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.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02730078 . Registered on 29 March 2016, last updated on 4 January 2017.
authors.affiliation: Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. chewboonhow@gmail.com.|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. chewboonhow@gmail.com.
authors.forename: Boon-How
authors.identifier: http://orcid.org/0000-0002-8627-6248
authors.initials: BH
authors.lastname: Chew
authors.affiliation: 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.
authors.forename: Rimke C
authors.initials: RC
authors.lastname: Vos
authors.affiliation: Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
authors.forename: Sazlina
authors.initials: S
authors.lastname: Shariff Ghazali
authors.affiliation: Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
authors.forename: Nurainul Hana
authors.initials: NH
authors.lastname: Shamsuddin
authors.affiliation: Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
authors.forename: Aaron
authors.initials: A
authors.lastname: Fernandez
authors.affiliation: Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
authors.forename: Firdaus
authors.initials: F
authors.lastname: Mukhtar
authors.affiliation: Health Clinic Seremban 2, Jalan S2, A2, Seremban 2, 27300, Seremban, Negeri Sembilan, Malaysia.
authors.forename: Mastura
authors.initials: M
authors.lastname: Ismail
authors.affiliation: Health Clinic Port Dickson, KM 1, Jalan Seremban-Port Dickson, 71000, Port Dickson, Negeri Sembilan, Malaysia.
authors.forename: Azainorsuzila
authors.initials: A
authors.lastname: Mohd Ahad
authors.affiliation: Health Clinic Nilai, 71800, Nilai, Negeri Sembilan, Malaysia.
authors.forename: Narayanan N
authors.initials: NN
authors.lastname: Sundram
authors.affiliation: Health Clinic Seremban, Jalan Rasah, 70300, Seremban, Negeri Sembilan, Malaysia.
authors.forename: Siti Zubaidah Mohd
authors.initials: SZ
authors.lastname: Ali
authors.affiliation: 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.
authors.forename: Guy E H M
authors.initials: GE
authors.lastname: Rutten
mesh_terms: D000328:Adult; D016000:Cluster Analysis; D003071:Cognition; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology* / Q000523:psychology / Q000628:therapy*; D004644:Emotions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008296:Malaysia / Q000453:epidemiology; D008297:Male; D010353:Patient Education as Topic / Q000379:methods*; D010865:Pilot Projects; D012648:Self Care / Q000379:methods*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Blood pressure; Depression; Diabetes education; Diabetes-related distress; HbA1c; LDL-cholesterol; Quality of life; Self-care; Type 2 diabetes mellitus