PMID- 28376921 OWN - NLM STAT- MEDLINE DCOM- 20180308 LR - 20220408 IS - 1472-6823 (Electronic) IS - 1472-6823 (Linking) VI - 17 IP - 1 DP - 2017 Apr 4 TI - 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. PG - 22 LID - 10.1186/s12902-017-0172-8 [doi] LID - 22 AB - 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 rho 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. FAU - Chew, Boon-How AU - Chew BH AUID- ORCID: 0000-0002-8627-6248 AD - Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. chewboonhow@gmail.com. AD - 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. FAU - Vos, Rimke C AU - Vos RC AD - 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. FAU - Shariff Ghazali, Sazlina AU - Shariff Ghazali S AD - Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. FAU - Shamsuddin, Nurainul Hana AU - Shamsuddin NH AD - Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. FAU - Fernandez, Aaron AU - Fernandez A AD - Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. FAU - Mukhtar, Firdaus AU - Mukhtar F AD - Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia. FAU - Ismail, Mastura AU - Ismail M AD - Health Clinic Seremban 2, Jalan S2, A2, Seremban 2, 27300, Seremban, Negeri Sembilan, Malaysia. FAU - Mohd Ahad, Azainorsuzila AU - Mohd Ahad A AD - Health Clinic Port Dickson, KM 1, Jalan Seremban-Port Dickson, 71000, Port Dickson, Negeri Sembilan, Malaysia. FAU - Sundram, Narayanan N AU - Sundram NN AD - Health Clinic Nilai, 71800, Nilai, Negeri Sembilan, Malaysia. FAU - Ali, Siti Zubaidah Mohd AU - Ali SZ AD - Health Clinic Seremban, Jalan Rasah, 70300, Seremban, Negeri Sembilan, Malaysia. FAU - Rutten, Guy E H M AU - Rutten GE AD - 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. LA - eng SI - ClinicalTrials.gov/NCT02730078 PT - Journal Article PT - Randomized Controlled Trial DEP - 20170404 PL - England TA - BMC Endocr Disord JT - BMC endocrine disorders JID - 101088676 SB - IM MH - Adult MH - Cluster Analysis MH - *Cognition MH - Diabetes Mellitus, Type 2/*epidemiology/psychology/*therapy MH - *Emotions MH - Female MH - Follow-Up Studies MH - Humans MH - Malaysia/epidemiology MH - Male MH - Patient Education as Topic/*methods MH - Pilot Projects MH - Self Care/*methods MH - Surveys and Questionnaires MH - Treatment Outcome PMC - PMC5379686 OTO - NOTNLM OT - Blood pressure OT - Depression OT - Diabetes education OT - Diabetes-related distress OT - HbA1c OT - LDL-cholesterol OT - Quality of life OT - Self-care OT - Type 2 diabetes mellitus EDAT- 2017/04/06 06:00 MHDA- 2018/03/09 06:00 PMCR- 2017/04/04 CRDT- 2017/04/06 06:00 PHST- 2017/01/18 00:00 [received] PHST- 2017/03/23 00:00 [accepted] PHST- 2017/04/06 06:00 [entrez] PHST- 2017/04/06 06:00 [pubmed] PHST- 2018/03/09 06:00 [medline] PHST- 2017/04/04 00:00 [pmc-release] AID - 10.1186/s12902-017-0172-8 [pii] AID - 172 [pii] AID - 10.1186/s12902-017-0172-8 [doi] PST - epublish SO - BMC Endocr Disord. 2017 Apr 4;17(1):22. doi: 10.1186/s12902-017-0172-8.