Clinical trial NCT06207084: The Fit with Us Study
Official title: Precision-based Teleexercise Trial to Increase Adherence in People with Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mobility Limitations
Disability Physical
Telehealth
Health Coaching
Physical Activity
Behavior, Health
EHealth
Health Literacy
Self Efficacy
Fatigue
Usability
Predictive Model
Keywords: telehealth
health coaching
disability
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Sequential Multiple Assignment Randomization Model
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this 32 week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions.

All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one on one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre recorded exercise content and articles for another 8 weeks. After final surveys, participants will have open access to the website for another 16 weeks where we will passively observe their fitbit and website data.

The study outcomes are:

The effectiveness of the adaptive interventions Exploring mediating and moderating variables Sensitivity analysis of the predictive analytics

Detailed description: The proposed Sequential Multiple Assignment Randomized Trial (SMART) study seeks to develop an effective 32-week, resource sensitive strategy to improve physical activity levels in people with mobility impairments.

During the run-In period before the start of the intervention, interested individuals will consent to be part of the study. Once providing consent, Participants will respond to a baseline survey packet through REDCap. Additionally, during the run-in period, the research team will ship an exercise tracker device, and a set of wrist weights for the participant to wear during the intervention. The participant will receive an orientation call to assist them with using the website, setting up their exercise tracking device, and linking the device to the website. (see attached call outline)

After the run-in period, participants will be randomized into 1 of 2 groups: Asynchronous Exercise Program (AEP) and AEP + Smart Health Coaching (SHC). Finally, participants will be given access to the FitWithUs online platform, hosted on UAB servers, to access all the exercise content (exercise videos and articles).

The Adoption Phase will be split into two 4-week phases: early adoption (weeks 1 to 4) and late adoption (weeks 5 to 8). Participants in both groups will engage in pre-recorded exercise content. The AEP + SHC group may receive up to 8 health coaching calls.

At the end of the early adoption phase, the participant will complete a short set of questions (See week 4 questionnaire) the research team will classify participants in both groups into either a responder or a non-responder. If a participant is a responder, they will continue with their group assignment through the late adoption phase (AEP only or AEP + SHC). If the participant is a non-responder, they will be randomized a second time into 1 of 2 sub-groups: Live 1-on-1 training or Live group training for the late adoption phase. All live training will occur remotely through ZOOM. Participants in non-responder sub-groups will be asked to participate in their respective live training up to 3 times per week for weeks 5 to 8.

Upon finishing the late adoption phase, all participants will complete another survey packet and a semi-structured interview (see interview guide), and receive AEP only for an 8-week Maintenance phase (weeks 9 to 16). Upon completion of week 16, the participant will complete a final survey packet. Participants will receive access to the website and content for another 16 weeks and complete a final survey packet. Throughout the study, we will be collecting data from the participant's exercise tracker. These data include steps and minutes of activity/inactivity. During weeks 16 to 32, Participants will have open access to the website and i's library of exercise content. The research team will continue to collect activity data and website analytics (for example video watch minutes). Participants may receive a reminder call to complete 4th week or 8 week surveys. (see attached call outline)

This intervention will be administered in waves of about 33 to 34 participants. The first wave will be a pilot wave. The data generated from this pilot wave will not be included in the final analyses, but serve as a test for the intervention. Additionally, pilot wave participants will be asked to complete semi-strucutred interview at the end of both week 8 and week 16.

After completion of the pilot wave, the research team may modify or refine the intervention and submit an amendment to the IRB. After approval is obtained, the remaining intervention waves will proceed. (See attached Pilot Wave Consent)

We will use the following validated measures:

Surveys (see attached)

Demographic and Health History Questionnaire (baseline)

Godin Leisure Time Exercise Questionnaire (GLTEQ)

Patient Reported Outcomes Measurement Information System Short-Form Fatigue (PROMIS SF-F))

Social Cognitive Theory Social Provisions Scale (SPS)

Barriers to Self-Efficacy Scale for Physical Activity (BARSE-PA)

eHealth Literacy Scale (eHEALS)

36-Item Short Form Survey: physical functioning (SF36 PF)

mHealth Application Usability Questionnaire (MAUQ)

Acceptability of Intervention Appropriateness Measure, Intervention Appropriateness Measure, \&amp; Feasibility of Intervention Measure.

Eligibility criteria: Inclusion Criteria:

* age 18 to 64 years have a permanent mobility impairment has internet access can converse in English

Exclusion Criteria:

Significant visual acuity that prevents seeing a computer screen to follow a home exercise program has been exercising for the past 6 months or longer.

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Primary outcomes:
measure: Adherence
timeFrame: 8 weeks
Secondary outcomes:
measure: effectiveness
timeFrame: 8 weeks
measure: physical activity and fatigue
timeFrame: 16
measure: cost effectiveness
timeFrame: 32
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Wellness, Health and Research Facility
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Mohanraj Thirumalai, PhD
role: PRINCIPAL_INVESTIGATOR
References: