Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:52 AM
Study NCT ID:
NCT07486050
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Social Worker Referrals on Diabetes and Loneliness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1C (glycated hemoglobin) level', 'timeFrame': '6 months', 'description': "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.\n\nBaseline 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.\n\nChange 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."}], 'secondaryOutcomes': [{'measure': 'The University of California, Los Angeles (UCLA - 3) score', 'timeFrame': '6 months', 'description': '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.\n\nEach item is scored on a 3-point Likert scale:\n\n1. = Hardly ever\n2. = Some of the time\n3. = Often\n\nThe 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.\n\nA 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabete Mellitus', 'Loneliness']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Ida, S., & Murata, K. (2022). Social Isolation of Older Adults with Diabetes. Gerontology & geriatric medicine, 8, 23337214221116232. https://doi.org/10.1177/23337214221116232'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* Does referral to a social worker reduce feelings of loneliness in older adults with diabetes?\n* Does this support improve blood sugar control (A1C)?\n\nResearchers will compare social worker referral to usual diabetes care to see if this approach improves both social well-being and diabetes outcomes.\n\nParticipants will:\n\n* Be assigned (like flipping a coin) to either meet with a social worker or continue their usual care\n* Complete a short 3-question loneliness survey at the start and again after 6 months\n* Have their A1C levels reviewed from their routine medical records', 'detailedDescription': "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.\n\nPotential 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.\n\nFollowing 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.\n\nIntervention 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.\n\nStudy 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes, lonely\n\nExclusion Criteria:\n\n* Dementia, acute psychiatric or medical illness'}, 'identificationModule': {'nctId': 'NCT07486050', 'briefTitle': 'The Impact of Social Worker Referrals on Diabetes and Loneliness', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'The Impact of Social Worker Referrals on A1C for Seniors With Diabetes Experiencing Loneliness: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '6941'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continue primary care', 'description': 'Continue seeing primary care provider', 'interventionNames': ['Other: Continue Primary care']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Referral to see a social worker', 'interventionNames': ['Behavioral: Social worker referral to address loneliness']}], 'interventions': [{'name': 'Social worker referral to address loneliness', 'type': 'BEHAVIORAL', 'description': 'Patients will be referred to social worker for loneliness management', 'armGroupLabels': ['Intervention arm']}, {'name': 'Continue Primary care', 'type': 'OTHER', 'description': 'Continue seeing primary care', 'armGroupLabels': ['Continue primary care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Rachel Walsh, MD CCFP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'As per research ethic board policy, only result of the study will be disseminated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Physician', 'investigatorFullName': 'Nkechi Ikeaba', 'investigatorAffiliation': 'University of Toronto'}}}}