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

University of Putra Malaysia (UPM)

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Behavioral: VEMOFIT

Behavioral: Attention-meetings (AG)

Study type

Interventional

Funder types

Other

Identifiers

NCT02730078

NMRR- 15-1144-24803

Details and patient eligibility

About

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.

Full 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.

Enrollment

124 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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