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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: VEMOFIT; Behavioral: Attention-meetings (AG)

• Registration Number: NCT02730078
• Lead Sponsor: Universiti Putra Malaysia

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 Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-31
• Study Start: 2016-04
• Study First Posted: 2016-04-06
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VEMOFIT (VG)	VEMOFIT	Personal value exploration, disease education, emotional skills and goal setting.
Attention-meetings (AG)	Attention-meetings (AG)	Attention-control

Primary Outcome Measures

Name	Time	Method
Diabetes-related distress	12-month [T3]	Measured with the 17-item Diabetes Distress Scale (DDS-17)

Secondary Outcome Measures

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