Tele-Coaching Community-Based Exercise (CBE) Study

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05006391
• Other study ID #: REB Protocol #40410
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: May 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Not applicable.

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• Tele-Coaching (Online) Community-Based Exercise
PHASE 1-Intervention Phase (6 months): Participants will engage in an individual tailored home-based exercise program involving aerobic, resistance, balance and flexibility training ~60min, 3 times per week for 24 weeks. Intervention will include: Component 1) biweekly 60 min personal online coaching with a certified trainer from the YMCA (13 sessions) who will monitor and progress exercise intensity; Component 2) weekly online group-based exercise classes ~60 min each led by a trainer at YMCA; Component 3) monthly online evidence-based self-management education sessions focused on topics related to self-management and health, and physical activity living with HIV; and Component 4) a wireless physical activity monitor (WPAM) to self-monitor steps, distance, calories burned, and active minutes. PHASE 2: Post-Intervention (6 months): Participants will be encouraged to continue with unsupervised home / outdoor-based exercise 3 times per week and to continue using their WPAM throughout.

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Ontario HIV Treatment Network, YMCA

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Extrinsic Contextual Factor - HIV Stigma	Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the Short Form HIV Stigma Scale.	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
Other	Intrinsic Contextual Factor - Mastery	Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the Pearlin Mastery Scale.	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
Primary	Physical Activity	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).	Weekly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 12 months (48 weeks).
Secondary	Disability	Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the Short Form HIV Disability Questionnaire (SF-HDQ).	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
Secondary	Health	Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the EQ-5D-5L.	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
Secondary	Mental Health	Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the Patient Health Questionnaire (PHQ-8).	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
Secondary	Engagement in Care	Change in trend (slope) in disability as during the intervention phase (6 months) and the follow-up phase (6 months) as measured by the HIV Index of Engagement questionnaire.	Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.