Diabetes Mellitus Clinical Trial
— OHPOfficial title:
Effectiveness of Optimal Health Program in Improving Self-efficacy in Patients With Diabetes Mellitus in Putrajaya, Malaysia
Verified date | April 2021 |
Source | Universiti Putra Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 127 |
Est. completion date | February 28, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | Klinik Kesihatan Presint 11 | Putrajaya | |
Malaysia | Klinik Kesihatan Presint 14 | Putrajaya | |
Malaysia | Klinik Kesihatan Presint 18 | Putrajaya | |
Malaysia | Klinik Kesihatan Presint 9 | Putrajaya |
Lead Sponsor | Collaborator |
---|---|
Universiti Putra Malaysia | St Vincent's Hospital Melbourne |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in Diabetes Empowerment Scale (DES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time | 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. | Week 1, Week 5, Week 18, Week 30 | |
Primary | 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 | 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). |
Week 1, Week 5, Week 18, Week 30 | |
Secondary | Difference in PHQ scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time | 9 item self-administered measurement that assess depression | Week 1, Week 5, Week 18, Week 30 | |
Secondary | Difference in GAD scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time | 7 item self-administered measurement that assess depression | Week 1, Week 5, Week 18, Week 30 | |
Secondary | Difference in PAID-20 scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time | 20 item self-administered measurement that assess diabetes related distress. | Week 1, Week 5, Week 18, Week 30 | |
Secondary | Difference in WHO-5 scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time | 5 item self-administered measurement that assess wellbeing | Week 1, Week 5, Week 18, Week 30 | |
Secondary | Difference in diabetes self-care behaviours scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time | 10 item self-administered measurement that assess diabetes self-care behaviours | Week 1, Week 5, Week 18, Week 30 | |
Secondary | Difference in HbA1c between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time | Glycaemic control as assessed by HbA1c level | Week 1, Week 30 |
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