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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continue primary care | Active Comparator | Continue seeing primary care provider |
|
| Intervention arm | Experimental | Referral to see a social worker |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social worker referral to address loneliness | Behavioral | Patients will be referred to social worker for loneliness management |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The University of California, Los Angeles (UCLA - 3) score | The 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:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Walsh, MD CCFP | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35937276 | Background | Ida S, Murata K. Social Isolation of Older Adults With Diabetes. Gerontol Geriatr Med. 2022 Aug 2;8:23337214221116232. doi: 10.1177/23337214221116232. eCollection 2022 Jan-Dec. | |
| 38179980 | Background | Cho E, Kim J, Bang S. Loneliness in older adults with diabetes mellitus: a scoping review. Psychol Health Med. 2024 Sep;29(8):1548-1563. doi: 10.1080/13548506.2023.2299665. Epub 2024 Jan 5. |
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As per research ethic board policy, only result of the study will be disseminated.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Continue Primary care | Other | Continue seeing primary care |
|
| 6 months |
| 37767193 | 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 JE, Dou K. Social isolation, loneliness, and incident type 2 diabetes mellitus: results from two large prospective cohorts in Europe and East Asia and Mendelian randomization. EClinicalMedicine. 2023 Sep 21;64:102236. doi: 10.1016/j.eclinm.2023.102236. eCollection 2023 Oct. |
| 36168066 | Background | Henriksen RE, Nilsen RM, Strandberg RB. Loneliness increases the risk of type 2 diabetes: a 20 year follow-up - results from the HUNT study. Diabetologia. 2023 Jan;66(1):82-92. doi: 10.1007/s00125-022-05791-6. Epub 2022 Sep 28. |
| 32689971 | Background | Kobos E, Szewczyk A, Swiatkowska T, Kryczka T, Sienkiewicz Z. Relationship between loneliness and blood glucose control in diabetes. BMC Public Health. 2020 Jul 20;20(1):1140. doi: 10.1186/s12889-020-09241-z. |