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

NCT02730078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2019-07-12

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

VEMOFIT

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.

BEHAVIORAL

Attention-meetings (AG)

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.

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    collaborator OTHER_GOV

  • UMC Utrecht

    collaborator OTHER

  • Universiti Putra Malaysia

    lead OTHER

Principal Investigators

  • Boon-How Chew, MMed · Universiti Putra Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-31
Completion
2017-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730078 on ClinicalTrials.gov