跳至主要内容
临床试验/NCT07486050
NCT07486050Enrolling By Invitation不适用

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

University of Toronto1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
90
试验地点
1
主要终点
Hemoglobin A1C (glycated hemoglobin) level

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Diabetes, lonely

排除标准

  • Dementia, acute psychiatric or medical illness

结局指标

主要结局

Hemoglobin A1C (glycated hemoglobin) level

时间窗: 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.

次要结局

  • The University of California, Los Angeles (UCLA - 3) score(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nkechi Ikeaba

Resident Physician

University of Toronto

研究点 (1)

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