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临床试验/NCT05668507
NCT05668507进行中(未招募)不适用

Using a Virtual Care Platform to Deliver Peer-led Mental Health Support to Rural and Remote Communities in BC: a Randomized Wait-list Controlled Trial of the REACHOUT Intervention

University of British Columbia1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2024年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
225
试验地点
1
主要终点
Change in Diabetes Distress

研究概览

简要总结

The purpose of this study is to investigate the effectiveness of participation in a 6-month peer-led mental health support program, delivered via a mobile app (REACHOUT), to adults with type 1 diabetes compared to a wait-list control condition. Participants will connect with a Peer-Supporter (an adult with type 1 diabetes trained in providing mental health support), and have access to the app features including a 24/7 chat room and face-to-face support delivered via virtual happy hours.

详细描述

REACHOUT is a mobile app which delivers peer-led mental health support to adults with type 1 diabetes. The mobile app has three support features:

  1. One-on-one support delivered by a Peer Supporter

Peer Supporters are adults with type 1 diabetes who will be trained on providing support to other adults with type 1 diabetes on the app ("the participants"). Participants will be able to go through the peer supporter library, review their profiles, and choose their peer supporter. 2. Group support delivered via a 24/7 chat room

Peer Supporters and participants on the app will be able to chat 24/7 in the chat room about any topic ranging from feedback on new devices to traveling with diabetes. The chat room is monitored by healthcare professionals including a registered nurse and registered psychologist. 3. Face to face support delivered via virtual happy hours

Virtual happy hours are educational presentations/discussions led by either a Peer Supporter or healthcare professional on topics related to diabetes.

研究设计

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

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •have type 1 diabetes (T1D)
  • •be 19 years or older
  • •reside in one of the targeted health authorities in British Columbia (Fraser Health, Island Health, Northern Health, and Interior Health Authorities)
  • •be English proficient
  • •have an average diabetes distress (DD) Subscale Score ≥ 2
  • •have access to the internet and/or a smartphone.

排除标准

  • •Participants with a pre-existing mental health condition, multiple co-morbidities, substance use challenges, and or any other condition that may prevent meaningful participation may not participate in this study.

研究组 & 干预措施

REACHOUT

Experimental

The REACHOUT intervention arm will receive access to the REACHOUT mobile app through which they will be able to review profiles of Peer Supporters and connect with one of their choosing. They will also have access to the other app features including a 24/7 chat room and face-to-face support via virtual happy hours. Participants will complete questionnaires (baseline, 1 month, 3 months, 6 months) and a blood draw (baseline and 6 months). Monetary compensation will be provided for their time and effort.

干预措施: REACHOUT Virtual Mental Health Support (Behavioral)

Wait-list

No Intervention

The wait-list control group will receive access to the mobile app/support program after six (6) months. They will complete questionnaires and a blood draw at baseline and 6 months. Monetary compensation will be provided for their time and effort.

结局指标

主要结局

Change in Diabetes Distress

时间窗: 0, 6 month(s)

Diabetes Distress will be measured by the Type 1 Diabetes Distress Scale (T1D-DDS). This scale contains 28 items that people with type 1 diabetes may find distressing. Participants rate each item on a scale from 1 indicating Not a Problem to 6 indicating a Very Serious Problem. There are seven subscales including powerlessness, management distress, hypoglycemia distress, negative social distress, eating distress, physician distress, and family/friends distress. Overall and subscale scores are calculated by taking the mean of items in the overall or subscale. A higher score indicates higher diabetes distress.

次要结局

  • Change in Depressive Symptom Severity(0, 6 month(s))
  • Change in Perceived social support(0, 6 month(s))
  • Change in Resilience(0, 6 month(s))
  • Change in Diabetes-Specific Quality of Life(0, 6 month(s))
  • Change in Health-Related Quality of Life(0, 3, 6 month(s))
  • Change in Quality Adjusted Life year (QALY)(0, 3, 6 month(s))
  • Change in Health Related Costs(0, 3, 6 month(s))
  • Change in Hemoglobin A1c(0, 6 month(s))
  • Change in % Time in Range(14 days before and after each participant's baseline and 6-month assessments, respectively)

研究者

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

Tricia Tang

Principal Investigator

University of British Columbia

研究点 (1)

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