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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universiti Putra Malaysia
- Enrollment
- 124
- Primary Endpoint
- Diabetes-related distress
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Attention-meetings (AG)
Attention-control
Intervention: Attention-meetings (AG) (Behavioral)
VEMOFIT (VG)
Personal value exploration, disease education, emotional skills and goal setting.
Intervention: VEMOFIT (Behavioral)
Outcomes
Primary Outcomes
Diabetes-related distress
Time Frame: 12-month [T3]
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Diabetes-related distress
Time Frame: 6-week (immediate post-intervention) [T1]
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Diabetes-related distress
Time Frame: 6-month [T2]
Measured with the 17-item Diabetes Distress Scale (DDS-17)
Secondary Outcomes
- LDL-cholesterol(12-month [T3])
- Blood Pressure(6-month [T2])
- Illness perception(12-month [T3])
- Positive emotions(12-month [T3])
- HbA1c(12-month [T3])
- Blood pressure(12-month [T3])
- Self-care behaviours(12-month [T3])
- Quality of life(12-month [T3])
- Self-efficacy(12-month [T3])
- Depression(12-month [T3])
- Depression(6-week (immediate post-intervention) [T1])
- Depression(6-month [T2])
- Illness perception(6-week (immediate post-intervention) [T1])
- Illness perception(6-month [T2])
- Quality of life(6-month [T2])
- Self-efficacy(6-week (immediate post-intervention) [T1])
- Self-efficacy(6-month [T2])
- Self-care behaviours(6-week (immediate post-intervention) [T1])
- Self-care behaviours(6-month [T2])
- Positive emotions(6-week (immediate post-intervention) [T1])
- Positive emotions(6-month [T2])
- HbA1c(6-week (immediate post-intervention) [T1])
- HbA1c(6-month [T2])
- Blood pressure(6-week (immediate post-intervention) [T1])
- LDL-cholesterol(6-week (immediate post-intervention) [T1])
- LDL-cholesterol(6-month [T2])
Investigators
Boon-How Chew
Associate Professor
Universiti Putra Malaysia