Effectiveness of Optimal Health Program in Improving Self-efficacy in Patients With Diabetes Mellitus in Putrajaya, Malaysia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 8
- 主要终点
- Difference in Diabetes Management Self-Efficacy Scale (DMSES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time
研究概览
简要总结
Addressing the increasing trend in diabetes and mental illness co-morbidities, Malaysia is currently in need of a self- management program that promotes patient empowerment and overall well-being - beyond education. Committing to the self-care behaviours is highly dependent on the individual's self-efficacy. Self-efficacy has been shown to have a direct positive relationship with self-care behaviours, direct negative relationship with psychological distress and depression. Self-efficacy has also been found to hold a mediating effect on the relationship between emotional distress and self-care behaviours.
The objective of this study is to assess the effectiveness of a self-management program for patients with diabetes, the Optimal Health Program (OHP) in improving self-efficacy, depression, anxiety, diabetes distress, well-being and self-care. This study is a randomized controlled trial study of patients with diabetes attending the four diabetes health clinics within the Putrajaya District. Eligible patients will be randomly allocated to either treatment as usual (TAU) or OHP and treatment as usual (OHP + TAU). The treatment as usual group (TAU) participants will be invited to participate in the OHP at the end of the study. The participants in the OHP + TAU will attend 5 weekly 1.5 hour sessions and a booster session at 3 months. Following ethics approval, recruitment and training will commence in September, data collection expected to be until April 2020.
It is hypothesized that the OHP + TAU group will have higher self-efficacy, well-being and self-care scores and reduced depression, anxiety, diabetes related-distress and HbA1c. This study will contribute towards the gap in the literature in the effectiveness of a self-efficacy enhancing psychosocial self-management program among diabetes patients in Malaysia within a primary care setting.
详细描述
Background and Significance
Diabetes currently affects 1 in 5 adults, with the most affected within the productive age span and an expectation of continual increase in the future. Mirroring the global trend, Malaysia has approximately 2.6 million adults having diabetes mellitus in Malaysia with an up to 31% increase from 2006 to 2011. The complexity of diabetes mellitus itself is associated with not just the physical health but also the patients' emotional well-being and mental health, social, occupational and overall quality of life. The current blooming diabetes population with increasing psychosocial barriers brings about a huge impact on the complexity of diabetes. Psychosocial self-management is central to effective management in diabetes. Nonetheless, committing to the self-care behaviours is highly dependent on the individual's self-efficacy.
Self-efficacy is the individual's belief about their capabilities to cope and manage their diabetes. Self-efficacy can be assessed based on the individual's perceived ability - (1) to conduct the specific diabetes self-care activities and (2) to manage their psychosocial issues related to diabetes psychosocial self-efficacy. Self-efficacy has been shown to have a direct positive relationship with self-care behaviours 4, direct negative relationship with psychological distress and depression. Self-efficacy has also been found to hold a mediating effect on the relationship between emotional distress and self-care behaviours.
Addressing the increasing trend in diabetes and mental illness comorbidities, Malaysia is currently in need of a self- management program that promotes patient empowerment and overall well-being - beyond education. With limited mental health professionals and resources, there is a greater need to build the capacity of the health care system especially within the primary care setting. A low intensity intervention program that plays a preventative as well as a curative role conducted within the primary care setting would be of great significant.
Based on the theory of Self-Efficacy, the Optimal Health Program (OHP) is a self-efficacy enhancing management program that promotes patients to be actively involved in their own healthcare and overall well-being. The aim of OHP is to improve a person's health literacy and overall wellbeing through self-efficacy and understanding their strengths and vulnerabilities. Evidently, OHP has shown to be effective in improving health and social functioning in mental health patients, substance use and psychotic disorders. The OHP has slowly expanded towards managing physical health and chronic illnesses. Due to its holistic approach by addressing multiple areas of an individual's life creates tremendous potential in the management of the complexity of chronic illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
To reduce performance bias after the randomization process, blinding is adopted. However, due to the conflicting requirements of ethical and methodological aspects in designing a randomized controlled trial with a psychosocial intervention, double blinding and randomizing each individual participant posits a huge challenge. Patients, the attending doctors and the co-author involved in randomly assigning the group will be blinded in a way that none of them will know which group is considered the experimental group and the control group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a known diagnosis of Diabetes Mellitus Type 2 given by their attending physicians,
- •aged between 18 to 65 years old
- •currently attending the health clinics in Putrajaya.
- •able to provide consent independently without assistance.
排除标准
- •patients that are not able to write and read,
- •does not understand Malay or English,
- •has a serious acute medical illness (e.g. delusional, delirium) during the intake.
- •Patients who are currently attending intensive psychological treatment
结局指标
主要结局
Difference in Diabetes Management Self-Efficacy Scale (DMSES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time
时间窗: Week 1, Week 5, Week 18, Week 30
A 20-item self-administered measurement that assess self-efficacy in managing specific diabetes self-care behaviours. All items are rated between 0 (Not at all confident) to 10 (totally confident). The sum of all items range between 0 (no self-efficacy) to 100 (very high self-efficacy).
Difference in Diabetes Empowerment Scale (DES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time
时间窗: Week 1, Week 5, Week 18, Week 30
Diabetes Empowerment Scale (DES) An 8 item self-administered measurement that assesses the overall diabetes-related psychosocial self-efficacy. All 8 items are rated from 0 (strongly disagree) to 4 (strongly agree). The sum of all items ranged from 0 to 32. Higher scores indicate greater psychosocial self-efficacy.
次要结局
- Difference in PAID-20 scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time(Week 1, Week 5, Week 18, Week 30)
- Difference in diabetes self-care behaviours scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time(Week 1, Week 5, Week 18, Week 30)
- Difference in HbA1c between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time(Week 1, Week 30)
- Difference in WHO-5 scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time(Week 1, Week 5, Week 18, Week 30)
- Difference in PHQ scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time(Week 1, Week 5, Week 18, Week 30)
- Difference in GAD scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time(Week 1, Week 5, Week 18, Week 30)
研究者
Aida Farhana Suhaimi
Clinical Psychologist
Universiti Putra Malaysia