NCT06655402 · Emory University
Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons With Stroke
(CARE-CITE)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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.
OTHER
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 measures
SS's Upper Extremity Functional Capacity
Time frame: Baseline, 2 months and 6 months post-intervention
Upper Extremity Fugl Meyer (FM) therapist standardized assessment. Total score=sum of 33 items; range 0-66 higher score, less UE impairment.
SS's UE activity performance using the Motor Activity Log (MAL)
Time frame: Baseline, 2 months and 6 months post-intervention
MAL, a 30-item questionnaire, Likert-type scale, assessing the use of the affected arm during normal daily activities. Responses are given on a Likert-type scale where 0= the weaker arm was not used at all for that activity (never) to 5=the ability to use the weaker arm for that activity was as good as before the stroke (normal). The total scores are the average of all items and range from 0 to 5, where higher values indicate the greater function of the arm impacted by the stroke. A high score/high-quality UE use.
SS's Social Participation Score using the Stroke Impact Scale (SIS) score
Time frame: Baseline, 2 months and 6 months post-intervention
Stroke Impact Scale (SIS), is a stroke-specific self-report questionnaire (59 items across 8 domains) that measures how a stroke has impacted a participant's health. The Social Participation Domain: rated in a 5-point Likert scale regarding the difficulty the participant has experienced completing each item (range 0-100). Higher scores, higher social participation.
CP Quality of Life
Time frame: Baseline, 2 months and 6 months post-intervention
CP will complete the Bakas Caregiving Outcomes Scale (BCOS). BCOS is a unidimensional scale based on 15 items and addresses changes in caregiving social functioning, subjective well-being, and physical health. Participants respond to statements on a 7-point Likert scale (-3 =changed for the worst, +3 = changed for the best, with 0 meaning did not change). The -3 to +3 ratings are recoded to 1-7 so positive numbers used for analysis. Total BCOS score ranges from 15-105. A Cut-off score \>60 = positive life changes. Higher scores, better caregiving outcomes.
CP Strain using the Caregiver Strain Index(CSI)
Time frame: Baseline, 2 months and 6 months post-intervention
Caregiver Strain Index (CSI), self-reported. A 13-question tool that measures strain related to care provision with binary yes/no answers. There is at least one item for each major domain: Employment, Financial, Physical, Social, and Time. Scoring ranges from 0 to 13, with scores of 7 or more indicating a greater level of stress. Higher scores, more strain.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations