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Diabetes MellitusOHPNCT03601884

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

A study testing Optimal Health Program and Treatment as Usual in people with Diabetes Mellitus and Chronic Illness, run by Universiti Putra Malaysia at 4 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Chronic Illness
What is being tested?
Optimal Health Program and Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
4 sitesMalaysia
Study dates
5 Oct 2018to 28 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Malaysia4 sites
  • Klinik Kesihatan Presint 11

    Putrajaya, 62300

  • Klinik Kesihatan Presint 14

    Putrajaya, 62300

  • Klinik Kesihatan Presint 18

    Putrajaya, 62300

  • Klinik Kesihatan Presint 9

    Putrajaya, 62300

Other trials in Malaysia

About this study

Official title: Effectiveness of Optimal Health Program in Improving Self-efficacy in Patients With Diabetes Mellitus in Putrajaya, Malaysia

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.

Read the detailed description

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.

OHP will be the first engagement tool in Malaysia that will allow health care professionals to address the mental health issues and promote overall wellbeing in these chronic ill patients. OHP is a low intensity intervention program that can be delivered by trained facilitators. The delivery of self-management programs has been shown to be equally effective when delivered by diabetes educators, peers, practice staffs as well as specifically trained program facilitators.

Through the OHP it is hope that it will provide a low intensity intervention program for early intervention within the primary care setting that can be delivered by a broad range of health care providers. It offers a platform for wide range of health care providers within the primary care to engage in a discussion with patients regarding their well-being through a patient centered collaborative approach.

Additionally, in 2015, the 5th edition CPG Management of Diabetes Mellitus Type 2 was issued. The standard of practice especially within the primary health care is greatly guided by the National Clinical Practice Guideline (CPG). The latest CPG puts a greater emphasis in early screening and detection inclusive of mental health issues and patient centered care. With this greater emphasis, it is worthwhile to further examine the effectiveness of the current standard of practice as guided by the latest version of the CPG or whether an add-on psychosocial self-management program to the current practice would yield greater impact.

Significance of study

Based on the National Health Morbidity Survey 2015, the prevalence for diabetes in Putrajaya was reported to be above the national prevalence and at the top half highest prevalence for diabetes (19.2%) as compared to all the states in Malaysia, Moreover, Putrajaya had the highest prevalence for overweight (37%) and abdominal obesity, obesity I, obesity II as well as obesity III (25.8%). Despite that, Putrajaya was found to have the second highest prevalence for adequate health literacy (16%).

Even though the understanding and knowledge on ways to promote and maintain good health was comparably high, prevalence of diabetes and obesity were still at large. This may imply a dissonance between being educated on the illness and the ability to utilize the knowledge to commit to healthy lifestyle changes. Enhancing self-efficacy links this dissonance - that is by improving people's beliefs of their own capabilities to self-manage their diabetes and to produce an impact in their lives.

Therefore, 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. The OHP provides an engagement tool that works as a curative and preventative role for primary health care providers. The OHP is a low-intensity, structured, psychosocial program that emphasizes well-being as compared to illness that is suitable to be given within a primary health care setting .

Specifically, it will be looking at the effectiveness of OHP and treatment-as-usual (TAU) as compared to TAU alone, in improving self-efficacy in patients with diabetes that are currently attending the health clinics within the Putrajaya district. In addition, it will also examine the effectiveness of OHP in improving anxiety, depression, diabetes-related distress, self-care behaviours and glycemic control.

Being tested
Optimal Health Program, Treatment as Usual
Keywords
Well-being, Self-efficacy, Self-management, Psychosocial, Malaysia
Medical subject headings
Diabetes Mellitus, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimal Health ProgramBehavioural

    Also called OHP, Wellbeing Psychosocial 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.

  • Treatment as UsualOther

    Also called TAU

    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.

Study groups in NCT03601884
Study groupRoleWhat they receive
OHP and Treatment as usual (TAU)ExperimentalOptimal 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.
Receives: Behavioral: Optimal Health Program; Other: Treatment as Usual
TAU AloneOtherTreatment-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.
Receives: Other: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 1, Week 5, Week 18, Week 30

  2. 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).

    Measured: Week 1, Week 5, Week 18, Week 30

Secondary outcomes (6)
  1. 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

    Measured: Week 1, Week 5, Week 18, Week 30

  2. 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

    Measured: Week 1, Week 5, Week 18, Week 30

  3. 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.

    Measured: Week 1, Week 5, Week 18, Week 30

  4. 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

    Measured: Week 1, Week 5, Week 18, Week 30

  5. 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

    Measured: Week 1, Week 5, Week 18, Week 30

  6. 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

    Measured: Week 1, Week 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start5 Oct 2018
  3. Primary completion31 Dec 2019
  4. Study completion28 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03601884
Sponsor's protocol ID
OHPMALAYSIA
Acronym
OHP
Status last verified
Apr 2021
First submitted
4 Jul 2018
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32066607

Questions about this trial

What is this clinical trial studying?

A study testing Optimal Health Program and Treatment as Usual in people with Diabetes Mellitus and Chronic Illness, run by Universiti Putra Malaysia at 4 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Diabetes Empowerment Scale (DES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time (time frame: Week 1, Week 5, Week 18, Week 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03601884, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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