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BMC Endocrine Disorders
Published in: BMC Endocrine Disorders 1/2017

Open Access 01-12-2017 | Study protocol

The effectiveness of a value-based EMOtion-cognition-Focused educatIonal programme to reduce diabetes-related distress in Malay adults with Type 2 diabetes (VEMOFIT): study protocol for a cluster randomised controlled trial

Authors: Boon-How Chew, Rimke C. Vos, Sazlina Shariff Ghazali, Nurainul Hana Shamsuddin, Aaron Fernandez, Firdaus Mukhtar, Mastura Ismail, Azainorsuzila Mohd Ahad, Narayanan N. Sundram, Siti Zubaidah Mohd Ali, Guy E. H. M. Rutten

Published in: BMC Endocrine Disorders | Issue 1/2017

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Abstract

Background

Type 2 diabetes mellitus (T2DM) patients experience many psychosocial problems related to their diabetes. These often lead to emotional disorders such as distress, stress, anxiety and depression, resulting in decreased self-care, quality of life and disease control. The purpose of the current study is to evaluate the effectiveness of a brief value-based emotion-focused educational programme in adults with T2DM on diabetes-related distress (DRD), depressive symptoms, illness perceptions, quality of life, diabetes self-efficacy, self-care and clinical outcomes.

Methods

A cluster randomised controlled trial will be conducted in 10 public health clinics in Malaysia, all providing diabetes care according to national clinical practice guidelines. Patients’ inclusion criteria: Malay, ≥ 18 years with T2DM for at least 2 years, on regular follow-up with one of three biomarkers HbA1c, systolic blood pressure and LDL-cholesterol sub-optimally controlled, and with a mean 17-item Diabetes Distress Scale (DDS-17) score ≥ 3. The intervention consists of four sessions and one booster over a period of 4 months that provide information and skills to assist patients in having proper perceptions of their T2DM including an understanding of the treatment targets, understanding and managing their emotions and goal-setting. The comparator is an attention-control group with three meetings over a similar period. With an estimated intra-cluster correlation coefficient ρ of 0.015, a cluster size of 20 and 20% non-completion, the trial will need to enroll 198 patients. Primary outcome: the between groups difference in proportion of patients achieving a mean DDS-17 score < 3 (non-significant distress) at 6 months post-intervention. Secondary outcomes will be the differences in the above mentioned variables between groups.

Discussion

We hypothesize that primary and secondary outcomes will improve significantly after the intervention compared to the comparator group. The results of this study can contribute to better care for T2DM patients with DRD.

Trial registration

ClinicalTrials.gov NCT02730078. Registered on 29 March 2016, last updated on 4 January 2017.
Appendix
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Metadata
Title
The effectiveness of a value-based EMOtion-cognition-Focused educatIonal programme to reduce diabetes-related distress in Malay adults with Type 2 diabetes (VEMOFIT): study protocol for a cluster randomised controlled trial
Authors
Boon-How Chew
Rimke C. Vos
Sazlina Shariff Ghazali
Nurainul Hana Shamsuddin
Aaron Fernandez
Firdaus Mukhtar
Mastura Ismail
Azainorsuzila Mohd Ahad
Narayanan N. Sundram
Siti Zubaidah Mohd Ali
Guy E. H. M. Rutten
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Endocrine Disorders / Issue 1/2017
Electronic ISSN: 1472-6823
DOI
https://doi.org/10.1186/s12902-017-0172-8

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