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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 initia
• Поведенческое 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 flexibili
• Другое 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

Первичные конечные точки

• SS's Upper Extremity Functional Capacity [Срок оценки: Baseline, 2 months and 6 months post-intervention]
• SS's UE activity performance using the Motor Activity Log (MAL) [Срок оценки: Baseline, 2 months and 6 months post-intervention]
• SS's Social Participation Score using the Stroke Impact Scale (SIS) score [Срок оценки: Baseline, 2 months and 6 months post-intervention]
• CP Quality of Life [Срок оценки: Baseline, 2 months and 6 months post-intervention]
• CP Strain using the Caregiver Strain Index(CSI) [Срок оценки: Baseline, 2 months and 6 months post-intervention]

Вторичные конечные точки (6)

• SS Upper Extremity Functional capacity (ArmCAM) [Срок оценки: Baseline, 2 months and 6 months post-intervention]
• SS's Upper Extremity activity performance (accelerometry) [Срок оценки: Baseline, 2 months and 6 months post-intervention]
• Family Conflict using the Family Caregiver Conflict Scale (FCCS) score [Срок оценки: Baseline, 2 months and 6 months post-intervention]
• Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score [Срок оценки: Baseline, 2 months and 6 months post-intervention]
• Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score [Срок оценки: Baseline, 2 months and 6 months post-intervention]
• SS UE self-efficacy using the Confidence in Hand and Movement Scale (CAHM) score [Срок оценки: Baseline, 2 months and 6 months post-intervention]

Критерии участия

CarePartners (CP):

Критерии включения

• 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):

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Emory Rehabilitation Hospital — Atlanta

Идентификаторы

NCT: NCT06655402 · STUDY00007645 · R01HD115644 · 2025P010169

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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