Effectiveness of OHP in Improving Self-efficacy in Patients With Diabetes Mellitus
Condition: Diabetes Mellitus; Chronic Illness
MeSH terms: Diabetes Mellitus; Chronic Disease
Study type: Interventional

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.
    

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.
    

Intervention name(s): Optimal Health Program; Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): 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-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 intervention name(s): OHP; Wellbeing Psychosocial Program; TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant)
Primary purpose: Treatment
Keywords: Well-being; Self-efficacy; Self-management; Psychosocial; Malaysia