PMID- 32066607
OWN - NLM
STAT- MEDLINE
DCOM- 20210408
LR  - 20210408
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 10
IP  - 2
DP  - 2020 Feb 16
TI  - 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.
PG  - e033920
LID - 10.1136/bmjopen-2019-033920 [doi]
LID - e033920
AB  - 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.
CI  - (c) Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Suhaimi, Aida Farhana
AU  - Suhaimi AF
AUID- ORCID: 0000-0001-5299-3831
AD  - Department of Psychiatry and Mental Health, Hospital Putrajaya Malaysia, 
      Selangor, Malaysia aida.hjsuhaimi@gmail.com.
AD  - Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and 
      Health Sciences, Serdang, Malaysia.
FAU - Ibrahim, Normala
AU  - Ibrahim N
AD  - Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and 
      Health Sciences, Serdang, Malaysia.
FAU - Tan, Kit-Aun
AU  - Tan KA
AD  - Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and 
      Health Sciences, Serdang, Malaysia.
FAU - Silim, Umi Adzlin
AU  - Silim UA
AD  - Department of Psychiatry and Mental Health, Hospital Kuala Lumpur, Kuala Lumpur, 
      Wilayah Persekutuan, Malaysia.
FAU - Moore, Gaye
AU  - Moore G
AD  - Centre for Palliative Care, St. Vincent's Hospital Melbourne, Melbourne, 
      Victoria, Australia.
FAU - Ryan, Brigid
AU  - Ryan B
AD  - International Unit, St. Vincent's Hospital Melbourne, Melbourne, Victoria, 
      Australia.
FAU - Castle, David J
AU  - Castle DJ
AD  - Department of Psychiatry, St. Vincent's Mental Health, Melbourne, Victoria, 
      Australia.
LA  - eng
SI  - ClinicalTrials.gov/NCT03601884
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200216
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - *Culturally Competent Care
MH  - *Diabetes Mellitus, Type 2/psychology/therapy
MH  - Humans
MH  - Malaysia
MH  - Patient-Centered Care
MH  - Primary Health Care
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - *Self Efficacy
PMC - PMC7044963
OTO - NOTNLM
OT  - PRIMARY CARE
OT  - biopsychosocial
OT  - diabetes
OT  - self-efficacy
OT  - self-management
COIS- 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.
EDAT- 2020/02/19 06:00
MHDA- 2021/04/10 06:00
PMCR- 2020/02/16
CRDT- 2020/02/19 06:00
PHST- 2020/02/19 06:00 [entrez]
PHST- 2020/02/19 06:00 [pubmed]
PHST- 2021/04/10 06:00 [medline]
PHST- 2020/02/16 00:00 [pmc-release]
AID - bmjopen-2019-033920 [pii]
AID - 10.1136/bmjopen-2019-033920 [doi]
PST - epublish
SO  - BMJ Open. 2020 Feb 16;10(2):e033920. doi: 10.1136/bmjopen-2019-033920.