Value-based Emotion-focused Educational Programme to Reduce Diabetes-related Distress

Study Overview
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Brief Summary
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The purpose of the clinical trial is to evaluate the effectiveness of a relatively simple and short value-based emotion-focused educational programme in adults with type 2 diabetes (VEMOFIT) on diabetes-related distress, depressive symptoms, illness perception, medication adherence, quality of life, diabetes self-efficacy, self-care and clinical outcomes.

Detailed Description
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Type 2 diabetes (T2D) patients experience many psychosocial problems related to their diabetes, as well as social- and work-related relationships. These often lead to emotional disorders such as distress, stress, anxiety and depression. Without proper care, these patients use more often negative coping strategies and more frequently expect that their diabetes will negatively affect their future. A cluster randomised controlled trial will be conducted in 10 public health clinics (HC) in Malaysia. These clusters are eligible if they are providing standard diabetes care according to national clinical practice guidelines, not involved in similar trial and having nurses to be trained to deliver the VEMOFIT educational programmes. Pre-stratification by cluster size and geographic areas of the HCs will get randomised five HCs to the VEMOFIT group (VG) and attention-meetings group (AG), respectively.

Official Title
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The Effectiveness of a Value-based Emotion-focused Educational Programme to Reduce Diabetes-related Distress in Malay Adults With Type 2 Diabetes (VEMOFIT): a Cluster Randomised Controlled Trial

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: VEMOFIT
* Behavioral: Attention-meetings (AG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malay patients Diagnosed with T2D for at least two years On regular follow-up with at least three visits in the past one year Have diabetes-related distress (mean DDS-17 score ≥ 3) Showing poor disease control (not reaching targets for one of the three biomarkers, namely HbA1c ≥ 8%, blood pressure ≥ 140/90 mmHg and LDL-C > 2.6 mmol/L) Exclusion Criteria: Patients who are enrolled in other clinical studies Pregnant or lactating Having psychiatric/ psychological disorders that could impair judgments and memory Patients who cannot read or understand English or Malay Patients who scored ≥ 20 on the Patient Health Questionnaire-9 (PHQ-9) that suggest a severe depression

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Attention-meetings (AG)<br>Attention-control | Behavioral: Attention-meetings (AG)<br>* Patients in the health clinics randomised to the AG, will receive the usual T2D care by the clinic doctors and education by the clinic paramedics based on the recommendations in the Malaysian clinical guidelines. At T1, T2 and T4, patients (not including their significant others) in AG will be gathered in groups of 10-12 people for the primary and secondary outcomes evaluation. This session will include general discussion on feeling about and coping with T2D, social support at home and satisfaction with treatment and care received at the respective clinics.<br>|
| Experimental: VEMOFIT (VG)<br>Personal value exploration, disease education, emotional skills and goal setting. | Behavioral: VEMOFIT<br>* The VEMOFIT intervention involves four biweekly two hours sessions over a period of about six weeks, and a booster at three months follow-up. It consists of a mixture of 1) exploring illness perceptions and personal meanings of diabetes, 2) cognition-focused education on diabetes and practical skills in self-management and 3) emotion-focused training on recognising emotions in the self and others. Each group will consist of 10 to 12 participants of equal representation by the patients and their significant others.<br>* Other names: Value-based emotion-focused educational programme;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes-related distress | Measured with the 17-item Diabetes Distress Scale (DDS-17) | 6-week (immediate post-intervention) [T1] | 
| Diabetes-related distress | Measured with the 17-item Diabetes Distress Scale (DDS-17) | 6-month [T2] | 
| Diabetes-related distress | Measured with the 17-item Diabetes Distress Scale (DDS-17) | 12-month [T3] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Measured with the Patient Health Questionnaire (PHQ-9) | 6-week (immediate post-intervention) [T1] | 
| Depression | Measured with the Patient Health Questionnaire (PHQ-9) | 6-month [T2] | 
| Depression | Measured with the Patient Health Questionnaire (PHQ-9) | 12-month [T3] | 
| Illness perception | Measured with the Brief Illness Perception Questionnaire (BIPQ) | 6-week (immediate post-intervention) [T1] | 
| Illness perception | Measured with the Brief Illness Perception Questionnaire (BIPQ) | 6-month [T2] | 
| Illness perception | Measured with the Brief Illness Perception Questionnaire (BIPQ) | 12-month [T3] | 
| Quality of life | Measured with the WHOQOL-BREF | 6-month [T2] | 
| Quality of life | Measured with the WHOQOL-BREF | 12-month [T3] | 
| Self-efficacy | Measured by the Diabetes Management Self Efficacy Scale (DMSES) | 6-week (immediate post-intervention) [T1] | 
| Self-efficacy | Measured by the Diabetes Management Self Efficacy Scale (DMSES) | 6-month [T2] | 
| Self-efficacy | Measured by the Diabetes Management Self Efficacy Scale (DMSES) | 12-month [T3] | 
| Self-care behaviours | Measured with the Diabetes Self-Care Activities (SDSCA) scale | 6-week (immediate post-intervention) [T1] | 
| Self-care behaviours | Measured with the Diabetes Self-Care Activities (SDSCA) scale | 6-month [T2] | 
| Self-care behaviours | Measured with the Diabetes Self-Care Activities (SDSCA) scale | 12-month [T3] | 
| Positive emotions | Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD) | 6-week (immediate post-intervention) [T1] | 
| Positive emotions | Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD) | 6-month [T2] | 
| Positive emotions | Measure by the Positive Affects subscale of the Center for Epidemiologic Studies Depression Scale (PA-CESD) | 12-month [T3] | 
| HbA1c |  | 6-week (immediate post-intervention) [T1] | 
| HbA1c |  | 6-month [T2] | 
| HbA1c |  | 12-month [T3] | 
| Blood pressure | systolic and diastolic blood pressure | 6-week (immediate post-intervention) [T1] | 
| Blood Pressure | systolic and diastolic blood pressure | 6-month [T2] | 
| Blood pressure | systolic and diastolic blood pressure | 12-month [T3] | 
| LDL-cholesterol | lipid profiles | 6-week (immediate post-intervention) [T1] | 
| LDL-cholesterol | lipid profiles | 6-month [T2] | 
| LDL-cholesterol | lipid profiles | 12-month [T3] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mood Disorders, Self Care, Primary Care