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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversiti Putra Malaysia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Debilitating medical or related condition (e.g. end-stage cancer, severe mental illness)

Physical inability to provide self-care

Trial design

Design model

Parallel

Treatments tested in this trial

  • Peer supported diabetes self-care intervention

    Behavioral

    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.

  • Usual care

    Other intervention

    Participants in the control group will receive the usual care of the hospital.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 3rd and 6th month after intervention

Secondary outcomes

1

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.

Time frame
Baseline, 3rd and 6th month after intervention
2

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).

Time frame
Baseline, 3rd and 6th month after intervention
3

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.

Time frame
Baseline, 3rd and 6th month after intervention
4

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.

Time frame
Baseline, 3rd and 6th month after intervention

Other outcomes

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