TAU) with TAU. Follow-up is performed with validated questionnaires after 3, 6 and 12 months. Primary outcome is net inactivity days (net days without employment or rehabilitation) and secondary outcome variables are the number of net and gross days with sick leave during the follow-up period, sense of coherence, health literacy, health-related quality of life, confidence in own problem solving ability, work ability and work satisfaction, social function and health habits, symptoms of depression, anxiety, and exhaustion as well as pain and catastrophization. Randomization will be performed at PCC level. Around 30 PCCs and 400 patients will be included in the study. The intervention consists of patient education with study circles meeting half a day per week for eight following weeks.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254367
- Sponsor's protocol ID
- Learn-to-Cope
- Status last verified
- Jun 2024
- First submitted
- 21 Jan 2020
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lofgren M, Nordeman L, Ariai N, Bjorkelund C, Rembeck G, Svenningsson I, Tornbom K, Hange D. Examining the characteristics of patients with long-term impaired work ability in primary health care - a cross-sectional study. Scand J Prim Health Care. 2026 Dec;44(1):2638516. doi: 10.1080/02813432.2026.2638516. Epub 2026 Mar 23.
PubMed 41866989Lofgren M, Nordeman L, Ariai N, Bjorkelund C, Rembeck G, Svenningsson I, Tornbom K, Hange D. Effect on work ability and health-related quality of life following an interactive patient education aiming to increase sense of coherence and health literacy - the LEARN-to-COPE cluster randomized trial. Scand J Prim Health Care. 2025 Dec;43(4):805-820. doi: 10.1080/02813432.2025.2507859. Epub 2025 May 22.
PubMed 40405458
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Patients With Long-term Impaired Work Ability to Participate in Health Related Decisions
- ClinicalTrials.gov ID
- NCT04254367
- Acronym / sponsor ID
- Learn-to-Cope
- Conditions
- Rehabilitation
- Keywords
- health literacy, sense of coherence, empowerment, patient education as topic, health-related quality of life, coping strategies, bio-psycho-social model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care an rehabilitation by increasing health literacy and sense of coherence, may have a causal effect on perceived health, ability and function as well as independence and quality of life for patients with long-term health-related disabilities and passive coping strategies.
Detailed description
Chronic poor health and impaired work ability entails both personal suffering and considerable social costs. Poverty, homelessness, difficulties to handle complex issues, and maltreatment may affect health outcomes in the long run. Both sense of coherence (SOC) and the ability to understand health-related information (health literacy) influences personal coping strategies and thus the motivation to participate in health care and rehabilitation, which is known to have a positive impact on health outcome. The purpose of this study is to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence, may have a causal effect on perceived health, ability and function as well as independence and quality of life for patients with long-term health-related disabilities and passive coping strategies. The study design is a cluster randomized controlled study comparing the intervention in addition to treatment as usual (TAU) with TAU. Follow-up is performed with validated questionnaires after 3, 6 and 12 months. Primary outcome is net inactivity days (net days without employment or rehabilitation) and secondary outcome variables are the number of net and gross days with sick leave during the follow-up period, sense of coherence, health literacy, health-related quality of life, confidence in own problem solving ability, work ability and work satisfaction, social function and health habits, symptoms of depression, anxiety, and exhaustion as well as pain and catastrophization. Randomization will be performed at Primary Care Center (PCC) level. Around 30 Primary Care Centers and 400 patients will be included in the study. The intervention consists of patient education with study circles meeting half a day per week for eight following weeks. The study is expected to show whether patient education in study circles aiming to increase health literacy and sense of coherence has a causal effect on perceived health, ability and function, independence and quality of life for patients with long-term health-related disabilities and passive coping strategies compared to TAU.
The research subjects will answer all questionnaires in a web based tool approved for storing research data, esMaker (Entergate AB) on their mobile phone, iPad or computer. Individual web links to the questionnaires will be distributed via e-mail. Research subject identity is replaced with individual codes in esMaker. The research assistant will be in charge of the CodeKey and responsible for distributing the web links and for reminding the research subjects to fill in the questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study design is a cluster randomized controlled study comparing the intervention in addition to treatment as usual (TAU) with TAU. Follow-up is performed with validated questionnaires after 3, 6 and 12 months. Primary outcome is net inactivity days (net days without employment or rehabilitation) and secondary outcome variables are the number of net and gross days with sick leave during the follow-up period, sense of coherence, health literacy, health-related quality of life, confidence in own problem solving ability, work ability and work satisfaction, social function and health habits, symptoms of depression, anxiety, and exhaustion as well as pain and catastrophization. Randomization will be performed at PCC level. Around 30 PCCs and 400 patients will be included in the study. The intervention consists of patient education with study circles meeting half a day per week for eight following weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention group - experimental TAU + intervention | Experimental | Behavioral: Learn-to-CopePatient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence. The study circles will meet half a day each week for eight following weeks. |
| TAU - no intervention | No intervention | –Treatment as usual following local routines on each primary care center |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients attending primary care centers included in the study.
- Aged 18-64 years
- Health-related impaired work ability > 60 net days last 6 months
Key exclusion criteria (3 listed)
- Serious mental disorder needing psychiatric specialist care
- Serious somatic disease a definite barrier to rehabilitation for a foreseeable future
- Cognitive impairment or not speaking /understanding Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learn-to-CopePatient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence. The study circles will meet half a day each week for eight following weeks. | Behavioural | Intervention group - experimental TAU + intervention |
Primary outcome
Net days with sceduled activity
Time frame: Change from base-line net days with scedulded activity at 6 months
What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 6 months after baseline).
59 secondary outcomes
Net days with sceduled activity
Time frame: Change from base-line net days with scedulded activity at 3 months
Net days with sceduled activity
Time frame: Change from base-line net days with scedulded activity at 12 months
Health-related quality of life
Time frame: Change from base-line scores EQ-5D at 3 months
Health-related quality of life
Time frame: Change from base-line scores EQ-5D at 6 months
Health-related quality of life
Time frame: Change from base-line scores EQ-5D at 12 months
Sense of coherence (SOC)
Time frame: Change from base-line scores SOC-13 scale at 3 months
Sense of coherence (SOC)
Time frame: Change from base-line scores SOC-13 scale at 6 months
Sense of coherence (SOC)
Time frame: Change from base-line scores SOC-13 scale at 12 months
Health literacy
Time frame: Change from base-line scores HLS-EU-Q16-SE scale at 3 months
Health literacy
Time frame: Change from base-line scores HLS-EU-Q16-SE scale at 6 months
Health literacy
Time frame: Change from base-line scores HLS-EU-Q16-SE scale at 12 months
General self-efficacy
Time frame: Change from base-line scores S-GSE scale at 3 months
General self-efficacy
Time frame: Change from base-line scores S-GSE scale at 6 months
General self-efficacy
Time frame: Change from base-line scores S-GSE scale at 12 months
Social function
Time frame: Change from base-line scores sub scale "Social function" of RAND-36 at 3 months
Social function
Time frame: Change from base-line scores sub scale "Social function" of RAND-36 at 6 months
Social function
Time frame: Change from base-line scores sub scale "Social function" of RAND-36 at 12 months
Work ability
Time frame: Change from base-line scores WAI scale at 3 months
Work ability
Time frame: Change from base-line scores WAI scale at 6 months
Work ability
Time frame: Change from base-line scores WAI scale at 12 months
Job content
Time frame: Change from base-line scores Karasek Job Content Questionnaire scale at 3 months
Job content
Time frame: Change from base-line scores Karasek Job Content Questionnaire scale at 6 months
Job content
Time frame: Change from base-line scores Karasek Job Content Questionnaire scale at 12 months
Total number of net and gross sick leave days
Time frame: Change from base-line total number of net and gross sick leave days at 3 months
Total number of net and gross sick leave days
Time frame: Change from base-line total number of net and gross sick leave days at 6 months
Total number of net and gross sick leave days
Time frame: Change from base-line total number of net and gross sick leave days at 12 months
Physical activity
Time frame: Change from base-line scores LTPA (level of physical activity) scale at 3 months
Physical activity
Time frame: Change from base-line scores LTPAI (level of physical activity) scale at 6 months
Physical activity
Time frame: Change from base-line scores LTPAI (level of physical activity) scale at 12 months
BMI
Time frame: Change from base-line scores BMI at 3 months
BMI
Time frame: Change from base-line scores BMI at 6 months
BMI
Time frame: Change from base-line scores BMI at 12 months
Symptoms of depression
Time frame: Change from base-line scores MADRS-S scale at 3 months
Symptoms of depression
Time frame: Change from base-line scores MADRS-S scale at 6 months
Symptoms of depression
Time frame: Change from base-line scores MADRS-S scale at 12 months
Symptoms of anxiety
Time frame: Change from base-line scores GAD-7 scale at 3 months
Symptoms of anxiety
Time frame: Change from base-line scores GAD-7 scale at 6 months
Symptoms of anxiety
Time frame: Change from base-line scores GAD-7 scale at 12 months
Symptoms of exhaustion
Time frame: Change from base-line scores KEDS scale at 3 months
Symptoms of exhaustion
Time frame: Change from base-line scores KEDS scale at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 41866989Lofgren M, Nordeman L, Ariai N, Bjorkelund C, Rembeck G, Svenningsson I, Tornbom K, Hange D. Examining the characteristics of patients with long-term impaired work ability in primary health care - a cross-sectional study. Scand J Prim Health Care. 2026 Dec;44(1):2638516. doi: 10.1080/02813432.2026.2638516. Epub 2026 Mar 23.
- Derived from this study: PubMed 40405458Lofgren M, Nordeman L, Ariai N, Bjorkelund C, Rembeck G, Svenningsson I, Tornbom K, Hange D. Effect on work ability and health-related quality of life following an interactive patient education aiming to increase sense of coherence and health literacy - the LEARN-to-COPE cluster randomized trial. Scand J Prim Health Care. 2025 Dec;43(4):805-820. doi: 10.1080/02813432.2025.2507859. Epub 2025 May 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learn-to-Cope in people with Rehabilitation, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net days with sceduled activity (time frame: Change from base-line net days with scedulded activity at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04254367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.