Peer-Supported Diabetes Self-Care Intervention to Improve Health Related Quality of Life (HRQoL) and Diabetes Management
NCT ID: NCT05637437
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
128 participants
INTERVENTIONAL
2025-06-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control Group
Participants in the control group will receive the usual care of the hospital.
Usual care
Participants in the control group will receive the usual care of the hospital.
Intervention Group
Participants in the intervention group will receive a peer supported diabetes self-care intervention through digital media
Peer supported diabetes self-care intervention
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
Participants in the control group will receive the usual care of the hospital.
Interventions
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Peer supported diabetes self-care intervention
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
Participants in the control group will receive the usual care of the hospital.
Eligibility Criteria
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Inclusion Criteria
* 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
* Physical inability to provide self-care
60 Years
ALL
Yes
Sponsors
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Universiti Putra Malaysia
OTHER
Responsible Party
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Segufta Dilshad
Principal Investigator
Principal Investigators
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Prof. Dr Sazlina S Ghazali, MBBS, PhD
Role: STUDY_CHAIR
University Putra Malaysia
A/Prof. Cheong Ai Theng, MBBS, PhD
Role: STUDY_DIRECTOR
University Putra Malaysia
Segufta Dilshad, EMPH
Role: PRINCIPAL_INVESTIGATOR
University Putra Malaysia
Locations
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Universiti Putra Malaysia (UPM)
Serdang, Selangor, Malaysia
Countries
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Central Contacts
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References
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AADE. AADE7 Self-Care Behaviors. Diabetes Educ. 2008 May-Jun;34(3):445-9. doi: 10.1177/0145721708316625. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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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.
Other Identifiers
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GS60104
Identifier Type: -
Identifier Source: org_study_id
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