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

NCT05637437 | Not Yet Recruiting DMC

• 1 other identifier: GS60104
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Elderly; T2DM; HRQoL; Peer Support; Diabetes Management

Outcome Measures

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.

  Baseline, 3rd and 6th month after intervention

Secondary Outcomes (8)

• Diabetes Self-Care Behavior

  Baseline, 3rd and 6th month after intervention

• Social Support

  Baseline, 3rd and 6th month after intervention

• Self-Efficacy

  Baseline, 3rd and 6th month after intervention

• Depression

  Baseline, 3rd and 6th month after intervention

• HbA1c level

  Baseline, 3rd and 6th month after intervention

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: Usual care

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive a peer supported diabetes self-care intervention through digital media

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

Interventions

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.

Intervention Group

Usual care OTHER

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

Control Group; Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Debilitating medical or related condition (e.g. end-stage cancer, severe mental illness)
• Physical inability to provide self-care

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Universiti Putra Malaysia (UPM)

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (12)

• AADE. AADE7 Self-Care Behaviors. Diabetes Educ. 2008 May-Jun;34(3):445-9. doi: 10.1177/0145721708316625. No abstract available.

  PMID: 18535317 BACKGROUND

• Andreae SJ, Andreae LJ, Richman JS, Cherrington AL, Safford MM. Peer-Delivered Cognitive Behavioral Training to Improve Functioning in Patients With Diabetes: A Cluster-Randomized Trial. Ann Fam Med. 2020 Jan;18(1):15-23. doi: 10.1370/afm.2469.

  PMID: 31937528 BACKGROUND

• Castillo-Hernandez KG, Laviada-Molina H, Hernandez-Escalante VM, Molina-Segui F, Mena-Macossay L, Caballero AE. Peer Support Added to Diabetes Education Improves Metabolic Control and Quality of Life in Mayan Adults Living With Type 2 Diabetes: A Randomized Controlled Trial. Can J Diabetes. 2021 Apr;45(3):206-213. doi: 10.1016/j.jcjd.2020.08.107. Epub 2020 Sep 2.

  PMID: 33129754 BACKGROUND

• Ghasemi M, Hosseini H, Sabouhi F. Effect of Peer Group Education on the Quality of Life of Elderly Individuals with Diabetes: A Randomized Clinical Trial. Iran J Nurs Midwifery Res. 2019 Jan-Feb;24(1):44-49. doi: 10.4103/ijnmr.IJNMR_39_17.

  PMID: 30622577 BACKGROUND

• Oluchi SE, Manaf RA, Ismail S, Kadir Shahar H, Mahmud A, Udeani TK. Health Related Quality of Life Measurements for Diabetes: A Systematic Review. Int J Environ Res Public Health. 2021 Sep 1;18(17):9245. doi: 10.3390/ijerph18179245.

  PMID: 34501838 BACKGROUND

• Peimani M, Monjazebi F, Ghodssi-Ghassemabadi R, Nasli-Esfahani E. A peer support intervention in improving glycemic control in patients with type 2 diabetes. Patient Educ Couns. 2018 Mar;101(3):460-466. doi: 10.1016/j.pec.2017.10.007. Epub 2017 Oct 12.

  PMID: 29055655 BACKGROUND

• Sazlina SG, Zaiton A, Nor Afiah MZ, Hayati KS. Predictors of health related quality of life in older people with non-communicable diseases attending three primary care clinics in Malaysia. J Nutr Health Aging. 2012 May;16(5):498-502. doi: 10.1007/s12603-012-0038-8.

  PMID: 22555798 BACKGROUND

• Seah SJ, Zheng H, Lim RBT. Efficacy of community-based self-care interventions to improve biophysical, psychosocial or behavioural outcomes among community-dwelling older adults with type 2 diabetes: A systematic review and meta-analysis. Diabetes Res Clin Pract. 2020 Nov;169:108411. doi: 10.1016/j.diabres.2020.108411. Epub 2020 Sep 6.

  PMID: 32898575 BACKGROUND

• Shahsavari A, Estebsari F, Atashzadeh-Shoorideh F, Ilkhani M. The effect of peer support on quality of life among type 2 diabetic patients in deprived areas in Iran: A randomized clinical trial. J Educ Health Promot. 2021 Sep 30;10:345. doi: 10.4103/jehp.jehp_72_21. eCollection 2021.

  PMID: 34761031 BACKGROUND

• Ahmad Sharoni SK, Abdul Rahman H, Minhat HS, Shariff-Ghazali S, Azman Ong MH. The effects of self-efficacy enhancing program on foot self-care behaviour of older adults with diabetes: A randomised controlled trial in elderly care facility, Peninsular Malaysia. PLoS One. 2018 Mar 13;13(3):e0192417. doi: 10.1371/journal.pone.0192417. eCollection 2018.

  PMID: 29534070 BACKGROUND

• Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Jul 3;15:264. doi: 10.1186/1745-6215-15-264.

  PMID: 24993581 BACKGROUND

• Sinclair A, Saeedi P, Kaundal A, Karuranga S, Malanda B, Williams R. Diabetes and global ageing among 65-99-year-old adults: Findings from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2020 Apr;162:108078. doi: 10.1016/j.diabres.2020.108078. Epub 2020 Feb 14.

  PMID: 32068097 BACKGROUND

Related Links

• Institute for Public Health 2020. National Health and Morbidity Survey (NHMS) 2019: Non-communicable diseases, healthcare demand, and health literacy-Key Findings
• World Health Organization. (2015). World report on ageing and health. World Health Organization.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Prof. Dr Sazlina S Ghazali, MBBS, PhD

  University Putra Malaysia

  STUDY CHAIR

• A/Prof. Cheong Ai Theng, MBBS, PhD

  University Putra Malaysia

  STUDY DIRECTOR

• Segufta Dilshad, EMPH

  University Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Segufta Dilshad, EMPH

CONTACT

+60123081307; gs60104@student.upm.edu.my

Prof. Dr Sazlina S Ghazali, MBBS, PhD

CONTACT

+603-9769 2538; sazlina@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: December 5, 2022
• Study Start: June 1, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)