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Type 2 Diabetes MellitusNCT05637437

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

A study testing Peer supported diabetes self-care intervention in people with Type 2 Diabetes Mellitus, run by Universiti Putra Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Peer supported diabetes self-care intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteMalaysia
Study dates
14 Jul 2025to 28 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Universiti Putra Malaysia (UPM)

    Serdang, Selangor, 43400

Other trials in Malaysia

About this study

Official title: Peer-Supported Diabetes Self-Care Intervention to Improve Health-Related Quality of Life (HRQoL) and Diabetes Management in the Elderly With Type 2 Diabetes (T2DM): A Randomized Controlled 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.

Read the 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.

Being tested
Peer supported diabetes self-care intervention, Usual care
Keywords
Elderly, T2DM, HRQoL, Peer Support, Diabetes Management
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer supported diabetes self-care interventionBehavioural

    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 careOther

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

Study groups in NCT05637437
Study groupRoleWhat they receive
Control GroupActive comparatorParticipants in the control group will receive the usual care of the hospital.
Receives: Other: Usual care
Intervention GroupExperimentalParticipants in the intervention group will receive a peer supported diabetes self-care intervention through digital media
Receives: Behavioral: Peer supported diabetes self-care intervention; Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 3rd and 6th month after intervention

Secondary outcomes (8)

  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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: Baseline, 3rd and 6th month after intervention

  5. HbA1c level

    Electronic medical record of the hospital

    Measured: Baseline, 3rd and 6th month after intervention

  6. Lipid Profiles

    Electronic medical record of the hospital

    Measured: Baseline, 3rd and 6th month after intervention

  7. Body Mass Index

    Electronic medical record of the hospital

    Measured: Baseline, 3rd and 6th month after intervention

  8. Systolic and Diastolic Blood Pressure

    Electronic medical record of the hospital

    Measured: Baseline, 3rd and 6th month after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2022
  2. Study start14 Jul 2025
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05637437
Sponsor's protocol ID
GS60104
Status last verified
Aug 2026
First submitted
12 Nov 2022
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 18535317

  • 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.

    PubMed 31937528

  • 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.

    PubMed 33129754

  • 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.

    PubMed 30622577

  • 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.

    PubMed 34501838

  • 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.

    PubMed 29055655

  • 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.

    PubMed 22555798

  • 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.

    PubMed 32898575

  • 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.

    PubMed 34761031

  • 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.

    PubMed 29534070

  • 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.

    PubMed 24993581

  • 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.

    PubMed 32068097

Questions about this trial

What is this clinical trial studying?

A study testing Peer supported diabetes self-care intervention in people with Type 2 Diabetes Mellitus, run by Universiti Putra Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Related Quality of Life (time frame: Baseline, 3rd and 6th month after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05637437, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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