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

U

University of Putra Malaysia (UPM)

Status

Not yet enrolling

Conditions

Type 2 Diabetes Mellitus

Treatments

Other: Usual care
Behavioral: Peer supported diabetes self-care intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05637437
GS60104

Details and patient eligibility

About

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.

Full 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.

Enrollment

128 estimated patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

128 participants in 2 patient groups

Control Group
Active Comparator group
Description:
Participants in the control group will receive the usual care of the hospital.
Treatment:
Other: Usual care
Intervention Group
Experimental group
Description:
Participants in the intervention group will receive a peer supported diabetes self-care intervention through digital media
Treatment:
Behavioral: Peer supported diabetes self-care intervention
Other: Usual care

Trial contacts and locations

1

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Central trial contact

Prof. Dr Sazlina S Ghazali, MBBS, PhD; Segufta Dilshad, EMPH

Data sourced from clinicaltrials.gov

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