Effectiveness of a culturally adapted biopsychosocial intervention (POHON SIHAT) in improving self-efficacy in patients with diabetes attending primary healthcare clinics in Putrajaya, Malaysia: study protocol of a randomised controlled trial

Abstract

IntroductionPeople with diabetes are often associated with multifaceted factors and comorbidities. Diabetes management frameworks need to integrate a biopsychosocial, patient-centred approach. Despite increasing efforts in promotion and diabetes education, interventions integrating both physical and mental health components are still lacking in Malaysia. The Optimal Health Programme (OHP) offers an innovative biopsychosocial framework to promote overall well-being and self-efficacy, going beyond education alone and has been identified as relevant within the primary care system. Following a comprehensive cultural adaptation process, Malaysia’s first OHP was developed under the name ‘Pohon Sihat’ (OHP). The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus.Methods and analysisThis biopsychosocial intervention randomised controlled trial will engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya. Participants will be randomised to either OHP plus treatment as usual. The 2-hour weekly sessions over five consecutive weeks, and 2-hour booster session post 3 months will be facilitated by trained mental health practitioners and diabetes educators. Primary outcomes will include self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test. Outcome measures will be assessed at baseline, immediately postintervention, as well as at 3 months and 6 months postintervention. Where appropriate, intention-to-treat analyses will be performed.Ethics and disseminationThis study has ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-17-3426-38212). Study findings will be shared with the Ministry of Health Malaysia and participating healthcare clinics. Outcomes will also be shared through publication, conference presentations and publication in a peer-reviewed journal.Trial registration numberNCT03601884.

Translation and Validation of the Malay Version of the WHO-5 Well-Being Index: Reliability and Validity Evidence from a Sample of Type 2 Diabetes Mellitus Patients

“…This manuscript was part of an intervention study examining the effectiveness of a well-being self-management program in T2DM patients in primary care clinics [ 31 ]. We used subject-to-item ratios of 20:1 to calculate sample size [ 32 ].…”

“…Participants completed a research questionnaire containing the final version of the WHO-5 Malay along with socio-demographic measures (age, gender, ethnicity, religion, employment status, marital status, diabetes complications, duration since diagnosed with diabetes), the Patient Health Questionnaire (PHQ-9), the Problem Areas in Diabetes (PAID-20), the Summary of Diabetes Self-Care Activities Measure (SDSCA), and the Diabetes Management Self-Efficacy scale (DMSES). At 5-week follow-up, all participants were invited to complete the WHO-5 Malay for test–retest assessment, in line with the time point assessment of the intervention study [ 31 ]. Of 127 participants invited for test–retest assessment, 119 participants completed the WHO-5 Malay at 5-week after the initial assessment was done.…”

Initial evaluation of the Optimal Health Program for people with diabetes: 12-month outcomes of a randomised controlled trial

“…Further research of the new MINDS OHP including multi-centre trials with more diverse groups of participants is recommended. Efforts towards this include a culturally adapted version of the OHP (POHON SIHAT) being trialled in Malaysia for people with diabetes (Suhaimi et al, 2020).…”

Promoting participatory research in chronicity: The ESPRIMO biopsychosocial intervention for young adults with multiple sclerosis

“…However, literature on the development of integrated interventions for CDs targeting all such different domains at the same time seems still scattered. Some efforts have been made on different CDs such as, for example, chronic low back pain ( Kamper et al, 2014 ), stroke care ( Kontou et al, 2022 ) and diabetes mellitus ( Suhaimi et al, 2020 ). More extensive research is needed to tackle the burden of CDs, especially in a neurodegenerative life-limiting chronic condition such as multiple sclerosis (MS), a field in which, to the best of our knowledge, biopsychosocial interventions have not been developed yet.…”