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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Significant cognitive deficits

Trial design

Design model

Parallel

Treatments tested in this trial

  • CARE-CITE

    Behavioral

    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

    Behavioral

    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+

    Other intervention

    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.

Treatment groups

220 Participants
are divided into 4 treatment groups
Group A: CARE-CITE- CarePartners (Intervention Group)Experimental treatment 1 intervention
Group B: CARE-CITE- Stroke Survivors (Intervention Group)Experimental treatment 2 interventions
Group C: Attention Control Group-CarePartnersActive comparator 1 intervention
Group D: Attention Control Group-Stroke SurvivorsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 2 months and 6 months post-intervention
2

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.

Time frame
Baseline, 2 months and 6 months post-intervention
3

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.

Time frame
Baseline, 2 months and 6 months post-intervention
4

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.

Time frame
Baseline, 2 months and 6 months post-intervention

Secondary outcomes

1

SS Upper Extremity Functional capacity (ArmCAM)

Arm Capacity and Movement Test (ArmCAM). A therapist standardized assessment. A 10-item scale (range = 0-30); designed specifically to evaluate UE motor function virtually by videoconferencing.

Time frame
Baseline, 2 months and 6 months post-intervention
2

SS's Upper Extremity activity performance (accelerometry)

Accelerometers will be worn for all activities over 3-7 days except for water-based activities. These activities include activities of daily living. Accelerometry data will be gathered via Actigraph GT3X+ wearable sensors per FDA definition and approval of device use. After the virtual baseline (T0) data collection visit, the blinded data collector (licensed physical or occupational therapist) will review the accelerometer procedures with the dyad, confirm proper donning and UE wrist placement of the devices, and wear-time of 3-7 days.

Time frame
Baseline, 2 months and 6 months post-intervention
3

Family Conflict using the Family Caregiver Conflict Scale (FCCS) score

The FCCS is a unidimensional, Likert-type scale composed of 15 items. Each item response is in a Likert-type format with participants indicating their agreement with the item with 1 "not true at all" to 7 "very true." Item scores are summed and higher scores represent higher levels of conflict within a family. Total scores Range 15-105.

Time frame
Baseline, 2 months and 6 months post-intervention
4

Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score

Autonomy support for carepartners will be assessed by the Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale. An autonomy-supportive environment is characterized by empathy, communicating choices (avoiding controlling language), providing rationales and problem-solving. Questions are asked about the carepartner's perspective on how much they provide an autonomy supportive environment for the stroke survivor. The FCCQ-CP includes 14 items scored from 1 to 7 where 1 = not true at all and 7 = very true. Item scores are averaged to provide an overall score between 1 and 7 where higher scores indicate the carepartner thinks they are providing high autonomy support to the stroke survivor.

Time frame
Baseline, 2 months and 6 months post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator