Diabete MellitusNCT07486050
The Impact of Social Worker Referrals on Diabetes and Loneliness
A study testing Social worker referral to address loneliness and Continue Primary care in people with Diabete Mellitus and Loneliness, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabete Mellitus, Loneliness
- What is being tested?
- Social worker referral to address loneliness and Continue Primary care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes, lonely
Who cannot join
- Dementia, acute psychiatric or medical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Social Worker Referrals on A1C for Seniors With Diabetes Experiencing Loneliness: A Randomised Controlled Trial
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:
Read more
- 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
Read the 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.
- Conditions
- Diabete Mellitus, Loneliness
- Being tested
- Social worker referral to address loneliness, Continue Primary care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social worker referral to address lonelinessBehavioural
Patients will be referred to social worker for loneliness management
Continue Primary careOther
Continue seeing primary care
| Study group | Role | What they receive |
|---|---|---|
| Continue primary care | Active comparator | Continue seeing primary care provider Receives: Other: Continue Primary care |
| Intervention arm | Experimental | Referral to see a social worker Receives: Behavioral: Social worker referral to address loneliness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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:
- = Hardly ever
- = Some of the time
- = 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nkechi Ikeaba, University of Toronto
- Investigators
- Rachel Walsh, MD CCFP, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486050
- Sponsor's protocol ID
- 6941
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As per research ethic board policy, only result of the study will be disseminated.
Publications
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.
PubMed 35937276Cho 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.
PubMed 38179980Song 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.
PubMed 37767193Henriksen 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.
PubMed 36168066Kobos 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.
PubMed 32689971
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Social Worker Referrals on A1C for Seniors With Diabetes Experiencing Loneliness: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07486050
- Acronym / sponsor ID
- 6941
- Conditions
- Diabete Mellitus, Loneliness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue primary care | Active comparator | Other: Continue Primary careContinue seeing primary care provider |
| Intervention arm | Experimental | Behavioral: Social worker referral to address lonelinessReferral to see a social worker |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetes, lonely
Key exclusion criteria (1 listed)
- Dementia, acute psychiatric or medical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social worker referral to address lonelinessPatients will be referred to social worker for loneliness management | Behavioural | Intervention arm |
| Continue Primary careContinue seeing primary care | Other | Continue primary care |
Primary outcome
Hemoglobin A1C (glycated hemoglobin) level
Time frame: 6 months
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.
1 secondary outcome
The University of California, Los Angeles (UCLA - 3) score
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 35937276Ida 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.
- Background: PubMed 38179980Cho 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.
- Background: PubMed 37767193Song 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.
- Background: PubMed 36168066Henriksen 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.
- Background: PubMed 32689971Kobos 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.
- Individual participant dataSharing planned: No. As per research ethic board policy, only result of the study will be disseminated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Walsh, MD CCFP principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social worker referral to address loneliness and Continue Primary care in people with Diabete Mellitus and Loneliness, run by University of Toronto at 1 site in Canada.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hemoglobin A1C (glycated hemoglobin) level (time frame: 6 months). 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 NCT07486050, which also lists 5 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 25 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.