Peer-Supported Diabetes Self-Care Intervention to Improve Health Related Quality of Life (HRQoL) and Diabetes Management

Study Overview
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Brief Summary
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Diabetes mellitus is the ninth leading cause of mortality worldwide. Diabetes is a chronic condition with a major impact on the life and well-being of individuals, families, and societies globally. The three main types of diabetes are type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM), and gestational diabetes mellitus (GDM); approximately 90% of the total cases accounts for T2DM. T2DM is characterized by chronic hyperglycaemia and affects 9.5% of adults aged 20-99 years. The highly burdensome condition is predominantly prevalent in elderly population and distresses 19.3% of elderly aged 65-99 years. Elderly with diabetes have poor Health related Quality of Life (HRQoL) in comparison with their peers of similar age from the general populations. The determinants of poor HRQoL in elderly with T2DM diabetes population are - poor glycemic control, long duration of diabetes, multiple co-morbidities, depression, high body mass index (BMI), poor self-management practices, higher diabetes related distress, low social support and increased social isolation. Diabetes Self-management Education and Support (DSME/S) is a critical element of care to improve the overall condition of diabetic patients. Self-care does play a critical role in elderly diabetes management. The goal of the current clinical trial is to develop and assess the effectiveness of peer supported diabetes self-care intervention in improving the HRQoL in elderly with type 2 diabetes.

Detailed Description
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Currently, the prevalence of elderly T2DM in Malaysia is 27.7% compared to 22.7% of 2010. Clinical outcome of diabetes management found deteriorating glycemic control, the mean HbA1c for 2013-2019 ranged from 7.9% - 8.1% and 30.7% of patients achieved the Ministry of Health Diabetes Quality Assurance (QA) target of HbA1c ≤6.5% in 2020. The higher blood sugar level results diabetes complications (cataract 27.2%, neuropathy 45.9% and angina pectoris 18.4%) and poor health related quality of life. Interventions incorporating the cultural, psychosocial, and behavioural factors could improve biophysical, clinical and self-care related outcomes for the elderly with T2DM. People with diabetes require additional resources and support to facilitate and achieve better diabetes HRQoL; and although social and emotional support can occur through family and friends, most people require additional supports from peers. Peer support refers to the provision of emotional, appraisal and informational support from people who have experiential knowledge of a condition and this support functions to complement, supplement and extend formal primary care services. There is lack of evidence observed on peer supported self-care intervention using 'digital media for the elderly population with T2DM' including appropriate theoretical framework, adequate methodological/designing guidelines and non-pharmacological intervention guideline to improve HRQoL and psychosocial, biomedical and anthropometric outcomes in a single intervention.

Official Title
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Peer-Supported Diabetes Self-Care Intervention to Improve Health Related Quality of Life (HRQoL) and Diabetes Management in Elderly With Type 2 Diabetes (T2DM): A Randomized Control Trial

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Peer supported diabetes self-care intervention
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age must be 60 years or more Diagnosed with T2DM by physician minimum for more than 1 year The ability to communicate in Malay or English language properly The ability to perform daily activities independently No major complications (e.g.- dementia, blind, deaf) Planned to continue receiving care at this clinic for next 6 months Participated at the usual education session Access to a smart phone with internet Exclusion Criteria: Debilitating medical or related condition (e.g. end-stage cancer, severe mental illness) Physical inability to provide self-care

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Participants in the control group will receive the usual care of the hospital. | Other: Usual care<br>* Participants in the control group will receive the usual care of the hospital.<br>|
| Experimental: Intervention Group<br>Participants in the intervention group will receive a peer supported diabetes self-care intervention through digital media | Behavioral: Peer supported diabetes self-care intervention<br>* Participants in the intervention group will attend a multi-faceted 8 weeks peer supported diabetes self-care intervention through digital communication. Weekly group video telephony meeting facilitated by trained peer supporters. Support and assistance through instant messaging services between peer supporters and participants.<br>Other: Usual care<br>* Participants in the control group will receive the usual care of the hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life | The HRQoL will be measured by the Revised Version of Diabetes Quality of Life Questionnaire (Bujang et al., 2018). The scale has demonstrated good reliability, composite reliability for each domain was computed as well; satisfaction domain showed highest composite reliability of 0.922, followed by worry domain (0.794) and impact domain (0.781). The range of score for each item is 1 to 5 and total score for the scale is 13 - 65, where higher score indicates poorer quality of life. | Baseline | 
| Health Related Quality of Life | The HRQoL will be measured by the Revised Version of Diabetes Quality of Life Questionnaire (Bujang et al., 2018). The scale has demonstrated good reliability, composite reliability for each domain was computed as well; satisfaction domain showed highest composite reliability of 0.922, followed by worry domain (0.794) and impact domain (0.781). The range of score for each item is 1 to 5 and total score for the scale is 13 - 65, where higher score indicates poorer quality of life. | 3rd month after intervention | 
| Health Related Quality of Life | The HRQoL will be measured by the Revised Version of Diabetes Quality of Life Questionnaire (Bujang et al., 2018). The scale has demonstrated good reliability, composite reliability for each domain was computed as well; satisfaction domain showed highest composite reliability of 0.922, followed by worry domain (0.794) and impact domain (0.781). The range of score for each item is 1 to 5 and total score for the scale is 13 - 65, where higher score indicates poorer quality of life. | 6th month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Self-Care Behavior | The Summary of Diabetes Self-Care Activities Scale (Toobert & Glasgow, 1994; Bujang et al., 2016), a 11-item questionnaire measures the frequency of completing different self-care regimen activities over the preceding seven days. All items validated and reliability tested except for smoking status which is in dichotomous response (no/yes). For scoring, general diet = mean number of days for items 1 and 2; specific diet = mean number of days for items 3, and 4, reversing item 4 (0=7, 1=6, 2=5, 3=4, 4=3, 5=2, 6=1, 7=0). Given the low inter-item correlations for this scale, using the individual items is recommended. Exercise = Mean number of days for items 5 and 6; Blood-Glucose Testing = Mean number of days for items 7 and 8; Foot-Care = Mean number of days for items 9 and 10; Smoking Status = Item 11 (0 = non-smoker, 1 = smoker), and number of cigarettes smoked per day. | Baseline | 
| Diabetes Self-Care Behavior | The Summary of Diabetes Self-Care Activities Scale (Toobert & Glasgow, 1994; Bujang et al., 2016), a 11-item questionnaire measures the frequency of completing different self-care regimen activities over the preceding seven days. All items validated and reliability tested except for smoking status which is in dichotomous response (no/yes). For scoring, general diet = mean number of days for items 1 and 2; specific diet = mean number of days for items 3, and 4, reversing item 4 (0=7, 1=6, 2=5, 3=4, 4=3, 5=2, 6=1, 7=0). Given the low inter-item correlations for this scale, using the individual items is recommended. Exercise = Mean number of days for items 5 and 6; Blood-Glucose Testing = Mean number of days for items 7 and 8; Foot-Care = Mean number of days for items 9 and 10; Smoking Status = Item 11 (0 = non-smoker, 1 = smoker), and number of cigarettes smoked per day. | 3rd month after intervention | 
| Diabetes Self-Care Behavior | The Summary of Diabetes Self-Care Activities Scale (Toobert & Glasgow, 1994; Bujang et al., 2016), a 11-item questionnaire measures the frequency of completing different self-care regimen activities over the preceding seven days. All items validated and reliability tested except for smoking status which is in dichotomous response (no/yes). For scoring, general diet = mean number of days for items 1 and 2; specific diet = mean number of days for items 3, and 4, reversing item 4 (0=7, 1=6, 2=5, 3=4, 4=3, 5=2, 6=1, 7=0). Given the low inter-item correlations for this scale, using the individual items is recommended. Exercise = Mean number of days for items 5 and 6; Blood-Glucose Testing = Mean number of days for items 7 and 8; Foot-Care = Mean number of days for items 9 and 10; Smoking Status = Item 11 (0 = non-smoker, 1 = smoker), and number of cigarettes smoked per day. | 6th month after intervention | 
| Social Support | Social Support will be measured using the Malay version of Medical Outcomes Study Social Support Survey, which consists of four dimensions/subscales (emotional, tangible support, positive social interaction and affectionate support) and 19 items (Norhayati et al., 2015). Both the English and the Malay versions has good reliability (α= 0.91 and α=0.96 respectively). Responses were summed to create a total score ranging from 0 to 100, with the higher score indicating greater outcome expectations. Scores were rescaled to a 0 to 100 on a ratio scale, with higher scores indicating a higher social support. The original instrument showed acceptable reliability (α > 0.91). | Baseline | 
| Social Support | Social Support will be measured using the Malay version of Medical Outcomes Study Social Support Survey, which consists of four dimensions/subscales (emotional, tangible support, positive social interaction and affectionate support) and 19 items (Norhayati et al., 2015). Both the English and the Malay versions has good reliability (α= 0.91 and α=0.96 respectively). Responses were summed to create a total score ranging from 0 to 100, with the higher score indicating greater outcome expectations. Scores were rescaled to a 0 to 100 on a ratio scale, with higher scores indicating a higher social support. The original instrument showed acceptable reliability (α > 0.91). | 3rd month after intervention | 
| Social Support | Social Support will be measured using the Malay version of Medical Outcomes Study Social Support Survey, which consists of four dimensions/subscales (emotional, tangible support, positive social interaction and affectionate support) and 19 items (Norhayati et al., 2015). Both the English and the Malay versions has good reliability (α= 0.91 and α=0.96 respectively). Responses were summed to create a total score ranging from 0 to 100, with the higher score indicating greater outcome expectations. Scores were rescaled to a 0 to 100 on a ratio scale, with higher scores indicating a higher social support. The original instrument showed acceptable reliability (α > 0.91). | 6th month after intervention | 
| Self-Efficacy | Self-efficacy will be measured by the the Diabetes Empowerment Scale, which is a 8-item short form of questionnaire, measures the psychosocial self-efficacy of people with diabetes (Anderson et al., 2003) and evaluate the empowerment levels of individuals in relation to their state of health. The result of the scale obtains by the average of the sum of all included items, in which higher values are related to higher perceptions of psychosocial self-efficacy. The coefficient of Cronbach's alpha of 0.84 was obtained and the unidimensional nature of the scale was confirmed. | Baseline | 
| Self-Efficacy | Self-efficacy will be measured by the the Diabetes Empowerment Scale, which is a 8-item short form of questionnaire, measures the psychosocial self-efficacy of people with diabetes (Anderson et al., 2003) and evaluate the empowerment levels of individuals in relation to their state of health. The result of the scale obtains by the average of the sum of all included items, in which higher values are related to higher perceptions of psychosocial self-efficacy. The coefficient of Cronbach's alpha of 0.84 was obtained and the unidimensional nature of the scale was confirmed. | 3rd month after intervention | 
| Self-Efficacy | Self-efficacy will be measured by the the Diabetes Empowerment Scale, which is a 8-item short form of questionnaire, measures the psychosocial self-efficacy of people with diabetes (Anderson et al., 2003) and evaluate the empowerment levels of individuals in relation to their state of health. The result of the scale obtains by the average of the sum of all included items, in which higher values are related to higher perceptions of psychosocial self-efficacy. The coefficient of Cronbach's alpha of 0.84 was obtained and the unidimensional nature of the scale was confirmed. | 6th month after intervention | 
| Depression | The Malay Version Brief Patient Health Questionnaire (Shaaban, 2005) is a 9-item depression scale measures the level of depression. Each question has scale from 0-3 reflecting the severity of the symptoms. The possible total score ranges from 0-27. The total score greater than 10 had a sensitivity and specificity of 88% for major depressive disorder. Reliability and validity of the scale has indicated a sound psychometric property with high internal consistency. Scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. | Baseline | 
| Depression | The Malay Version Brief Patient Health Questionnaire (Shaaban, 2005) is a 9-item depression scale measures the level of depression. Each question has scale from 0-3 reflecting the severity of the symptoms. The possible total score ranges from 0-27. The total score greater than 10 had a sensitivity and specificity of 88% for major depressive disorder. Reliability and validity of the scale has indicated a sound psychometric property with high internal consistency. Scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. | 3rd month after intervention | 
| Depression | The Malay Version Brief Patient Health Questionnaire (Shaaban, 2005) is a 9-item depression scale measures the level of depression. Each question has scale from 0-3 reflecting the severity of the symptoms. The possible total score ranges from 0-27. The total score greater than 10 had a sensitivity and specificity of 88% for major depressive disorder. Reliability and validity of the scale has indicated a sound psychometric property with high internal consistency. Scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. | 6th month after intervention | 
| HbA1c level | Electronic medical record of the hospital | Baseline | 
| HbA1c level | Electronic medical record of the hospital | 3rd month after intervention | 
| HbA1c level | Electronic medical record of the hospital | 6th month after intervention | 
| Lipid Profiles | Electronic medical record of the hospital | Baseline | 
| Lipid Profiles | Electronic medical record of the hospital | 3rd month after intervention | 
| Lipid Profiles | Electronic medical record of the hospital | 6th month after intervention | 
| Body Mass Index | Electronic medical record of the hospital | Baseline | 
| Body Mass Index | Electronic medical record of the hospital | 3rd month after intervention | 
| Body Mass Index | Electronic medical record of the hospital | 6th month after intervention | 
| Systolic and Diastolic Blood Pressure | Electronic medical record of the hospital | Baseline | 
| Systolic and Diastolic Blood Pressure | Electronic medical record of the hospital | 3rd month after intervention | 
| Systolic and Diastolic Blood Pressure | Electronic medical record of the hospital | 6th month after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Media, Elderly, T2DM, HRQoL, Peer Support