跳至主要内容
临床试验/NCT04607915
NCT04607915已完成不适用

Technology-enabled Collaborative Care for Diabetes (TECC-Diabetes) Management During COVID: A Feasibility Study

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Feasibility - Delivery of Intervention (Time with coach)

研究概览

简要总结

The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for type 2 diabetes designed to support patients with diabetes and mental health concerns during COVID-19.

详细描述

There is growing concern regarding the impact of COVID-19 and social isolation on mental health and wellbeing, particularly adults living with type 2 diabetes (T2DM), who are at greater risk for mental health issues than the general population. Self-management education and support for healthy eating, physical activity, glucose monitoring, medication adherence and problem solving are vital components of diabetes care. Due to social distancing and limited care and resources, that are likely to persist in the post pandemic phase other innovative service models should be developed and adopted to improve service delivery. The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for T2DM designed to support patients with diabetes and mental health concerns during COVID-19.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Age: 18 years and older
  • Clinician diagnosis of Type 2 diabetes for at least one year
  • A1C level of 7.5% or higher within the last 6 months (benchmark is 7%)
  • Access to telephone or internet through computer or mobile
  • Experiencing some distress, score of ** on Perceived Stress Scale

排除标准

  • Unable to provide consent
  • Unable to understand English
  • Pregnant or planning to get pregnant during the course of the study

结局指标

主要结局

Feasibility - Delivery of Intervention (Time with coach)

时间窗: up to 8-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes the amount of time a coach spends per interaction

Feasibility - Recruitment Numbers

时间窗: Through the study completion, an average of 4 months

The primary outcome in this study is feasibility, specifically process outcomes. This includes assessing recruitment number

Feasibility - Delivery of Intervention (Coach strategies)

时间窗: up to 12-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes what strategies are used by the coach (i.e., educational, psychosocial support, behaviour modifications, or case management/monitoring)

Feasibility - Participant characteristics

时间窗: up to 8-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics

Feasibility - Participant Engagement (retention rate)

时间窗: up to 8-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes participant retention rate (e.g., defined by time between first and last visit)

Feasibility - Delivery of Intervention (Mode of interaction)

时间窗: up to 12-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes the mode of the interaction (i.e., virtual, telephone or both)

Feasibility - Participant Engagement (intensity)

时间窗: up to 8-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes intensity (e.g., number of session participants attend)

Feasibility - Participant Engagement (drop out)

时间窗: up to 8-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes drop out (consented/enrolled but did not attend first one-on-one)

次要结局

  • Study Participant experience and satisfaction via semi-structured interview(up to 8-weeks)
  • Virtual Care Team experience and satisfaction via semi-structured interview(up to 8-weeks)
  • Care Coordinator experience and satisfaction via semi-structured interview(up to 8-weeks)

研究者

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

Peter Selby

Clinician Scientist

Centre for Addiction and Mental Health

研究点 (2)

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