Department of Psychiatry and Mental Health, Hospital Putrajaya Malaysia, Selangor, Malaysia
Department of Psychiatry, Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Serdang, Malaysia.
BMJ Open. 2020 Feb 16;10(2):e033920. doi: 10.1136/bmjopen-2019-033920.
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.
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.
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.
NCT03601884.
糖尿病患者通常与多方面的因素和合并症有关。糖尿病管理框架需要整合生物心理社会、以患者为中心的方法。尽管在促进和糖尿病教育方面做出了越来越多的努力，但马来西亚仍缺乏同时整合身心健康因素的干预措施。优化健康计划 (OHP) 提供了一个创新的生物心理社会框架，以促进整体健康和自我效能，不仅仅是教育，并且已经被确定与初级保健系统相关。在经过全面的文化适应过程后，马来西亚第一个 OHP 被命名为'Pohon Sihat' (OHP)。本研究旨在评估基于心理健康的自我管理和健康计划在改善初级保健糖尿病患者自我效能和幸福感方面的有效性。
这项生物心理社会干预随机对照试验将招募来自布城四家初级保健诊所的 156 名 2 型糖尿病患者。参与者将被随机分配到 OHP 加常规治疗组。每周一次，每次 2 小时，连续进行五周，然后在 3 个月后进行 2 小时的强化课程，由经过培训的心理健康从业者和糖尿病教育者来进行。主要结果将包括自我效能测量，次要结果将包括幸福感、焦虑、抑郁、自我护理行为和糖化血红蛋白 A1c 葡萄糖测试。将在基线、干预后即刻、3 个月和 6 个月时评估结果测量。在适当的情况下，将进行意向治疗分析。
本研究已获得马来西亚卫生部医学研究和伦理委员会的批准 (NMRR-17-3426-38212)。研究结果将与马来西亚卫生部和参与的医疗保健诊所分享。结果还将通过发表、会议演讲和在同行评议期刊上发表来分享。
NCT03601884。
