Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons With Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Emory University
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- SS's Upper Extremity Functional Capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
Arms & Interventions
CARE-CITE- CarePartners (Intervention Group)
The CP will receive virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program.
Intervention: CARE-CITE (Behavioral)
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.
Intervention: CARE-CITE (Behavioral)
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.
Intervention: Actigraph GT3X+ (Other)
Attention Control Group-CarePartners
CP in this group will receive traditional written family educational materials to review during the 4-week intervention period.
Intervention: Attention Control Group (Behavioral)
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.
Intervention: Attention Control Group (Behavioral)
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.
Intervention: Actigraph GT3X+ (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- SS UE self-efficacy using the Confidence in Hand and Movement Scale (CAHM) score(Baseline, 2 months and 6 months post-intervention)
Investigators
Sarah Blanton
Professor
Emory University