Chronic DiseaseSEE2:0NCT06484322
Strategies Empowering Activities in Everyday Life: An Internet-based Occupational Therapy Intervention
A study testing Strategies Empowering Activities in Everyday life (SEE 2.0) in people with Chronic Disease, run by Luleå Tekniska Universitet at 2 sites in Sweden.
Trial summary
The purpose of the study is to evaluate the feasibility, potential outcomes and the implementation process of a second updated version of an internet-based intervention in occupational therapy, focusing on self-management in activities of everyday life to promote health in people with chronic diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Strategies Empowering Activities in Everyday life (SEE 2.0)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSweden
- Study dates
- 10 Sep 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with, or at risk of developing, a chronic disease/long-term condition such as long-term pain, stress-related conditions, chronic fatigue syndrome, rheumatological diseases, lung diseases, or neurological conditions.
- Age: 18-75 years
- Experiencing difficulties to have an active everyday life and/or experiencing a need to develop self-management strategies in everyday life.
- Have access to a screen/computer, internet and e-ID as well as being able to use them
- Be able to participate in the program, including be ready for a process of change
- Understanding of the Swedish language in written and oral form.
Who cannot join
- Sickness or disease which causes difficulties with understanding written and verbal advice (e.g. mental or cognitive illness).
- Having an ongoing misuse
- Receiving palliative care
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Luleå university of technology
Luleå, None Selected, 971 87
Maria, Professor, 0702827533, Maria.Larsson-Lund@ltu.se
Asa Lindback, Administrator, 0920-493806, asa.lindback@ltu.se
- Not yet recruiting
Luleå University of Technology
Luleå, 97187
Maria Larsson-Lund, Professor, 0920-49 38 33 ext. +46, maria.larsson-lund@ltu.se
Patrik Sjoeberg, Phd student, 076-126 76 85 ext. +46, Patrik.sjoberg@ltu.se
About this study
Official title: Strategies Empowering Activities in Everyday Life (SEE 2.0); A Feasibility Evaluation of an Internet-based Occupational Therapy Intervention
The purpose of the study is to evaluate the feasibility, potential outcomes and the implementation process of a second updated version of an internet-based intervention in occupational therapy, focusing on self-management in activities of everyday life to promote health in people with chronic diseases.
Read the detailed description
The number of people with chronic disease is increasing as is the need of preventive efforts to facilitate their health. Chronic diseases are defined as 'long-term health conditions' that require constant attention and/or limit activities of daily living. People living with one or multiple chronic diseases experience difficulties to live an active everyday life and restrictions of engagement in various activities are common. Interventions that support their process of change and development of self-management in everyday life in relation to their changed capacity needs to be established. Research shows that the access to interventions is facilitated by the use of internet-based solutions. Hence, an internet-based occupational therapy intervention 'Strategies Empowering activities in Everyday life' (SEE) has been developed that will be evaluated in a feasibility trial.
The feasibility study is designed as a longitudinal trial with pre-test, post test evaluation without control group embedded in a mixed method approach. Data will be collected by assessment tools, qualitative interviews and group interviews. Evaluation of the feasibility of the intervention and the study design will be conducted in terms of acceptability, adherence, values, and implementation, from the perspective of patients with chronic disease and health care personnel at different organizational levels in primary care, as well as in out-patient and in-patient care at a regional hospital.
The results from this feasibility study will support the continued development of SEE in future larger-scale evaluation studies. The goal is that SEE will add to existing interventions and becomes implemented in clinical practice. The results will be published in peer-reviewed scientific journals and presented at conferences.
- Conditions
- Chronic Disease
- Being tested
- Strategies Empowering Activities in Everyday life (SEE 2.0)
- Keywords
- Chronic disease, Self-management, Activities of daily life, Internet-based, Tele-rehabilitation, E-health, Occupational therapy, Prevention, Rehabilitation, Long-term health conditions
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategies Empowering Activities in Everyday life (SEE 2.0)Behavioural
SEEs internet-based intervention process begins with supporting the client to explore the need of and readiness for changes in everyday life. Thereafter, the client is supported to self-analyse their engagement in activities in everyday life along with use of management strategies in everyday life. Next, the client takes on web- modules including short educational movies with subsequent analyses and reflections. The modules aim to support the development of self-management by improving the knowledge of how strategies and changes in daily activities can prevent disabilities and contribute to improved health. After that, the focus is on establishing an activity plan with goals and activity-based management strategies to promote an active everyday life. The clients' implementation of the plan is supported through follow-up meetings. During the whole intervention process, the client is regularly supported by an occupational therapist through feedback and online guiding dialogues.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The group will receive the internet-based intervention 'SEE' focusing on supporting self-management of activities in everyday life to promote health. Beside SEE, they will also receive care as usual. Receives: Behavioral: Strategies Empowering Activities in Everyday life (SEE 2.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Satisfaction with Daily Occupation (SDO-13)
Measures change in satisfaction of daily occupations through a structured interview with 13 questions within areas such as work/studies, leisure, home and self-care occupations. Satisfaction with occupations is measured on an ordinal scale with a score ranging from 0-7. The total rating range between 13-91. Higher score indicates a higher satisfaction with daily occupations.
Measured: Change from baseline to four- and twelve months post-base line
Occupational Balance Questionnaire (OBQ)
Measures change in perceived occupational balance; occupational balance reflects a person's subjective perception of having the right amount of- and the right variation between activities. The OBQ consist of 11 items rated on a four-point ordinal scale, scored 0 to 3. A total score may range between 0 and 33 where a higher score implies a higher sense of occupational balance.
Measured: Change from baseline to four- and twelve months post-base line
Occupational values with pre-defined items (Oval-pd).
Measures change in occupational values which reflects the subjective perception of concrete, symbolic or self-rewarding values in activities. The Oval-pd consists of 18 items rated on a four-point ordinal scale, scored 1 to 4. The responses add up to a total score between 18-72, a higher score indicates higher occupational value in the activities of everyday life.
Measured: Change from baseline to four- and twelve months post-base line
Secondary outcomes (7)
Life satisfaction questionnaire (Lisat-11)
Measures a change in life satisfaction. Lisat-11 consists of 11 items rated on an ordinal scale scored 1-6. A higher score indicates a higher level of life satisfaction.
Measured: Change from baseline to four- and twelve months post-base line
Work ability index (WAI)
Measures a change in self-perceived work ability. Self-perceived work ability is rated on a 10-point ordinal scale and a higher score indicates higher perceived work ability.
Measured: Change from baseline to four- and twelve months post-base line
RAND-36
Measures change in perceived health and function in everyday life and consists of 36 items with an ordinal scale across 8 dimensions of health. The dimensions of health are graded on a scale 0-100 and a higher score indicates a higher perceived health and function in everyday life.
Measured: Change from baseline to four- and twelve months post-base line
General Self-Efficacy (GSE-10)
Measures change in self-reported self-efficacy which consists of 10 items on an ordinal scale from 1-4. The total score ranges from 10-40 and a higher score indicates higher self- efficacy.
Measured: Change from baseline to four- and twelve months post-base line
Mental Fatigue Scale (MFS)
Measures change in perceived mental fatigue and consists of 14 items rated on an ordinal scale (0-3). The summarized score ranges from 0-42. Scores over 10.5 indicate fatigue.
Measured: Change from baseline to four- and twelve months post-base line
EuroQol 5 Dimensions (EQ-5D) Thermometer
Measures a change in perceived health with a score ranging from 0-100. A higher score indicates better perceived health.
Measured: Change from baseline to four- and twelve months post-base line
Perceived Stress Scale (PSS)
Change in perceived stress on 10 items rated on an ordinal scale (0-4). The summarised score range from 0-40. A higher score indicates a higher level of perceived stress.
Measured: Change from baseline to four- and twelve months post-base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start10 Sep 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The feasibility study has been designed as a longitudinal pre-test, post test trial without a control group embedded in a mixed method approach. The participants will receive the internet-based occupational therapy intervention 'SEE'. Data from the participants will be collected at baseline (0) and 4- and 12 months post baseline.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luleå Tekniska Universitet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Larsson Lund, Professor, Study chair, LTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484322
- Sponsor's protocol ID
- SEE-633 940
- Acronym
- SEE2:0
- Status last verified
- Jan 2025
- First submitted
- 20 Jun 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsson-Lund M, Karlsson Sundbaum J, Mansson Lexell E, Spinord L. Feasibility study of the internet-based intervention 'Strategies for Empowering activities in Everyday life' (SEE 2.0) for use by people with chronic diseases and long-term disorders in healthcare: a study protocol. BMJ Open. 2025 Oct 21;15(10):e102026. doi: 10.1136/bmjopen-2025-102026.
PubMed 41125291
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies Empowering Activities in Everyday Life (SEE 2.0); A Feasibility Evaluation of an Internet-based Occupational Therapy Intervention
- ClinicalTrials.gov ID
- NCT06484322
- Acronym / sponsor ID
- SEE2:0 / SEE-633 940
- Conditions
- Chronic Disease
- Keywords
- Chronic disease, Self-management, Activities of daily life, Internet-based, Tele-rehabilitation, E-health, Occupational therapy, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Luleå Tekniska UniversitetUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 3 Jul 2024 (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 purpose of the study is to evaluate the feasibility, potential outcomes and the implementation process of a second updated version of an internet-based intervention in occupational therapy, focusing on self-management in activities of everyday life to promote health in people with chronic diseases.
Detailed description
The number of people with chronic disease is increasing as is the need of preventive efforts to facilitate their health. Chronic diseases are defined as 'long-term health conditions' that require constant attention and/or limit activities of daily living. People living with one or multiple chronic diseases experience difficulties to live an active everyday life and restrictions of engagement in various activities are common. Interventions that support their process of change and development of self-management in everyday life in relation to their changed capacity needs to be established. Research shows that the access to interventions is facilitated by the use of internet-based solutions. Hence, an internet-based occupational therapy intervention 'Strategies Empowering activities in Everyday life' (SEE) has been developed that will be evaluated in a feasibility trial.
The feasibility study is designed as a longitudinal trial with pre-test, post test evaluation without control group embedded in a mixed method approach. Data will be collected by assessment tools, qualitative interviews and group interviews. Evaluation of the feasibility of the intervention and the study design will be conducted in terms of acceptability, adherence, values, and implementation, from the perspective of patients with chronic disease and health care personnel at different organizational levels in primary care, as well as in out-patient and in-patient care at a regional hospital.
The results from this feasibility study will support the continued development of SEE in future larger-scale evaluation studies. The goal is that SEE will add to existing interventions and becomes implemented in clinical practice. The results will be published in peer-reviewed scientific journals and presented at conferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The feasibility study has been designed as a longitudinal pre-test, post test trial without a control group embedded in a mixed method approach. The participants will receive the internet-based occupational therapy intervention 'SEE'. Data from the participants will be collected at baseline (0) and 4- and 12 months post baseline.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Strategies Empowering Activities in Everyday life (SEE 2.0)The group will receive the internet-based intervention 'SEE' focusing on supporting self-management of activities in everyday life to promote health. Beside SEE, they will also receive care as usual. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with, or at risk of developing, a chronic disease/long-term condition such as long-term pain, stress-related conditions, chronic fatigue syndrome, rheumatological diseases, lung diseases, or neurological conditions.
- Age: 18-75 years
- Experiencing difficulties to have an active everyday life and/or experiencing a need to develop self-management strategies in everyday life.
- Have access to a screen/computer, internet and e-ID as well as being able to use them
- Be able to participate in the program, including be ready for a process of change
Key exclusion criteria (3 listed)
- Sickness or disease which causes difficulties with understanding written and verbal advice (e.g. mental or cognitive illness).
- Having an ongoing misuse
- Receiving palliative care
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 |
|---|---|---|
| Strategies Empowering Activities in Everyday life (SEE 2.0)SEEs internet-based intervention process begins with supporting the client to explore the need of and readiness for changes in everyday life. Thereafter, the client is supported to self-analyse their engagement in activities in everyday life along with use of management strategies in everyday life. Next, the client takes on web- modules including short educational movies with subsequent analyses and reflections. The modules aim to support the development of self-management by improving the knowledge of how strategies and changes in daily activities can prevent disabilities and contribute to improved health. After that, the focus is on establishing an activity plan with goals and activity-based management strategies to promote an active everyday life. The clients' implementation of the plan is supported through follow-up meetings. During the whole intervention process, the client is regularly supported by an occupational therapist through feedback and online guiding dialogues. | Behavioural | Intervention |
Primary outcome
The Satisfaction with Daily Occupation (SDO-13)
Time frame: Change from baseline to four- and twelve months post-base line
Measures change in satisfaction of daily occupations through a structured interview with 13 questions within areas such as work/studies, leisure, home and self-care occupations. Satisfaction with occupations is measured on an ordinal scale with a score ranging from 0-7. The total rating range between 13-91. Higher score indicates a higher satisfaction with daily occupations.
Occupational Balance Questionnaire (OBQ)
Time frame: Change from baseline to four- and twelve months post-base line
Measures change in perceived occupational balance; occupational balance reflects a person's subjective perception of having the right amount of- and the right variation between activities. The OBQ consist of 11 items rated on a four-point ordinal scale, scored 0 to 3. A total score may range between 0 and 33 where a higher score implies a higher sense of occupational balance.
Occupational values with pre-defined items (Oval-pd).
Time frame: Change from baseline to four- and twelve months post-base line
Measures change in occupational values which reflects the subjective perception of concrete, symbolic or self-rewarding values in activities. The Oval-pd consists of 18 items rated on a four-point ordinal scale, scored 1 to 4. The responses add up to a total score between 18-72, a higher score indicates higher occupational value in the activities of everyday life.
7 secondary outcomes
Life satisfaction questionnaire (Lisat-11)
Time frame: Change from baseline to four- and twelve months post-base line
Work ability index (WAI)
Time frame: Change from baseline to four- and twelve months post-base line
RAND-36
Time frame: Change from baseline to four- and twelve months post-base line
General Self-Efficacy (GSE-10)
Time frame: Change from baseline to four- and twelve months post-base line
Mental Fatigue Scale (MFS)
Time frame: Change from baseline to four- and twelve months post-base line
EuroQol 5 Dimensions (EQ-5D) Thermometer
Time frame: Change from baseline to four- and twelve months post-base line
Perceived Stress Scale (PSS)
Time frame: Change from baseline to four- and twelve months post-base line
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 41125291Larsson-Lund M, Karlsson Sundbaum J, Mansson Lexell E, Spinord L. Feasibility study of the internet-based intervention 'Strategies for Empowering activities in Everyday life' (SEE 2.0) for use by people with chronic diseases and long-term disorders in healthcare: a study protocol. BMJ Open. 2025 Oct 21;15(10):e102026. doi: 10.1136/bmjopen-2025-102026.
- Individual participant dataSharing planned: No
Related trials for Chronic Disease
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Maria Larsson Lund, Professor study chair
LTU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategies Empowering Activities in Everyday life (SEE 2.0) in people with Chronic Disease, run by Luleå Tekniska Universitet at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Larsson-Lund, Professor (+0046- 920-493833 ext. +46, maria.larsson-lund@ltu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Satisfaction with Daily Occupation (SDO-13) (time frame: Change from baseline to four- and twelve months post-base line). The study lists 3 primary outcomes in all. 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 NCT06484322, which also lists 1 linked publication.
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 17 Sep 2025.