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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05637437
• Other study ID #: GS60104
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Universiti Putra Malaysia
• Contact: Segufta Dilshad, EMPH
• Phone: +60123081307
• Email: dilshad.segufta[@]student.upm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• 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.

Other:
• Usual care
Participants in the control group will receive the usual care of the hospital.

Locations

Country	Name	City	State
Malaysia	Universiti Putra Malaysia (UPM)	Serdang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (12)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	3rd month after intervention
Primary	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.	6th month after intervention
Secondary	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.	Baseline
Secondary	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.	3rd month after intervention
Secondary	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.	6th month after intervention
Secondary	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 (a= 0.91 and a=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 (a > 0.91).	Baseline
Secondary	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 (a= 0.91 and a=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 (a > 0.91).	3rd month after intervention
Secondary	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 (a= 0.91 and a=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 (a > 0.91).	6th month after intervention
Secondary	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.	Baseline
Secondary	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.	3rd month after intervention
Secondary	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.	6th month after intervention
Secondary	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.	Baseline
Secondary	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.	3rd month after intervention
Secondary	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.	6th month after intervention
Secondary	HbA1c level	Electronic medical record of the hospital	Baseline
Secondary	HbA1c level	Electronic medical record of the hospital	3rd month after intervention
Secondary	HbA1c level	Electronic medical record of the hospital	6th month after intervention
Secondary	Lipid Profiles	Electronic medical record of the hospital	Baseline
Secondary	Lipid Profiles	Electronic medical record of the hospital	3rd month after intervention
Secondary	Lipid Profiles	Electronic medical record of the hospital	6th month after intervention
Secondary	Body Mass Index	Electronic medical record of the hospital	Baseline
Secondary	Body Mass Index	Electronic medical record of the hospital	3rd month after intervention
Secondary	Body Mass Index	Electronic medical record of the hospital	6th month after intervention
Secondary	Systolic and Diastolic Blood Pressure	Electronic medical record of the hospital	Baseline
Secondary	Systolic and Diastolic Blood Pressure	Electronic medical record of the hospital	3rd month after intervention
Secondary	Systolic and Diastolic Blood Pressure	Electronic medical record of the hospital	6th month after intervention

External 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.