United4Stroke (U4S) - El Paso Network: Community Health Program With Group-Based Education
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Daily Step Count
Study Overview
Brief Summary
What is United4Stroke (U4S)? United4Stroke is a research program at the University of Texas at El Paso (UTEP) that aims to help stroke survivors become more active and reduce sedentary time through education, movement, and personalized coaching.
Where Does It Happen?
All sessions take place at:
UTEP's Rehabilitation Sciences Complex located at 3333 North Mesa Street, El Paso, TX 79902
What is Involved?
The program includes 12 total visits over several months:
- 8 group sessions (held every two weeks)
- 4 individual evaluation visits (before, during, and after the program)
Who Can Participate?
- Individuals 18 years of age or older who have had a stroke at least 6 months prior to joining the study.
- Family caregivers may also join
What Happens During the Visits?
First Visit:
- Learn about the study and give consent
- Answer questions about memory, movement, general health, and daily activity
- Do walking and mobility tests
- Get fitted with a small movement sensor (ActivPAL) and a Fitbit
Group Sessions (Visits 2-8):
- Topics: physical activity, sitting less, balance and falls, and activities of daily living
- Led by UTEP physical therapy faculty
- Includes group discussions and hands-on activities
- Some participants will also get one-on-one coaching to help with physical activity engagement, daily step count, and reducing sedentary behavior.
Follow-Up Visits (Visits 9 and 11):
- Repeat earlier tests to check progress
- Share feedback about the program
Final Visit (Visit 10):
- Celebrate progress!
- Social gathering, certificates, and a presentation of results
Goal:
To support stroke survivors in becoming more active and living healthier, more independent lives-step by step.
Detailed Description
Specific Aims:
Aim 1: To evaluate the adherence rate, attendance, and satisfaction associated with a community health program that combines group-based education with individual coaching sessions for stroke survivors and their caregivers.
Hypothesis 1.1: A community health program incorporating group-based education and individual coaching sessions for stroke survivors will demonstrate acceptable rates of adherence and attendance.
Hypothesis 1.2: Stroke survivors and their caregivers will report satisfaction with a group-based education community health program.
Aim 2: To examine the effects of a community health program that combines group-based education with individual coaching sessions for stroke survivors and their caregivers on physical activity (PA), sedentary behavior (SB), and quality of life (QoL).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals will be included if they are ≥ 18-years old, have had a stroke at least 6 months prior to baseline assessment, have a means of transportation to the UTEP physical therapy building to attend the program/visits, and are clinically stable (the participant's health is not rapidly worsening and there may be a level of stability in their overall health status).
Exclusion Criteria
- •Individuals will be excluded if they are unable to consent, if they do not have a means of transportation to attend the program/study visits, if they require a caregiver and the caregiver is unable to attend, if they walk greater than an average of 7,000 steps a day, if they walk at a speed less than or equal to 0.3 m/s, or if the participant attends less than 60% of the group-based educational sessions.
Arms & Interventions
Group-Based Education Only
Participants assigned to the group-based education arm will attend the U4S program which will consist of group-based educational sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. This group will not receive individualized coaching aimed at increasing daily step count, but will receive a Fitbit to be worn during the program.
Intervention: Group-Based Education (Behavioral)
Group-Based Education plus Individualized Coaching
Participants assigned to the group-based education arm will attend the U4S program which will consist of group-based educational sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. This group will receive individualized coaching aimed at increasing daily step count, reducing sedentary behavior, and engaging in physical activities. They will also receive a Fitbit to be worn during the program.
Intervention: Group-Based Education (Behavioral)
Group-Based Education plus Individualized Coaching
Participants assigned to the group-based education arm will attend the U4S program which will consist of group-based educational sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. This group will receive individualized coaching aimed at increasing daily step count, reducing sedentary behavior, and engaging in physical activities. They will also receive a Fitbit to be worn during the program.
Intervention: Individualized Coaching (Behavioral)
Outcomes
Primary Outcomes
Daily Step Count
Time Frame: Baseline, week 6 (during intervention), week 13 (post-intervention), and week 19 (follow-up).
Daily step count data will be collected.
Secondary Outcomes
- Quality of Life (QoL)(Baseline, week 13 (post-intervention), and week 19 (follow-up).)
- Mobility Performance(Baseline, week 13 (post-intervention), and week 19 (follow-up).)
- Sedentary Behavior (Objective)(Baseline, week 6 (during intervention), week 13 (post-intervention), and week 19 (follow-up).)
- Sedentary Behavior (Subjective)(Baseline, week 13 (post-intervention), and week 19 (follow-up).)
Investigators
Camila Torriani Pasin
Associate Professor
University of Texas, El Paso