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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.
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- Author(s): Suhaimi AF;Suhaimi AF;Suhaimi AF; Ibrahim N; Ibrahim N; Tan KA; Tan KA; Silim UA; Silim UA; Moore G; Moore G; Ryan B; Ryan B; Castle DJ; Castle DJ
- Source:
BMJ open [BMJ Open] 2020 Feb 16; Vol. 10 (2), pp. e033920. Date of Electronic Publication: 2020 Feb 16.- Publication Type:
Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't- Language:
English - Source:
- Additional Information
- Source: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
- Publication Information: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
- Subject Terms:
- 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.
Competing Interests: Competing interests: DJC has received grant monies for research from Eli Lilly, Janssen Cilag, Roche, Allergen, Bristol-Myers Squibb, Pfizer, Lundbeck, Astra Zeneca, Hospira; Travel Support and Honoraria for Talks and Consultancy from Eli Lilly, Bristol-Myers Squibb, Astra Zeneca, Lundbeck, Janssen Cilag, Pfizer, Organon, Sanofi-Aventis, Wyeth, Hospira, Servier; and is a current Advisory Board Member for Lu AA21004: Lundbeck; Varenicline: Pfizer; Asenapine: Lundbeck; Bitopertin: Roche Aripiprazole LAI: Lundbeck; Lisdexamfetamine: Shire; Lurasidone: Servier. He has no stocks or shares in any pharmaceutical company.
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J Educ Health Promot. 2013 Jul 31;2:36. (PMID: 24083286) - Contributed Indexing: Keywords: PRIMARY CARE; biopsychosocial; diabetes; self-efficacy; self-management
- Molecular Sequence: ClinicalTrials.gov NCT03601884
- Publication Date: Date Created: 20200219 Date Completed: 20210408 Latest Revision: 20210408
- Publication Date: 20221213
- Accession Number: PMC7044963
- Accession Number: 10.1136/bmjopen-2019-033920
- Accession Number: 32066607
- Source:
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