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临床试验/NCT05006391
NCT05006391已完成不适用

Tele-Coaching CBE Study: Evaluating the Implementation of an Online Community-Based Exercise (CBE) Intervention Using Tele-Coaching to Enhance Physical Activity Among Adults Living With HIV

University of Toronto2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年5月17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
33
试验地点
2
主要终点
Physical Activity

研究概览

简要总结

The primary aim of this research is to evaluate the implementation of an online tele-coaching community-based exercise (CBE) intervention with adults living with HIV.

详细描述

Investigators will use the RE-AIM (Reach-Effectiveness-Adoption-Implementation-Maintenance) Framework to evaluate the tele-coaching CBE intervention. The RE-AIM Framework includes criteria to evaluate the impact and translation of an intervention at both individual and organizational levels in order to promote uptake, transferability and ultimate enhance the impact of health promotion interventions.

Specific study objectives are: 1) To determine the extent (proportion of sessions attended, frequency, intensity, time, type) to which adults living with HIV participate in the intervention (Reach); 2) To assess the impact of the intervention on physical activity, health, and engagement in the care cascade (Effectiveness); 3) To assess engagement in exercise for adults living with HIV over time (physical activity, adherence) (Maintenance); and 4) To evaluate the a) process (strengths, challenges, accessibility, cost, fidelity) and b) feasibility of sustainability of the implementation, from the perspective of adults living with HIV, representatives of community-based organizations (CBOs), health and fitness centres, health providers, and policy stakeholders to build capacity, products, and considerations for broader implementation (Implementation and Adoption).

Investigators will conduct a prospective longitudinal mixed methods intervention study to evaluate the implementation of an innovative online tele-coaching CBE intervention with adults living with HIV. They will use a combination of quantitative (self-reported questionnaires, fitness assessments) to assess outcomes bimonthly during the tele-coaching CBE intervention (6 months) and during a follow-up monitoring phase (6 months) to evaluate the short and long term impact of online CBE. Investigators will use a qualitative longitudinal design using interviews to assess processes and outcomes at baseline (0 months), post-intervention (6 months) and post-follow-up (12 months).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Adults (18 years and older) living with HIV who consider themselves medically stable and safe to engage in exercise.
  • Access to technology (computer/tablet, Wi-Fi, web-cam).
  • Willing to take part in a 12 month study involving thrice weekly exercise.

排除标准

  • Not applicable.

结局指标

主要结局

Physical Activity

时间窗: Weekly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 12 months (48 weeks).

Change in trend (slope) in self-reported physical activity during the intervention phase (6 months) and the follow-up phase (6 months) as measured by i) whether they achieved the weekly recommended Canadian Physical Activity Guidelines, and ii) the number of days in the past week engaged in ≥30 min of moderate to vigorous physical activity (single item physical activity questionnaire).

次要结局

  • Health(Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.)
  • Disability(Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.)
  • Engagement in Care(Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.)
  • Mental Health(Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.)

研究者

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

Kelly O'Brien

Associate Professor

University of Toronto

研究点 (2)

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