Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655402
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons with Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons with Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE-CITE
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 inclusionexclusion 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 participants enrollment in the study will last 29 weeks All study visits will be virtual Over 4 study evaluation sessions 2hrsdyad 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 survivors 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
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 inclusionexclusion 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 participants enrollment in the study will last 29 weeks All study visits will be virtual Over 4 study evaluation sessions 2hrsdyad 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 survivors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None