Clinical trial NCT06970210: United4Stroke (U4S) - El Paso Network Stroke Community Program
Official title: United4Stroke (U4S) - El Paso Network: Community Health Program With Group-Based Education
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Keywords: Stroke
Quality of Life
Sedentary Behaviors
Sedentary Lifestyle
Physical Inactivity
Community Health Education
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Hypothesis 2.1: The community health program, integrating group-based education with individual coaching sessions, will increase daily step count among stroke survivors more effectively than group-based education alone.

Hypothesis 2.2: The community health program, which combines group-based education with individual coaching sessions, will decrease SB among stroke survivors more effectively than group-based education alone.

Hypothesis 2.3: The community health program, which combines group-based education with individual coaching sessions, will improve the QoL of stroke survivors and their caregivers more effectively than group-based education alone.

Hypothesis 2.4: The one-month follow-up will show higher retention rates for the group intervention. Specifically, the community health program that combines group-based education with individual coaching will result in a greater rate of maintenance of daily step count, lower time spent in SB, and greater self-reported QoL one month after the program concludes when compared to group-based education alone.

Study Design and Methods:

The U4S project will employ a randomized controlled trial (RCT), following the Consolidated Standards of Reporting Trials (CONSORT) design. Participants will be recruited from community health centers and rehabilitation facilities throughout the Paso Del Norte region, supported by local healthcare providers and community organizations. A community engagement strategy will rely on ambassadors utilizing the partner mobile IT platform (High Enroll/ Patient Enroll) to promote the study through tailored marketing campaigns. Inclusion criteria are designed to ensure a focus on chronic stroke survivors: individuals aged 18 or older who are at least six months post-stroke, with the ability to participate in group sessions and provide informed consent. Recruitment will be facilitated through outreach to stroke support groups, healthcare providers, and community organizations within the region.

Recruitment and Participants:

Power calculations suggest that the RCT with a 5% significance level and moderate effect size (Cohen's f=0.5) will maintain 80% power with n=17 observations per group and 90% power with n=23 per group. This implies that with at least 46 total participants, we can maintain a well-powered experiment (90%), and with only 34 total subjects, we will have a moderately powered experiment (80%). All power calculations were performed in R 17 using the pwr package18. Over the course of 3 years, we aim to recruit 46 participants, averaging 23 participants per group (control and experimental). Each semester (3 semesters in total) will consist of two cohorts of 4 participants for each group, all of whom will be randomly assigned to either the control or intervention group. Participants in the control group will attend group-based education sessions covering essential stroke recovery topics, including awareness of PA engagement, reduction of SB, performance of activities of daily living (ADLs), and balance and fall risk. Group discussions will encourage social engagement, aiming to foster a sense of community and support among participants. In addition to the group education sessions, participants in the intervention group will receive one-on-one coaching from trained health professionals to set personalized health goals, with a primary focus on increasing daily step count. Coaching sessions will use motivational interviewing techniques to address ambivalence and enhance readiness for behavior change. Individualized action plans will be developed, focusing on the creation of SMART goals to incrementally increase daily steps. Based on baseline data or data collected at each visit, participants will be encouraged to achieve step count increases of 2%, 5%, or 10% per week or visit, depending on their readiness and willingness to progress. The intervention will span 12 weeks, with each group attending twelve visits at two-week intervals. Each session will last approximately one hour and a half, combining interactive education, group discussions, and individualized goal setting. The intervention integrates physical and psychosocial barriers and facilitators with SDH-focused strategies that address barriers commonly faced by Hispanic/Latino stroke survivors.

Description of Work:

This research project will encompass twelve visits to UTEP's Physical Therapy and Movement Sciences Department, where our laboratory is located. The first visit to the clinic will include the collection of demographics, sample characterization using scores from the Montreal Cognitive Assessment (MoCa), the Charlson Comorbidity Index (CCI), and the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA). We will also administer questionnaires that assess physical activity using the Human Activity Profile (HAP), sedentary behavior using the Sedentary Behavior Questionnaire (SBQ), and quality of life using the Stroke Impact Scale (SIS 3.0). Then, we will conduct several functional assessments including the Timed-Up-and-Go (TUG) test, the Five Times Sit to Stand Test (FTSTS), and the Ten Meters Walk Test (10MWT) in a randomized order. At the end of the visit, we will place an ActivPAL sensor on the stroke survivor that will record their number of steps, number of sit to stand transitions, and sedentary behavior based on the amount of time spent in different postural positions (i.e., sitting, lying) for seven days as a baseline measurement prior to the program. Randomization will be performed using sealed, opaque envelopes and the participant will be allocated to the respective group. Then, the stroke survivor and their caregiver (if applicable) will attend a first session with group-based education and the experimental group will receive their first individualized coaching. Zoom calls for the individualized coaching will be scheduled as needed. The program will be composed of seven additional sessions with group-based education and the experimental group will receive personalized coaching regarding step count increase after each session. The group sessions will be led by the principal investigator, and other research personnel. During these sessions, social interactions amongst the stroke survivors and caregivers will be highly encouraged through group activities and conversations. Then, the experimental group of stroke survivors will receive personalized coaching from the research team. Through this individualized coaching, our aim is to support stroke survivors throughout the states of the Transtheoretical Model of Health Behavioral Change. To accomplish this, we will provide the stroke survivors with guided and tailored exercises, set SMART (specific, measurable, achievable, realistic, and timed) goals every two weeks, help the participants in forming long-lasting habits, identify barriers that may restrict the stroke survivors from participating in physical activity, and make proposals to reduce those barriers to implement a more active lifestyle. During the eighth visit, we will also place the ActivPAL sensors onto the participants which will monitor their sedentary behavior based on time spent in different postural positions (i.e., sitting, lying) for seven days. This will serve as a post-program measurement. Then, the stroke survivors and caregivers will be invited back to the lab individually (visit 9) where the stroke survivors will respond to questionnaires that assess physical activity (HAP), sedentary behavior (SBQ), and quality of life (SIS 3.0). Then, we will conduct several functional assessments including the TUG test, the FTSTS test, and the 10MWT that will be conducted in a randomized order. The TUG test will be conducted over three trials consisting of familiarization, self-selected speed, and fast speed. The 10MWT will be conducted over four randomized trials, consisting of two self-selected speed trials, and two fast speed trials. The FTSTS test will be conducted over three trials, in which the participant will be asked to complete each trial as fast as they can. The caregiver will be administered a questionnaire that assesses strain that they may or may not experience as a caregiver (MCSI). During this visit, both the stroke survivor and caregiver will be administered a survey to assess their satisfaction with the program. Then, participants will be invited for a closing event (10th visit) with additional social interactions, games, and distribution of certificates of completion. One month after the closing event, the participants and their caregivers (if applicable) will be invited back for a follow-up assessment comprised of two visits. The follow-up assessment will consist of identical questionnaires, functional assessments, and sensor placement as those described in previous individual visits.

Data Analysis:

Aim 1: The analysis of adherence rate, attendance frequency, and satisfaction will be accomplished by using descriptive statistics and data visuals, including a general reporting of the mean, minimum and maximum levels observed.

Aim 2: The program's effect on measures of QoL, SB, and PA levels will be analyzed by computing a paired t-test between pre- and post- scores that are generated from the questionnaires and assessments described above for control and intervention groups.

Expected Results:

In the short term, the U4S project is expected to yield measurable improvements in the adherence, attendance, and satisfaction rates of chronic stroke survivors and their caregivers participating in the community-based program. The combined group-based education and individual coaching intervention is anticipated to enhance physical activity, reduce sedentary behavior, and improve quality of life. Outreach efforts with a community engagement strategy will likely result in increased community-wide awareness and participation in the study, surpassing recruitment benchmarks from previous stroke studies. The strategic use of targeted marketing, mobile IT platforms, and Ambassadors will ensure effective engagement with underserved Hispanic/Latino populations in the Paso del Norte region. These short-term outcomes will provide actionable insights into the feasibility and immediate impact of the intervention and the effectiveness of the recruitment strategies. Over the long term, the U4S project is expected to establish a sustainable and scalable community-academic partnership model for addressing health disparities in the Paso del Norte region and beyond. The program's success will provide a foundation for advancing evidence-based, culturally tailored interventions to improve rehabilitation outcomes for chronic stroke survivors. The findings will contribute to the scientific understanding of community-engaged health programs and inform policies to reduce health disparities in underserved populations.

The data and insights generated from this project will provide the essential evidence to refine our research questions, methodologies, and hypotheses. The evidence from this project will validate our innovative intervention approach, confirming its feasibility and potential effectiveness in improving the quality of life, physical activity, and self-reported health outcomes for stroke survivors and their caregivers within the Hispanic/Latino community.

Eligibility criteria: 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.

Primary outcomes:
measure: Daily Step Count
timeFrame: Baseline, week 6 (during intervention), week 13 (post-intervention), and week 19 (follow-up).
Secondary outcomes:
measure: Sedentary Behavior (Objective)
timeFrame: Baseline, week 6 (during intervention), week 13 (post-intervention), and week 19 (follow-up).
measure: Sedentary Behavior (Subjective)
timeFrame: Baseline, week 13 (post-intervention), and week 19 (follow-up).
measure: Quality of Life (QoL)
timeFrame: Baseline, week 13 (post-intervention), and week 19 (follow-up).
measure: Quality of Life (QoL)
timeFrame: Baseline, week 13 (post-intervention), and week 19 (follow-up).
measure: Mobility Performance
timeFrame: Baseline, week 13 (post-intervention), and week 19 (follow-up).
measure: Mobility Performance
timeFrame: Baseline, week 13 (post-intervention), and week 19 (follow-up).
measure: Mobility Performance
timeFrame: Baseline, week 13 (post-intervention), and week 19 (follow-up).
Other outcomes:
measure: Feasibility (adherence)
timeFrame: Weeks 1-14 (intervention period)
measure: Feasibility (attendance frequency)
timeFrame: Weeks 1-14 (intervention period)
measure: Feasibility (satisfaction)
timeFrame: Week 13 (post-intervention)
Locations:
city: El Paso
country: United States
facility: The University of Texas at El Paso: Rehabilitation Sciences Complex
state: Texas
Study officials:
affiliation: The University of Texas at El Paso
name: Camila Torriani-Pasin, PhD, PT
role: PRINCIPAL_INVESTIGATOR
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