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.
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
Author Information
Boon-How Chew: Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. chewboonhow@gmail.com. ORCID
Rimke C Vos: Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Huispost Str.6.131, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
Sazlina Shariff Ghazali: Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Nurainul Hana Shamsuddin: Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Aaron Fernandez: Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Firdaus Mukhtar: Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Mastura Ismail: Health Clinic Seremban 2, Jalan S2, A2, Seremban 2, 27300, Seremban, Negeri Sembilan, Malaysia.
Azainorsuzila Mohd Ahad: Health Clinic Port Dickson, KM 1, Jalan Seremban-Port Dickson, 71000, Port Dickson, Negeri Sembilan, Malaysia.
Narayanan N Sundram: Health Clinic Nilai, 71800, Nilai, Negeri Sembilan, Malaysia.
Siti Zubaidah Mohd Ali: Health Clinic Seremban, Jalan Rasah, 70300, Seremban, Negeri Sembilan, Malaysia.
Guy E H M Rutten: Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Huispost Str.6.131, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
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.
