Clinical trial NCT05257928: Carepartner Collaborative Integrated Therapy Gait (CARE-CITE-Gait) Program
Official title: Evaluation of a Carepartner-Integrated Telehealth Gait Rehabilitation Program for Persons With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Telehealth
Rehabilitation
Care partner
Sub-acute stroke
CARE-CITE Gait
Stroke survivors
Caregiver
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy, Inc.
First posted: 2022-02-25
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke affects both the carepartner (CP) and stroke survivor (SS), with CPs frequently feeling overwhelmed and exhausted. The investigators have developed a theory-based, family-centered intervention, Carepartner Collaborative Integrated Therapy (CARE-CITE) designed to positively engage CPs during SS daily activities and rehabilitation exercise practice in the home setting. Using a web-based program with exemplary interactive videos of family scenarios in the home, CARE-CITE guides the CP in collaborative goal setting and creating an autonomy-supportive environment with the SS to promote motivation and creative problem-solving.

This study will use the modified upper extremity-focused CARE-CITE intervention content to address gait rehabilitation, and test 4-weeks of CARE-CITE-Gait in 15 CP/SS dyads to determine if similar positive outcomes are seen with integration to gait rehabilitation. Over a period of one month, SS and CP will receive 2 two-hour home-based therapy visits with a licensed physical therapist to develop therapy goals related to gait, mobility and balance and develop a home exercise plan to improve function. The CP will receive two additional phone calls to discuss the online CARE-CITE educational modules. The overall impact of this work is the development of innovative family-centered telerehabilitation interventions to improve self-management and physical activity.

Detailed description: Stroke affects both the carepartner (CP) and stroke survivor (SS), with CPs frequently feeling overwhelmed and exhausted. Rehabilitation therapy activities largely do not address CP's well-being. The investigators have developed a theory-based, family-centered intervention, Carepartner Collaborative Integrated Therapy (CARE-CITE) designed to positively engage CPs during SS daily activities and rehabilitation exercise practice in the home setting. Using a web-based program with exemplary interactive videos of family scenarios in the home, CARE-CITE guides the CP in collaborative goal setting and creating an autonomy-supportive environment with the SS to promote motivation and creative problem-solving. To date, CARE-CITE has been evaluated in SS with chronic stroke and coupled with upper extremity therapy interventions. Promising preliminary data showed improvement in CP psychosocial outcomes and SS upper extremity function. The potential impact of CARE-CITE on SS mobility and gait recovery is unknown.

The investigators now seek to broaden the scope of the intervention by pairing CARE-CITE with home-based gait and functional mobility training (CARE-CITE-Gait). The goal of this proposal is to assess the impact of a novel home-based CARE-CITE-Gait intervention using a user-friendly telehealth delivery system. Aim 1 will evaluate usability, acceptability, and feasibility of CARE-CITE-Gait. Aim 2 will use a single site, quasi-experimental design with repeated measures (two baseline visits, post, and 1-month follow-up) to test 4-weeks of CARE-CITE-Gait in 15 CP/SS dyads to determine if similar positive outcomes are seen. Wearable sensors will be used to evaluate physical activity within the home and community. These data will support a larger randomized controlled trial testing the CARE-CITE-Gait intervention.

Study participants will be identified and recruited with successful techniques established by the PI (Blanton) and Co-I (Kesar) 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 upon study inclusion/exclusion criteria and contacted by the research coordinator, if eligible. Participant eligibility will be confirmed via telephone screen, and initial clinical evaluation will follow at the Emory Rehabilitation Clinic. Eligible dyads (CP and SS) will be consented and evaluated at Emory Rehabilitation Hospital. Administration of CARE-CITE Gait intervention will occur in participants' homes over a period of 4 weeks, which includes CP review of the online CARE-CITE Gait education modules, two 2-hour home visits and 2 telerehabilitation check in video conference calls. All dyads will receive compensation for study participation at the end of the 1-month follow-up or prorated based on completed study evaluations.

The overall impact of this work is the development of innovative family-centered telerehabilitation interventions to improve self-management and physical activity. By providing a family-focused approach to gait and physical activity interventions, this project will help develop more effective treatments that improve both carepartner and stroke survivor outcomes after stroke.

Eligibility criteria: Inclusion Criteria:

* All SSs will be \>3 months post-ischemic or hemorrhagic event, discharged from inpatient neurologic rehabilitation to their home, able to walk 10-meters with or without an assistive device, no severe cognitive deficits, no physician determined major medical or musculoskeletal problems that would limit participation, and a CP living in the home.
* CPs must be \>21 years old, able to read and write English and have no significant cognitive deficits. CPs will be defined as those individuals who are a spouse/partner or family member dwelling in the same household. CPs must be familiar with using a computer and accessing websites or be familiar with using a tablet (available for loan if no computer is available).

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Cognitively impaired or Individuals with Impaired Decision-Making Capacity
* Individuals who are not able to clearly understand English
* Community Participation

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 month post intervention
measure: Retention rate
timeFrame: 1 month post intervention
measure: Carepartners adherence rate
timeFrame: 1 month post intervention
measure: Stroke survivors adherence rate
timeFrame: 1 month post intervention
measure: Change in Post-Study System Usability Questionnaire (PSSUQ)
timeFrame: Baseline, 1 month post intervention
measure: Carepartner satisfaction
timeFrame: 1 month post intervention
Secondary outcomes:
measure: Change in Caregiver Strain assessed by the Caregiver Strain Index (CSI)
timeFrame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
measure: Change in Bakas Caregiving Outcomes Scale (BCOS) Score
timeFrame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
measure: Change in carepartners Family Conflict using Family Caregiver Conflict Scale (FCCS) score
timeFrame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
measure: Change in Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score
timeFrame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
measure: Change in Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score
timeFrame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
measure: Change in lower extremity Fugl-Meyer (FM) therapist standardized assessment score
timeFrame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
measure: Change in stroke survivor gait speed
timeFrame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
measure: Change in stroke survivor endurance
timeFrame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
measure: Change in SS Quality of Life using Stroke Impact Scale (SIS) score
timeFrame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
measure: Change in Five Times Sit-To-Stand (5TSTS) score
timeFrame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Sarah Blanton, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: