The Impact of Social Worker Referrals on Diabetes and Loneliness

NCT07486050 | Active Not Recruiting

• 1 other identifier: 6941
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if referral to a social worker (social prescribing) can help reduce loneliness and improve blood sugar control (A1C) in older adults with diabetes. It will also help us understand how this approach can support overall well-being in seniors. The main questions it aims to answer are:

• Does referral to a social worker reduce feelings of loneliness in older adults with diabetes?
• Does this support improve blood sugar control (A1C)? Researchers will compare social worker referral to usual diabetes care to see if this approach improves both social well-being and diabetes outcomes. Participants will:
• Be assigned (like flipping a coin) to either meet with a social worker or continue their usual care
• Complete a short 3-question loneliness survey at the start and again after 6 months
• Have their A1C levels reviewed from their routine medical records

Conditions

Diabete Mellitus; Loneliness

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C (glycated hemoglobin) level

  Hemoglobin A1C (glycated hemoglobin) is a routinely used laboratory measure that reflects average blood glucose levels over the preceding 3 months. In this study, A1C values will be obtained from participants' electronic medical records (EMR) as part of routine clinical care; no additional blood draws will be required for research purposes. Baseline A1C will be defined as the most recent value within ±4 weeks of enrolment. Follow-up A1C will be the value obtained closest to 6 months after enrolment, within routine clinical testing intervals. A1C is reported as a percentage (%), with higher values indicating poorer glycemic control. Change in A1C from baseline to 6 months will be used to assess the effect of the intervention on glycemic control. The secondary analysis will adjust for baseline A1C and relevant clinical factors, including medication changes where applicable.

  6 months

Secondary Outcomes (1)

• The University of California, Los Angeles (UCLA - 3) score

  6 months

Study Arms (2)

Continue primary care

ACTIVE COMPARATOR

Continue seeing primary care provider

Other: Continue Primary care

Intervention arm

EXPERIMENTAL

Referral to see a social worker

Behavioral: Social worker referral to address loneliness

Interventions

Social worker referral to address loneliness BEHAVIORAL

Patients will be referred to social worker for loneliness management

Intervention arm

Continue Primary care OTHER

Continue seeing primary care

Continue primary care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes, lonely

You may not qualify if:

• Dementia, acute psychiatric or medical illness

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (5)

• Ida, S., & Murata, K. (2022). Social Isolation of Older Adults with Diabetes. Gerontology & geriatric medicine, 8, 23337214221116232. https://doi.org/10.1177/23337214221116232

  BACKGROUND

• Cho, E., Kim, J., & Bang, S. (2024). Loneliness in older adults with diabetes mellitus: a scoping review. Psychology, health & medicine, 29(8), 1548-1563. https://doi.org/10.1080/13548506.2023.2299665

  BACKGROUND

• Song, Y., Zhu, C., Shi, B., Song, C., Cui, K., Chang, Z., Gao, G., Jia, L., Fu, R., Dong, Q., Feng, L., Zhu, C., Yin, D., Manson, J. E., & Dou, K. (2023). Social isolation, loneliness, and incident type 2 diabetes mellitus: results from two large prospective cohorts in Europe and East Asia and Mendelian randomization. EClinicalMedicine, 64, 102236. https://doi.org/10.1016/j.eclinm.2023.102236

  BACKGROUND

• Henriksen, R. E., Nilsen, R. M., & Strandberg, R. B. (2023). Loneliness increases the risk of type 2 diabetes: a 20-year follow-up - results from the HUNT study. Diabetologia, 66(1), 82-92.

  BACKGROUND

• Kobos, E., Szewczyk, A., Świątkowska, T., Kryczka, T., & Sienkiewicz, Z. (2020). Relationship between loneliness and blood glucose control in diabetes. BMC public health, 20(1), 1140. https://doi.org/10.1186/s12889-020-09241-z

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Rachel Walsh, MD CCFP

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)