Clinical trial NCT06655402: Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons With Stroke
Official title: Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Caregiver Burden
Keywords: Stroke Survivors
Carepartners
Caregivers
Post-Stroke Recovery
Telehealth
Rehabilitation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-10-23
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The goals of this study are to use a fully virtual, two-group randomized clinical trial to assess the efficacy of CARE-CITE and the sustainability of improvements compared to an attention control group.

The specific aims are to determine the effects of CARE-CITE on stroke survivors' upper extremity functional capacity (Aim 1), upper extremity daily activity performance (accelerometry and patient-reported measures), and social participation (Aim 2). Additionally, the investigators will evaluate the effects on care partner strain, conflict around stroke recovery, and quality of life (Aim 3).

Study participants will be identified and recruited within the Emory Healthcare system and regional Atlanta hospitals, partnering with clinical staff for referrals and meeting with local stroke support groups. All Emory Rehabilitation Hospital stroke admissions will be screened based on study inclusion/exclusion criteria and contacted by the research coordinator, if eligible. The project coordinator will make a virtual screening appointment for interested participants. If screening criteria are met, the informed consent will be reviewed and obtained virtually to enroll the dyad.

Individual participant's enrollment in the study will last 29 weeks. All study visits will be virtual. Over 4 study evaluation sessions (\~2hrs/dyad), the research team will collect stroke survivor (SS) and care partner (CP) data at baseline and after the intervention using questionnaires and objective measures of upper extremity recovery. Upper extremity recovery will be evaluated by direct observation during the virtual assessments and through wearable sensors (worn on the stroke survivor's wrists for 3-7 days during the assessment periods).

The intervention will last 4 weeks. During the intervention period, dyads in both the intervention and attention control groups will receive two virtual home visits and two phone check-in visits. A research therapist will guide the SS and CP in the development of goals and a home exercise program to improve the upper extremity function of the SS. During the follow-up period, dyads will receive one 30-minute check-in booster call and a 2-hour booster virtual home visit. Care Partners in the intervention group will review CARE-CITE during the 4-week intervention period. CARE-CITE is a user-friendly, web-based program that features exemplary and interactive videos of family scenarios surrounding upper extremity rehabilitation at home. CP in the Attention Control group will receive traditional written family educational materials to review during the 4-week intervention period.

Aligned with the NIH Research Plan on Rehabilitation, this work will impact the development of innovative family-level interventions to improve SS and CP outcomes.

Eligibility criteria: 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

Primary outcomes:
measure: SS's Upper Extremity Functional Capacity
timeFrame: Baseline, 2 months and 6 months post-intervention
measure: SS's UE activity performance using the Motor Activity Log (MAL)
timeFrame: Baseline, 2 months and 6 months post-intervention
measure: SS's Social Participation Score using the Stroke Impact Scale (SIS) score
timeFrame: Baseline, 2 months and 6 months post-intervention
measure: CP Quality of Life
timeFrame: Baseline, 2 months and 6 months post-intervention
measure: CP Strain using the Caregiver Strain Index(CSI)
timeFrame: Baseline, 2 months and 6 months post-intervention
Secondary outcomes:
measure: SS Upper Extremity Functional capacity (ArmCAM)
timeFrame: Baseline, 2 months and 6 months post-intervention
measure: SS's Upper Extremity activity performance (accelerometry)
timeFrame: Baseline, 2 months and 6 months post-intervention
measure: Family Conflict using the Family Caregiver Conflict Scale (FCCS) score
timeFrame: Baseline, 2 months and 6 months post-intervention
measure: Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score
timeFrame: Baseline, 2 months and 6 months post-intervention
measure: Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score
timeFrame: Baseline, 2 months and 6 months post-intervention
measure: SS UE self-efficacy using the Confidence in Hand and Movement Scale (CAHM) score
timeFrame: Baseline, 2 months and 6 months post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Rehabilitation Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Sarah Blanton, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: