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

NCT03601884 | Completed DMC

• 1 other identifier: OHPMALAYSIA
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes Mellitus; Chronic Illness

Keywords

Well-being; Self-efficacy; Self-management; Psychosocial; Malaysia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• 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

• 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 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 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

Study Arms (2)

OHP and Treatment as usual (TAU)

EXPERIMENTAL

Optimal Health Program (OHP) A self-management program that promotes patients to be actively involved in their own healthcare and overall well-being through enhancing self-efficacy. Treatment is delivered by a trained facilitator in OHP. The OHP is delivered in groups of 8 to 10 participants It consists of 5 weekly, 1.5 hour sessions and an additional booster session post-program at 3 months a The group facilitator will contact the participants by phone at 8 weeks and 16 weeks. 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.

Behavioral: Optimal Health Program; Other: Treatment as Usual

TAU Alone

OTHER

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.

Other: Treatment as Usual

Interventions

Optimal Health Program BEHAVIORAL

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.

Also known as: OHP, Wellbeing Psychosocial Program

OHP and Treatment as usual (TAU)

Treatment as Usual OTHER

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.

Also known as: TAU

OHP and Treatment as usual (TAU); TAU Alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• St Vincent's Hospital Melbourne: collaborator

Study Sites (4)

Klinik Kesihatan Presint 11

Putrajaya, 62300, Malaysia

Location

Klinik Kesihatan Presint 14

Putrajaya, 62300, Malaysia

Location

Klinik Kesihatan Presint 18

Putrajaya, 62300, Malaysia

Location

Klinik Kesihatan Presint 9

Putrajaya, 62300, Malaysia

Location

Related Publications (1)

• Suhaimi AF, Ibrahim N, Tan KA, Silim UA, Moore G, Ryan B, Castle DJ. Effectiveness of a culturally adapted biopsychosocial intervention (POHON SIHAT) in improving self-efficacy in patients with diabetes attending primary healthcare clinics in Putrajaya, Malaysia: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 16;10(2):e033920. doi: 10.1136/bmjopen-2019-033920.

  PMID: 32066607 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aida F Suhaimi, Ms

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: This study is a Randomised Controlled Trial. The sampling frame will be patients with diabetes registered in all the government health clinics located in Putrajaya. Patients are screened at the beginning and later interviewed using a structured questionnaire and intake interview. All four Health Clinics in Putrajaya will participate in the study, randomization will be conducted at the facility level. This study is a two arm - experimental vs. control group RCT. Participants are randomly allocated at facility level. All four health clinics will be randomly assigned to the OHP and TAU (experimental group) or TAU (control group), with two health clinics randomly allocated in the experimental group and another two the control group.

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 26, 2018
• Study Start: October 5, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 28, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (4)