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

Autor: 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
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Zdroj: BMC Endocrine Disorders, Vol 17, Iss 1, Pp 1-13 (2017)
Druh dokumentu: article
ISSN: 1472-6823
DOI: 10.1186/s12902-017-0172-8
Popis: 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
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