Health BehaviorIMB-DSMENCT02699541
The Effectiveness of Diabetes Self-Management Education Program Based on Behavioural Change Theory
A study testing Diabetes Self-Management Education in people with Health Behavior and Diabetes Mellitus, Type 2, run by University of Nottingham at 2 sites in Jordan.
Trial summary
In this study, researchers will test the effectiveness of a self-management education programme, on self-management behaviours of patients with type two diabetes. Up to 230 consenting participants will be recruited from outpatient diabetes clinics in Jordan, 230 participants will be randomised to one of two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Health Behavior, Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes Self-Management Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesJordan
- Study dates
- Apr 2016to 18 Jan 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any age from 18 to 65 years.
- Access to a telephone whether mobile phone or land line phone (cable).
- Capable to give informed consent for themselves as well as being able to communicate, read, write and understand Arabic language in order to complete self-report outcomes questionnaires and interpret the study booklet.
- Experiencing uncontrolled glycaemic level (HbA1c >8%) at the day of visiting the clinic.
Who cannot join
- Patients who suffer from any cognitive impairment or any disease condition or taking medication that affects their memory (self-reported by patient and/or companion).
- Pregnant women because they require a specific treatment intervention due to the differences in metabolic outcomes cut off points.
- Patients who anticipate they will be admitted to the hospital during study period.
- Currently attending or have attended any diabetes education program in the last 6 months.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Effectiveness of Information-Motivation-Behavioural Skills Model-based Diabetes Self-Management Education Among Patients With Type 2 Diabetes in Jordan
In this study, researchers will test the effectiveness of a self-management education programme, on self-management behaviours of patients with type two diabetes. Up to 230 consenting participants will be recruited from outpatient diabetes clinics in Jordan, 230 participants will be randomised to one of two groups. Group 1 ( 115 patients) have received the intervention, which consisted of an introductory session of tailored, face-to-face education and advice, followed by educational materials to take away, and regular telephone support at a regularity specified by the patient, over a three-month period. This intervention is based on behavioural change theory called the Information-Motivational-Behavioural skills model. Group 2 (115 patients) have received usual clinical care with no additional intervention. Researchers have assessed the effectiveness of the intervention by measuring self-care strategies (dietary habits, physical activity and managing diabetes medications), diabetes control (HbA1c), quality of life and Diabetes Self-Management Knowledge, Motivation and Self-Efficacy at 3 time points: before the intervention, at 3 months and at 6 months.
Read the detailed description
Background: Type 2 Diabetes (T2DM) is prevalent, costly to healthcare services and associated with significant mortality; over 1.5 million deaths occur directly by diabetes in low and middle-income countries (WHO,2014) and diabetes is predicted to be the seventh leading cause of death by 2030. Ajlouni et al (2008) estimated that approximately one million people in Jordan have been diagnosed with type 2 diabetes; a figure that is increasing. More than half a million Jordanians have an uncontrolled level of Glycosylated Hemoglobin (HbA1c >7.5%) due to factors such as sedentary lifestyle and poor medication management. To prevent diabetes microvascular and macro vascular complications, increased efforts and attention need to be directed towards improving glycaemic levels and improving metabolic outcomes through appropriate glycaemic management. Intensive diabetes management by anti-hyperglycaemic medications alone may improve metabolic outcomes, but may also lead to side effects for patients such as hypoglycaemia and weight gain. Patients with diabetes are strongly recommended to engage in self-management over their glucose levels and this may be best achieved through educating patients in self-management of diabetes.
Didactic interventions have shown to improve metabolic outcomes, although benefits last less than six months and are not sustained in the long term. Educational programs need to target psychological factors such as patient's confidence, to ensure self-management strategies are sustained in the long term. Barriers in diabetes self-management behaviours map on to the Information-Motivation-Behavioural skills (IMB) Model of behavioural change. The model was critically constructed based on analysing previous interventions and addressing limitations of the theories that have been used among clients with HIV risk. Chang et al (2014) systematically reviewed the IMB model-based behavioural interventions and found that effects of IMB model persisted up to 12 months in studies followed up patients for 12 months.
Aim: To examine the effects of IMB Model-based Diabetes Self-Management Educational (DSME) intervention on three self-management activities: patients' eating habits, physical activity and medications management, in patients who attend an outpatients diabetes clinics at Jordan University Hospital and Prince Hamzeh Hospital in Jordan. The hypothesis to be tested is that the IMB educational program will improve participants' behavioural outcomes in self-care at 6 months compared with control participants.
Research protocol and methods: A two group trial with randomised allocation of 230 participants on 1:1 average for both groups. Intervention group will receive the educational intervention. Control group will receive usual clinical care and referral to diabetes educational consultation if required. This intervention is an individualised DSME program based on Information-Motivation-Behavioural (IMB) skills theory. IMB behavioural change theory assumption proposes that health-related behaviour information, motivation and behavioural skills are primary determinants of promoting health behaviour. The intervention will be based on a validated DSME toolkit and will be delivered using motivational interviewing techniques through a two face-to-face session and follow-up phone calls at patients preferred frequency for a period of 3 months.
Data collection will occur at 3 time points; baseline, 3 months and 6 months. Measures will include self-management knowledge, motivation, behavioural skills, diabetes outcomes (HbA1c), blood pressure and weight. At 3 months, some participants in the intervention group will be selected using purposive sampling, to participate in a process evaluation interview.
Measurable end point/statistical power of the study: Primary outcome is diabetes self-care activities measured at 6 months using the Summary of Diabetes Self-Care Activities Scale (SDSCA) questionnaire. Statistical power of 0.8 has been used to calculate study sample.
- Conditions
- Health Behavior, Diabetes Mellitus, Type 2
- Being tested
- Diabetes Self-Management Education
- Keywords
- Diabetes Self-Management Education, Behavioural change theory, IMB model, Diabetes Type 2
- Medical subject headings
- Health Behavior, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Self-Management EducationBehavioural
This study will implement an individualized DSME program based on Information-Motivation-Behavioral (IMB) skills theory. IMB behavioral change theory assumption proposes that health-related behavior information, motivation and behavioural skills are primary determinants of promoting health behavior.
Researcher will use a previously validated educational toolkit (PRIDE) and will be delivered using motivational interviewing techniques through several sessions for each participant. Two face-to-face sessions (one at the beginning and one at the end of the 3 month period) and one phone call per week or per fortnight.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group participants will receive the educational intervention based on the Information, Motivational, Behavioral change model. Receives: Behavioral: Diabetes Self-Management Education |
| Control group | No intervention | Control group participants will receive usual care treatment and referral to diabetes educational consultation if required. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' diabetes self-Management activities: diet habits, physical activity and medications Management
The primary outcome will be diabetes self-management activities and will be measured by two scales; Summary of Diabetes self-care activities scale (SDSCA) and Medications Adherence Rating Scale (MARS) for each participant.
Both of them will assess participants' response each by units on a scale, and each participant will have a total score calculated by summing SDSCA score and MARS score.
Measured: 6 months
Secondary outcomes (7)
Participants' glycaemic level.
Glycaemic level will be measured by the (HbA1c) lab test using the percentage unit. A blood test done for each participant each visit during the usual treatment care.
Measured: 6 months
Participants' weight.
Weight will be measured by Kilogram unit using an electric digital scale. Weight is included in the usual physical examination for each participant each visit.
Measured: 6 months
Participants' blood pressure
Blood pressure will be measured by electric device using mm/hg unit. Blood pressure is included in the usual physical examination for each participant each visit.
Measured: 6 months
Participants' quality of life.
Diabetes patients' quality of life will be measured by using Audit of Diabetes Dependent Quality of Life (ADDQoL) by units on a scale score.
Measured: 6 months
Diabetes Self-Management Knowledge
Diabetes Self-Management Knowledge will be measured by using Spoken Knowledge in Low Literacy in Diabetes Scale (SKILLD) by units on a scale score.
Measured: 6 months
Diabetes Self-Management Motivation.
Diabetes Self-Management Motivation will be measured by using both Diabetes Empowerment Scale (DES) + Medical Outcomes Study Social Support Survey (MOS-SSS).
Both of them will assess participants' response each by units on a scale, and each participant will have a total score calculated by summing DES score and MOS-SSS score.
Measured: 6 months
Diabetes Self-Management Self-Efficacy.
Diabetes Self-Management Self-Efficacy will be measured by using Perceived Diabetes Self-Management Scale (PDSMS).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completion18 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly Blake, PhD, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699541
- Sponsor's protocol ID
- 14946
- Acronym
- IMB-DSME
- Status last verified
- Aug 2017
- First submitted
- 17 Feb 2016
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Information-Motivation-Behavioural Skills Model-based Diabetes Self-Management Education Among Patients With Type 2 Diabetes in Jordan
- ClinicalTrials.gov ID
- NCT02699541
- Acronym / sponsor ID
- IMB-DSME / 14946
- Conditions
- Health Behavior, Diabetes Mellitus, Type 2
- Keywords
- Diabetes Self-Management Education, Behavioural change theory, IMB model, Diabetes Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 4 Mar 2016 (estimated)
- 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.
In this study, researchers will test the effectiveness of a self-management education programme, on self-management behaviours of patients with type two diabetes. Up to 230 consenting participants will be recruited from outpatient diabetes clinics in Jordan, 230 participants will be randomised to one of two groups. Group 1 ( 115 patients) have received the intervention, which consisted of an introductory session of tailored, face-to-face education and advice, followed by educational materials to take away, and regular telephone support at a regularity specified by the patient, over a three-month period. This intervention is based on behavioural change theory called the Information-Motivational-Behavioural skills model. Group 2 (115 patients) have received usual clinical care with no additional intervention. Researchers have assessed the effectiveness of the intervention by measuring self-care strategies (dietary habits, physical activity and managing diabetes medications), diabetes control (HbA1c), quality of life and Diabetes Self-Management Knowledge, Motivation and Self-Efficacy at 3 time points: before the intervention, at 3 months and at 6 months.
Detailed description
Background: Type 2 Diabetes (T2DM) is prevalent, costly to healthcare services and associated with significant mortality; over 1.5 million deaths occur directly by diabetes in low and middle-income countries (WHO,2014) and diabetes is predicted to be the seventh leading cause of death by 2030. Ajlouni et al (2008) estimated that approximately one million people in Jordan have been diagnosed with type 2 diabetes; a figure that is increasing. More than half a million Jordanians have an uncontrolled level of Glycosylated Hemoglobin (HbA1c >7.5%) due to factors such as sedentary lifestyle and poor medication management. To prevent diabetes microvascular and macro vascular complications, increased efforts and attention need to be directed towards improving glycaemic levels and improving metabolic outcomes through appropriate glycaemic management. Intensive diabetes management by anti-hyperglycaemic medications alone may improve metabolic outcomes, but may also lead to side effects for patients such as hypoglycaemia and weight gain. Patients with diabetes are strongly recommended to engage in self-management over their glucose levels and this may be best achieved through educating patients in self-management of diabetes.
Didactic interventions have shown to improve metabolic outcomes, although benefits last less than six months and are not sustained in the long term. Educational programs need to target psychological factors such as patient's confidence, to ensure self-management strategies are sustained in the long term. Barriers in diabetes self-management behaviours map on to the Information-Motivation-Behavioural skills (IMB) Model of behavioural change. The model was critically constructed based on analysing previous interventions and addressing limitations of the theories that have been used among clients with HIV risk. Chang et al (2014) systematically reviewed the IMB model-based behavioural interventions and found that effects of IMB model persisted up to 12 months in studies followed up patients for 12 months.
Aim: To examine the effects of IMB Model-based Diabetes Self-Management Educational (DSME) intervention on three self-management activities: patients' eating habits, physical activity and medications management, in patients who attend an outpatients diabetes clinics at Jordan University Hospital and Prince Hamzeh Hospital in Jordan. The hypothesis to be tested is that the IMB educational program will improve participants' behavioural outcomes in self-care at 6 months compared with control participants.
Research protocol and methods: A two group trial with randomised allocation of 230 participants on 1:1 average for both groups. Intervention group will receive the educational intervention. Control group will receive usual clinical care and referral to diabetes educational consultation if required. This intervention is an individualised DSME program based on Information-Motivation-Behavioural (IMB) skills theory. IMB behavioural change theory assumption proposes that health-related behaviour information, motivation and behavioural skills are primary determinants of promoting health behaviour. The intervention will be based on a validated DSME toolkit and will be delivered using motivational interviewing techniques through a two face-to-face session and follow-up phone calls at patients preferred frequency for a period of 3 months.
Data collection will occur at 3 time points; baseline, 3 months and 6 months. Measures will include self-management knowledge, motivation, behavioural skills, diabetes outcomes (HbA1c), blood pressure and weight. At 3 months, some participants in the intervention group will be selected using purposive sampling, to participate in a process evaluation interview.
Measurable end point/statistical power of the study: Primary outcome is diabetes self-care activities measured at 6 months using the Summary of Diabetes Self-Care Activities Scale (SDSCA) questionnaire. Statistical power of 0.8 has been used to calculate study sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Diabetes Self-Management EducationIntervention group participants will receive the educational intervention based on the Information, Motivational, Behavioral change model. |
| Control group | No intervention | –Control group participants will receive usual care treatment and referral to diabetes educational consultation if required. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any age from 18 to 65 years.
- Access to a telephone whether mobile phone or land line phone (cable).
- Capable to give informed consent for themselves as well as being able to communicate, read, write and understand Arabic language in order to complete self-report outcomes questionnaires and interpret the study booklet.
- Experiencing uncontrolled glycaemic level (HbA1c >8%) at the day of visiting the clinic.
Key exclusion criteria (4 listed)
- Patients who suffer from any cognitive impairment or any disease condition or taking medication that affects their memory (self-reported by patient and/or companion).
- Pregnant women because they require a specific treatment intervention due to the differences in metabolic outcomes cut off points.
- Patients who anticipate they will be admitted to the hospital during study period.
- Currently attending or have attended any diabetes education program in the last 6 months.
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 |
|---|---|---|
| Diabetes Self-Management EducationThis study will implement an individualized DSME program based on Information-Motivation-Behavioral (IMB) skills theory. IMB behavioral change theory assumption proposes that health-related behavior information, motivation and behavioural skills are primary determinants of promoting health behavior. Researcher will use a previously validated educational toolkit (PRIDE) and will be delivered using motivational interviewing techniques through several sessions for each participant. Two face-to-face sessions (one at the beginning and one at the end of the 3 month period) and one phone call per week or per fortnight. | Behavioural | Intervention group |
Primary outcome
Participants' diabetes self-Management activities: diet habits, physical activity and medications Management
Time frame: 6 months
The primary outcome will be diabetes self-management activities and will be measured by two scales; Summary of Diabetes self-care activities scale (SDSCA) and Medications Adherence Rating Scale (MARS) for each participant. Both of them will assess participants' response each by units on a scale, and each participant will have a total score calculated by summing SDSCA score and MARS score.
7 secondary outcomes
Participants' glycaemic level.
Time frame: 6 months
Participants' weight.
Time frame: 6 months
Participants' blood pressure
Time frame: 6 months
Participants' quality of life.
Time frame: 6 months
Diabetes Self-Management Knowledge
Time frame: 6 months
Diabetes Self-Management Motivation.
Time frame: 6 months
Diabetes Self-Management Self-Efficacy.
Time frame: 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 15 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Holly Blake, PhD study chair
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self-Management Education in people with Health Behavior and Diabetes Mellitus, Type 2, run by University of Nottingham at 2 sites in Jordan.
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 4 inclusion and 4 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 15 Aug 2017. 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 Jordan. 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?
Participants' diabetes self-Management activities: diet habits, physical activity and medications Management (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2017.