Effectiveness of OHP in Improving Self-efficacy in Patients With Diabetes Mellitus

NCT03601884 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2021-04-28

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Optimal Health Program

The Optimal Health Program (OHP) is a self-management psychosocial program that promotes patients to be actively involved in their own healthcare and overall well-being. Sessions include Optimal Health, I-CAN-DO Model, Medication \& Metabolic Monitoring, Collaborative \& Strategies, Change enhancement, Visioning \& Goal Setting and Maintain Well-being.

OTHER

Treatment as Usual

Treatment-as-usual TAU is the pharmacological treatment received or prescribed by the patients' attending doctor. To ensure standardization of treatment, attending doctors will be reminded to manage patients in accordance with the Clinical practice Guideline in Managing Diabetes Melllitus in adult patients.

Sponsors & Collaborators

  • St Vincent's Hospital Melbourne

    collaborator OTHER
  • Universiti Putra Malaysia

    lead OTHER

Principal Investigators

  • Aida F Suhaimi, Ms · Universiti Putra Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-05
Primary Completion
2019-12-31
Completion
2020-02-28

Countries

  • Malaysia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03601884 on ClinicalTrials.gov