Recruiting

Telerehabilitation

Sponsor:

Emory University

Code:

NCT06655402

Conditions

Stroke

Caregiver Burden

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

CARE-CITE

Attention Control Group

Actigraph GT3X+

Study Details

Brief 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.

Conditions

Stroke

Caregiver Burden

Study ID

NCT06655402

Start date

Mar 25, 2025

Status verified date

Apr, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

CarePartners (CP):

Inclusion Criteria:

  • 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):

Inclusion Criteria:

  • 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 for CP and SS:

  • Significant cognitive deficits

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: CARE-CITE- CarePartners (Intervention Group)

The CP will receive virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program.

experimental: 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.

active comparator: Attention Control Group-CarePartners

CP in this group will receive traditional written family educational materials to review during the 4-week intervention period.

active comparator: 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.

Interventions

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.

Primary outcome measure

  • SS's Upper Extremity Functional Capacity [ Time Frame: Baseline, 2 months and 6 months post-intervention ]
  • SS's UE activity performance using the Motor Activity Log (MAL) [ Time Frame: Baseline, 2 months and 6 months post-intervention ]
  • SS's Social Participation Score using the Stroke Impact Scale (SIS) score [ Time Frame: Baseline, 2 months and 6 months post-intervention ]
  • CP Quality of Life [ Time Frame: Baseline, 2 months and 6 months post-intervention ]
  • CP Strain using the Caregiver Strain Index(CSI) [ Time Frame: Baseline, 2 months and 6 months post-intervention ]

Central Contacts and Locations

Central contacts

Sarah R Blanton, PT, DPT

(404) 712-2222sblanto@emory.edu

Locations

Emory Rehabilitation Hospital

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Emory University

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Stroke Survivors
  • Carepartners
  • Caregivers
  • Post-Stroke Recovery
  • Telehealth
  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-04-29.