Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons With Stroke
CARE-CITE
3 other identifiers
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Mar 2025
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2024
CompletedFirst Posted
Study publicly available on registry
October 23, 2024
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
April 29, 2026
April 1, 2026
3.9 years
October 22, 2024
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
SS's Upper Extremity Functional Capacity
Upper Extremity Fugl Meyer (FM) therapist standardized assessment. Total score=sum of 33 items; range 0-66 higher score, less UE impairment.
Baseline, 2 months and 6 months post-intervention
SS's UE activity performance using the Motor Activity Log (MAL)
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.
Baseline, 2 months and 6 months post-intervention
SS's Social Participation Score using the Stroke Impact Scale (SIS) score
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.
Baseline, 2 months and 6 months post-intervention
CP Quality of Life
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.
Baseline, 2 months and 6 months post-intervention
CP Strain using the Caregiver Strain Index(CSI)
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.
Baseline, 2 months and 6 months post-intervention
Secondary Outcomes (6)
SS Upper Extremity Functional capacity (ArmCAM)
Baseline, 2 months and 6 months post-intervention
SS's Upper Extremity activity performance (accelerometry)
Baseline, 2 months and 6 months post-intervention
Family Conflict using the Family Caregiver Conflict Scale (FCCS) score
Baseline, 2 months and 6 months post-intervention
Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score
Baseline, 2 months and 6 months post-intervention
Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score
Baseline, 2 months and 6 months post-intervention
- +1 more secondary outcomes
Study Arms (4)
CARE-CITE- CarePartners (Intervention Group)
EXPERIMENTALThe CP will receive virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program.
CARE-CITE- Stroke Survivors (Intervention Group)
EXPERIMENTALThis study arm consists of stroke survivors (SS) of carepartners receiving the virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program.
Attention Control Group-CarePartners
ACTIVE COMPARATORCP in this group will receive traditional written family educational materials to review during the 4-week intervention period.
Attention Control Group-Stroke Survivors
ACTIVE COMPARATORThis 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 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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Significant cognitive deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emory Rehabilitation Hospital
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Blanton, PT, DPT
Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 22, 2024
First Posted
October 23, 2024
Study Start
March 25, 2025
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Investigators will share data associated with a publication through DASH no later than the first date of the electronic publication and will share all study data by the end of the award performance period.
- Access Criteria
- The research community will have access to the data when the award ends. The data will be preserved indefinitely and is subject to decisions by NICHD DASH.
The investigator will share de-identified participant-level data in both raw and pre-processed forms on NICHD DASH to facilitate replication and validation of findings associated with each aim.