Skip to content

The Impact of Social Worker Referrals on Diabetes and Loneliness

The Impact of Social Worker Referrals on A1C for Seniors With Diabetes Experiencing Loneliness: A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07486050
Enrollment
90
Registered
2026-03-20
Start date
2026-01-01
Completion date
2026-12-31
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Mellitus, Loneliness

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

Detailed description

This study is a pragmatic, single-centre, parallel-group randomized controlled trial evaluating the integration of social prescribing into primary care for older adults with diabetes who experience loneliness. The intervention is delivered within an academic family health team and leverages existing interprofessional resources to address social determinants of health as part of routine clinical care. Potential participants will be identified through electronic medical record (EMR) queries and clinic-based outreach. Loneliness screening will be conducted using the three-item UCLA Loneliness Scale (UCLA-3), administered via a secure electronic platform (REDCap). A flexible consent process, including both electronic and verbal options, will be used to accommodate varying levels of digital literacy within the target population. Following enrolment, participants will be assigned to study arms using simple randomization (coin toss). The intervention consists of a structured referral to a primary care social worker. The social worker will conduct an initial assessment of the participant's social context, including social supports, barriers to engagement, and unmet practical needs. Based on this assessment, a co-developed plan will be implemented, which may include connection to community resources, facilitation of social engagement activities, and support addressing social or logistical barriers. Follow-up will be individualized in frequency and modality (in-person or virtual), reflecting a pragmatic, patient-centred approach. Intervention delivery will not be protocolized beyond core components, in order to reflect real-world clinical practice. All social worker interactions will be documented within the EMR, allowing for characterization of intervention exposure (e.g., number and type of contacts). Participants in the comparator arm will continue to receive usual diabetes care during the study period, with access to social worker referral after study completion. Study data will be collected through a combination of participant-reported measures and EMR-derived clinical data. Data will be stored in REDCap using unique study identifiers, with linkage files maintained separately on secure, access-restricted servers. Analyses will use regression-based approaches to estimate between-group differences, adjusting for baseline values and relevant covariates. This study is designed to evaluate the feasibility and effectiveness of incorporating social care into chronic disease management within primary care settings. Findings will inform the scalability and implementation of social prescribing interventions aimed at reducing loneliness and improving health outcomes among older adults.

Interventions

BEHAVIORALSocial worker referral to address loneliness

Patients will be referred to social worker for loneliness management

OTHERContinue Primary care

Continue seeing primary care

Sponsors

University of Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Diabetes, lonely

Exclusion criteria

* Dementia, acute psychiatric or medical illness

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1C (glycated hemoglobin) level6 monthsHemoglobin 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.

Secondary

MeasureTime frameDescription
The University of California, Los Angeles (UCLA - 3) score6 monthsThe UCLA 3-item Loneliness Scale (UCLA-3) is a validated, brief self-reported measure used to assess subjective feelings of loneliness and social isolation. It consists of three questions that ask participants how often they experience key aspects of loneliness: (1) lacking companionship, (2) feeling left out, and (3) feeling isolated from others. Each item is scored on a 3-point Likert scale: 1. = Hardly ever 2. = Some of the time 3. = Often The total score ranges from 3 to 9, with higher scores indicating greater perceived loneliness. In this study, the UCLA-3 is administered at baseline and at 6 months electronically via REDCap. A score of ≥5 is used as the threshold to define clinically relevant loneliness for study eligibility. Change in UCLA-3 score over time is used to assess the effect of the intervention, with a reduction in score indicating improvement in perceived loneliness.

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORRachel Walsh, MD CCFP

Sunnybrook Health Sciences Centre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026