Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons With Stroke
NCT ID: NCT06655402
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2025-03-25
2029-03-31
Brief Summary
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Detailed Description
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The specific aims are to determine the effects of CARE-CITE on stroke survivors' upper extremity functional capacity (Aim 1), upper extremity daily activity performance (accelerometry and patient-reported measures), and social participation (Aim 2). Additionally, the investigators will evaluate the effects on care partner strain, conflict around stroke recovery, and quality of life (Aim 3).
Study participants will be identified and recruited within the Emory Healthcare system and regional Atlanta hospitals, partnering with clinical staff for referrals and meeting with local stroke support groups. All Emory Rehabilitation Hospital stroke admissions will be screened based on study inclusion/exclusion criteria and contacted by the research coordinator, if eligible. The project coordinator will make a virtual screening appointment for interested participants. If screening criteria are met, the informed consent will be reviewed and obtained virtually to enroll the dyad.
Individual participant's enrollment in the study will last 29 weeks. All study visits will be virtual. Over 4 study evaluation sessions (\~2hrs/dyad), the research team will collect stroke survivor (SS) and care partner (CP) data at baseline and after the intervention using questionnaires and objective measures of upper extremity recovery. Upper extremity recovery will be evaluated by direct observation during the virtual assessments and through wearable sensors (worn on the stroke survivor's wrists for 3-7 days during the assessment periods).
The intervention will last 4 weeks. During the intervention period, dyads in both the intervention and attention control groups will receive two virtual home visits and two phone check-in visits. A research therapist will guide the SS and CP in the development of goals and a home exercise program to improve the upper extremity function of the SS. During the follow-up period, dyads will receive one 30-minute check-in booster call and a 2-hour booster virtual home visit. Care Partners in the intervention group will review CARE-CITE during the 4-week intervention period. CARE-CITE is a user-friendly, web-based program that features exemplary and interactive videos of family scenarios surrounding upper extremity rehabilitation at home. CP in the Attention Control group will receive traditional written family educational materials to review during the 4-week intervention period.
Aligned with the NIH Research Plan on Rehabilitation, this work will impact the development of innovative family-level interventions to improve SS and CP outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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CARE-CITE- CarePartners (Intervention Group)
The CP will receive virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program.
CARE-CITE
CARE-CITE is a post-stroke family education program, to support care partners (CPs) in aiding stroke survivors (SS) during rehabilitation. Utilizing autonomy-supportive strategies, CARE-CITE emphasizes empathy, choice, and problem-solving while minimizing controlling language.
The program features a user-friendly web-based platform with interactive videos that guide CPs in providing support for SS. Over four weeks, CPs engage in two virtual home visits and two phone check-ins. During the initial visit, CPs review online modules, set collaborative goals, and co-create a home exercise plan targeting upper extremity (UE) activities. The second and third weeks involve structured phone calls to discuss autonomy-supportive strategies and address challenges.
The final visit reinforces strategies, assesses SS progress, and adjusts rehabilitation goals. Each module is designed to foster motivation and effective practice in daily activities.
CARE-CITE- Stroke Survivors (Intervention Group)
This study arm consists of stroke survivors (SS) of carepartners receiving the virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program.
CARE-CITE
CARE-CITE is a post-stroke family education program, to support care partners (CPs) in aiding stroke survivors (SS) during rehabilitation. Utilizing autonomy-supportive strategies, CARE-CITE emphasizes empathy, choice, and problem-solving while minimizing controlling language.
The program features a user-friendly web-based platform with interactive videos that guide CPs in providing support for SS. Over four weeks, CPs engage in two virtual home visits and two phone check-ins. During the initial visit, CPs review online modules, set collaborative goals, and co-create a home exercise plan targeting upper extremity (UE) activities. The second and third weeks involve structured phone calls to discuss autonomy-supportive strategies and address challenges.
The final visit reinforces strategies, assesses SS progress, and adjusts rehabilitation goals. Each module is designed to foster motivation and effective practice in daily activities.
Actigraph GT3X+
Accelerometry data will be collected using Actigraph GT3X+ wearable sensors, approved by the FDA. The device does not collect or store individually identifiable health information (IIHI), private health information (PHI), or sensitive data. It is not intended for diagnosing, treating, or preventing diseases. These small, wrist-worn monitors document physical movement for physiological monitoring, including tracking movement during sleep. They can analyze circadian rhythms and assess activity in situations where quantifiable analysis of physical motion is needed.
Attention Control Group-CarePartners
CP in this group will receive traditional written family educational materials to review during the 4-week intervention period.
Attention Control Group
Over a similar 4-week period, the SS and CP will receive the same number of structured virtual weekly visits as the CARE-CITE group without the review of CARE-CITE modules.
The CP will receive a brochure with general caregiving information and website resources. At week 1, a separate control group intervention therapist will deliver a 2-hour virtual home visit to evaluate SS UE function and assess safety concerns. Based on SS impairments, a home exercise program will be prescribed for flexibility, strength, and coordination (6-8 exercises, 2 sets of 10 reps). SS will be encouraged to practice daily (targeting 30 min/day). Weeks 2 and 3: CP Phone check-ins \[15-minute\]. The intervention therapist will review safety, assess adverse events, and CP's use of web resources. Week 4 Virtual Home visit (2 hours). Review SS's progress with the UE activity home exercise program, discuss safety concerns, and progress UE exercises as appropriate.
Attention Control Group-Stroke Survivors
This study arm consists of stroke survivors (SS) of carepartners receiving the traditional written family educational materials to review during the 4-week intervention period.
Attention Control Group
Over a similar 4-week period, the SS and CP will receive the same number of structured virtual weekly visits as the CARE-CITE group without the review of CARE-CITE modules.
The CP will receive a brochure with general caregiving information and website resources. At week 1, a separate control group intervention therapist will deliver a 2-hour virtual home visit to evaluate SS UE function and assess safety concerns. Based on SS impairments, a home exercise program will be prescribed for flexibility, strength, and coordination (6-8 exercises, 2 sets of 10 reps). SS will be encouraged to practice daily (targeting 30 min/day). Weeks 2 and 3: CP Phone check-ins \[15-minute\]. The intervention therapist will review safety, assess adverse events, and CP's use of web resources. Week 4 Virtual Home visit (2 hours). Review SS's progress with the UE activity home exercise program, discuss safety concerns, and progress UE exercises as appropriate.
Actigraph GT3X+
Accelerometry data will be collected using Actigraph GT3X+ wearable sensors, approved by the FDA. The device does not collect or store individually identifiable health information (IIHI), private health information (PHI), or sensitive data. It is not intended for diagnosing, treating, or preventing diseases. These small, wrist-worn monitors document physical movement for physiological monitoring, including tracking movement during sleep. They can analyze circadian rhythms and assess activity in situations where quantifiable analysis of physical motion is needed.
Interventions
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CARE-CITE
CARE-CITE is a post-stroke family education program, to support care partners (CPs) in aiding stroke survivors (SS) during rehabilitation. Utilizing autonomy-supportive strategies, CARE-CITE emphasizes empathy, choice, and problem-solving while minimizing controlling language.
The program features a user-friendly web-based platform with interactive videos that guide CPs in providing support for SS. Over four weeks, CPs engage in two virtual home visits and two phone check-ins. During the initial visit, CPs review online modules, set collaborative goals, and co-create a home exercise plan targeting upper extremity (UE) activities. The second and third weeks involve structured phone calls to discuss autonomy-supportive strategies and address challenges.
The final visit reinforces strategies, assesses SS progress, and adjusts rehabilitation goals. Each module is designed to foster motivation and effective practice in daily activities.
Attention Control Group
Over a similar 4-week period, the SS and CP will receive the same number of structured virtual weekly visits as the CARE-CITE group without the review of CARE-CITE modules.
The CP will receive a brochure with general caregiving information and website resources. At week 1, a separate control group intervention therapist will deliver a 2-hour virtual home visit to evaluate SS UE function and assess safety concerns. Based on SS impairments, a home exercise program will be prescribed for flexibility, strength, and coordination (6-8 exercises, 2 sets of 10 reps). SS will be encouraged to practice daily (targeting 30 min/day). Weeks 2 and 3: CP Phone check-ins \[15-minute\]. The intervention therapist will review safety, assess adverse events, and CP's use of web resources. Week 4 Virtual Home visit (2 hours). Review SS's progress with the UE activity home exercise program, discuss safety concerns, and progress UE exercises as appropriate.
Actigraph GT3X+
Accelerometry data will be collected using Actigraph GT3X+ wearable sensors, approved by the FDA. The device does not collect or store individually identifiable health information (IIHI), private health information (PHI), or sensitive data. It is not intended for diagnosing, treating, or preventing diseases. These small, wrist-worn monitors document physical movement for physiological monitoring, including tracking movement during sleep. They can analyze circadian rhythms and assess activity in situations where quantifiable analysis of physical motion is needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to read and write English,
* Mini-mental test score greater than 24
* Individuals who are a spouse/partner or family member dwelling in the same household and self-identify as the primary caregiver of the SS.
Stroke Survivors (SS):
* Must be at least18 years old
* More than 3 months and less than 2yrs post-ischemic or hemorrhagic event
* Discharged home from the hospital with minimal to moderate UE deficits (can actively initiate 20 degrees of wrist and 10 degrees of finger extension)
* Mini-mental test greater than 24
* No physician determined medical problems that would limit participation,
* Must have CP living in the home
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Emory University
OTHER
Responsible Party
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Sarah Blanton
Professor
Principal Investigators
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Sarah Blanton, PT, DPT
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory Rehabilitation Hospital
Atlanta, Georgia, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY00007645
Identifier Type: -
Identifier Source: org_study_id
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