Clinical trial NCT05637437: Peer-Supported Diabetes Self-Care Intervention to Improve Health Related Quality of Life (HRQoL) and Diabetes Management
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Elderly
T2DM
HRQoL
Peer Support
Diabetes Management
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 128
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Health Related Quality of Life
timeFrame: Baseline, 3rd and 6th month after intervention
Secondary outcomes:
measure: Diabetes Self-Care Behavior
timeFrame: Baseline, 3rd and 6th month after intervention
measure: Social Support
timeFrame: Baseline, 3rd and 6th month after intervention
measure: Self-Efficacy
timeFrame: Baseline, 3rd and 6th month after intervention
measure: Depression
timeFrame: Baseline, 3rd and 6th month after intervention
measure: HbA1c level
timeFrame: Baseline, 3rd and 6th month after intervention
measure: Lipid Profiles
timeFrame: Baseline, 3rd and 6th month after intervention
measure: Body Mass Index
timeFrame: Baseline, 3rd and 6th month after intervention
measure: Systolic and Diastolic Blood Pressure
timeFrame: Baseline, 3rd and 6th month after intervention
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia (UPM)
state: Selangor
Study officials:
affiliation: University Putra Malaysia
name: Prof. Dr Sazlina S Ghazali, MBBS, PhD
role: STUDY_CHAIR
affiliation: University Putra Malaysia
name: A/Prof. Cheong Ai Theng, MBBS, PhD
role: STUDY_DIRECTOR
affiliation: University Putra Malaysia
name: Segufta Dilshad, EMPH
role: PRINCIPAL_INVESTIGATOR
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