Chew 2018.
| Study characteristics | |
| Methods |
Study design: cluster‐RCT Duration of study: the study was conducted from April 2016 to February 2018. Country: Malaysia Income classification: upper‐middle‐income country from 2016 to 2018 Geographical scope: not specified Healthcare setting: 10 public health clinics in Malaysia |
| Participants | 1. Age: mean (SD) age: 55.6 (10.8) 2. Gender: both 3. Socioeconomic background: not specified 4. Educational background: not specified Inclusion criteria: a. Malay individuals; b. aged ≥ 18 years; c. diagnosed with type 2 diabetes for at least 2 years and having regular follow‐up; d. presenting with a mean score ≥ 3 on the 17‐item Diabetes Distress Scale (DDS‐17); e. with either HbA1c ≥ 64 mmol/mol (8.0%), blood pressure ≥ 140/90 mmHg or LDL level ≥ 2.6 mmol/L. Exclusion criteria: a. being pregnant or lactating; b. having a known psychiatric/psychological disorder that could impair judgement and memory; c. unable to read or understand English or Malay; d. score ≥ 20 on the 9‐item Patient Health Questionnaire 9 (PHQ‐9). Note: at baseline, the intervention and control group scores for the PHQ‐9 were, respectively, 4.3 (3.3) and 6.0 (4.8). Stated purpose: to evaluate the effectiveness of a brief, value‐based emotion‐cognition‐focused educational program (VEMOFIT) in Malay adults with type 2 diabetes mellitus |
| Interventions |
Name: Value‐Based and Emotion‐Focused Educational Programme (VEMOFIT) Title/name of PW and number: nurse‐coaches and doctors (number not specified) 1. Selection: not specified 2. Educational background: healthcare background (nurses and doctors) 3. Training: nurse‐coaches and doctors were trained to conduct both programmes at their own health clinics, supported by respective intervention materials and presentation slides. 4. Supervision: not specified 5. Incentives/remuneration: not specified Prevention type: indicated prevention – intervention aimed at adults with type 2 diabetes mellitus presenting with distress but excluding those with a score on the Patient Health Questionnaire 9 (PHQ‐9) indicative of severe depression Intervention details: the VEMOFIT consisted of four biweekly group sessions exploring personal values and providing diabetes education (session 1), a training on recognizing (session 2) and managing emotions (session 3) in the self and others, providing social support and setting short‐ and long‐term goals (session 4), and a booster session 3 months after the last session of the main intervention, reviewing the patient’s goals and rehearsing the content of the fourth session. Each participant was allowed to bring along one significant other as a co‐participant. Control: active control – participants in the attention control program were offered three sessions over the same period to discuss emotional experiences, social support at home, and health clinic services regarding diabetes. They were not accompanied, and the sessions were not structured according to any module. The nurse‐coaches and doctors leading the attention control programme were trained in active listening. |
| Outcomes |
Participants’outcomes of interest for this review
Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (< 1 month, 1‐6 months, 7‐24 months) |
| Notes |
Source of funding: the trial is funded by the Malaysian MOHNIH Research Grant (MRG). This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. Notes on validation of instruments (screening and outcomes): the Malay versions of the DDS, PHQ‐9, and Summary of Diabetes Self‐Care Activities (SDSCA) were reported to be validated. Additional information: none Handling the data: not applicable Prospective trial registration number: NCT02730078 |