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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.
BMJ Open. 2020 02 16; 10(2):e033920.BO

Abstract

INTRODUCTION

People 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 ANALYSIS

This 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 DISSEMINATION

This 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 NUMBER

NCT03601884.

Authors+Show Affiliations

Department of Psychiatry and Mental Health, Hospital Putrajaya Malaysia, Selangor, Malaysia aida.hjsuhaimi@gmail.com. Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Serdang, Malaysia.Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Serdang, Malaysia.Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Serdang, Malaysia.Department of Psychiatry and Mental Health, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.Centre for Palliative Care, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.International Unit, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.Department of Psychiatry, St. Vincent's Mental Health, Melbourne, Victoria, Australia.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32066607

Citation

Suhaimi, Aida Farhana, et al. "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." BMJ Open, vol. 10, no. 2, 2020, pp. e033920.
Suhaimi AF, Ibrahim N, Tan KA, et al. 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. BMJ Open. 2020;10(2):e033920.
Suhaimi, A. F., Ibrahim, N., Tan, K. A., Silim, U. A., Moore, G., Ryan, B., & Castle, D. J. (2020). 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. BMJ Open, 10(2), e033920. https://doi.org/10.1136/bmjopen-2019-033920
Suhaimi AF, et al. 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. BMJ Open. 2020 02 16;10(2):e033920. PubMed PMID: 32066607.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Suhaimi,Aida Farhana, AU - Ibrahim,Normala, AU - Tan,Kit-Aun, AU - Silim,Umi Adzlin, AU - Moore,Gaye, AU - Ryan,Brigid, AU - Castle,David J, Y1 - 2020/02/16/ PY - 2020/2/19/entrez PY - 2020/2/19/pubmed PY - 2020/2/19/medline KW - PRIMARY CARE KW - biopsychosocial KW - diabetes KW - self-efficacy KW - self-management SP - e033920 EP - e033920 JF - BMJ open JO - BMJ Open VL - 10 IS - 2 N2 - INTRODUCTION: People 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 ANALYSIS: This 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 DISSEMINATION: This 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 NUMBER: NCT03601884. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/32066607/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 L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=32066607 DB - PRIME DP - Unbound Medicine ER -
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