RecruitingNot ApplicableNCT06655402

Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons With Stroke

Sponsor

Emory University

Enrollment

220 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke Caregiver Burden

Summary

Stroke is a leading cause of long-term disability. Research has placed little emphasis on integrating care partners (CP) (family members) into the rehabilitation process without increasing negative care partner outcomes. The research team has developed and implemented a novel, web-based care partner-focused intervention (CARE-CITE) designed to foster problem-solving and skill building while facilitating care partner engagement during stroke survivor (SS) upper extremity practice of daily activities in the home setting. By providing a family-focused approach to rehabilitation interventions, this project will help develop more effective treatments that improve CP and outcomes after stroke.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

CarePartners (CP):
Must be at least18 years old,
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 Criteria1

Significant cognitive deficits

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Interventions

BEHAVIORALCARE-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.

BEHAVIORALAttention 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.

OTHERActigraph 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.