Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness of Optimal Health Program in Improving Self-efficacy in Patients With Diabetes Mellitus in Putrajaya, Malaysia
Brief Summary: 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.


Options:
A: Arm Label: OHP and Treatment as usual (TAU); Type: EXPERIMENTAL; Interventions: Behavioral: Optimal Health Program, Other: Treatment as Usual | Arm Label: TAU Alone; Type: OTHER; Interventions: Other: Treatment as Usual | Intervention Type: BEHAVIORAL; Name: Optimal Health Program; Assigned to Arm(s): OHP and Treatment as usual (TAU) | Intervention Type: OTHER; Name: Treatment as Usual; Assigned to Arm(s): OHP and Treatment as usual (TAU), TAU Alone
B: Arm Label: Philani Intervention Program; Type: EXPERIMENTAL; Interventions: Behavioral: Philani Intervention Program | Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Philani Intervention Program; Assigned to Arm(s): Philani Intervention Program
C: Arm Label: Accountable Condition- 8 clinics; Type: EXPERIMENTAL; Interventions: Behavioral: Accountable Condition | Arm Label: Control Condition- 8 clinics; Type: EXPERIMENTAL; Interventions: Behavioral: Control Condition | Intervention Type: BEHAVIORAL; Name: Accountable Condition; Assigned to Arm(s): Accountable Condition- 8 clinics | Intervention Type: BEHAVIORAL; Name: Control Condition; Assigned to Arm(s): Control Condition- 8 clinics
D: Arm Label: Abangane Support Group; Type: EXPERIMENTAL; Interventions: Behavioral: Abangane Support Group | Arm Label: Wait List; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Abangane Support Group; Assigned to Arm(s): Abangane Support Group

Answer: A