Carepartner Collaborative Integrated Therapy Gait (CARE-CITE-Gait) Program

NCT05257928 | Completed

• 1 other identifier: STUDY00004000
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Telehealth; Rehabilitation; Care partner; Sub-acute stroke; CARE-CITE Gait; Stroke survivors; Caregiver

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  Recruitment rates will be calculated based on the percentage of those participants enrolled and randomized from those screened. Recruitment will be deemed feasible if the target enrollment of 15 dyads (2-3 dyads per month) is reached during the study timeframe.

  1 month post intervention

• Retention rate

  Retention of participants will be tracked, recording the percentage of dropouts. Lower percentage correlates with better outcome.

  1 month post intervention

• Carepartners adherence rate

  Carepartners (CP) adherence will be measured by the number of modules reviewed (6 total modules). Higher number indicates better adherence.

  1 month post intervention

• Stroke survivors adherence rate

  Adherence to the stroke survivors (SS) intervention will be measured by the number of weekly sessions attended (4 total sessions) and total number of hours attended (4 hours) of training completed. Higher number correlates with better outcome.

  1 month post intervention

• Change in Post-Study System Usability Questionnaire (PSSUQ)

  The Post-Study System Usability Questionnaire will be administered to CPs at the post-treatment evaluation to gather additional data on CARE-CITE usability. The PSSUQ is a 19-item survey that measures users' perceived satisfaction with a product or system. Responses are given on a 7-point scale where 1 = strongly agree and 7 = strongly disagree. Responses are averaged to provide a total score between 1 and 7 where low answers indicate greater ease with using the CARE-CITE system.

  Baseline, 1 month post intervention

• Carepartner satisfaction

  Carepartner satisfaction will be indicated by scores on a standardized system usability assessment and CARE-CITE module-specific questionnaires. At the end of each of the six modules, carepartners (CP) will be instructed to complete these questions immediately after reviewing a module. Satisfaction will be defined as (1) usefulness of overall content, (2) usefulness of written text, (3) usefulness of videos, (4) ease of use, and (5) acceptability. Each area will be rated using a 5-point Likert type response scale ranging from 1 = strongly disagree to 5 = strongly agree and average scores calculated for each subscale as well as a total score. Total score range 1-5. Higher score correlates with better outcome.

  1 month post intervention

Secondary Outcomes (10)

• Change in Caregiver Strain assessed by the Caregiver Strain Index (CSI)

  Baseline, 1 week post-intervention, 1 month follow up post-intervention

• Change in Bakas Caregiving Outcomes Scale (BCOS) Score

  Baseline, 1 week post-intervention, 1 month follow up post-intervention

• Change in carepartners Family Conflict using Family Caregiver Conflict Scale (FCCS) score

  Baseline, 1 week post-intervention, 1 month follow up post-intervention

• Change in Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score

  Baseline, 1 week post-intervention, 1 month follow up post-intervention

• Change in Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score

  Baseline, 1 week post-intervention, 1 month follow up post-intervention

Study Arms (2)

CARE-CITE GAIT Carepartner

EXPERIMENTAL

This study arm consists of carepartners (CP) receiving the CARE-CITE Gait intervention. Over a period of one month, alongside the stroke survivor, the 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.

Behavioral: CARE-CITE Gait

CARE-CITE GAIT Stroke Survivor

EXPERIMENTAL

This study arm consists of stroke survivors (SS) of carepartners receiving the CARE-CITE Gait intervention. Over a period of one month, along with the CP, the SS 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.

Behavioral: CARE-CITE Gait

Interventions

CARE-CITE Gait BEHAVIORAL

The CARE-CITE intervention content modified to address gait rehabilitation, and test 4-weeks of CARE-CITE-Gait in 15 CP/SS dyads.It will occur in the dyad's home.CP will complete 6 online CARE-CITE modules. Modules will include demonstration videos and instructive content covering the following areas:principles of functional task practice, the adaptation of tasks, and importance of progression of challenging tasks to drive neuroplasticity. Examples are provided to address potential SS frustration and improve adherence.Underpinning the content is the concept of autonomy support,with examples of fostering empathy, problem-solving, instruction in the use of non-controlling language with role-playing situations and the importance of creating choice in activities. During the two home therapy sessions, the physical therapist will work with the CP and stroke survivor to collaboratively develop goals and an exercise program to improve mobility, gait and balance.

CARE-CITE GAIT Carepartner; CARE-CITE GAIT Stroke Survivor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Foundation for Physical Therapy, Inc.: collaborator

Study Sites (1)

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• Blanton S, Cotsonis G, Brennan K, Song R, Zajac-Cox L, Caston S, Stewart H, Jayaraman A, Reisman D, Clark PC, Kesar T. Evaluation of a carepartner-integrated telehealth gait rehabilitation program for persons with stroke: study protocol for a feasibility study. Pilot Feasibility Stud. 2023 Nov 24;9(1):192. doi: 10.1186/s40814-023-01411-1.

  PMID: 38001523 DERIVED

• Blanton S, Cotsonis G, Brenan K, Song R, Zajac-Cox L, Caston S, Stewart H, Jayaraman A, Reisman D, Clark PC, Kesar T. Evaluation of a Carepartner-Integrated Telehealth Gait Rehabilitation Program for Persons with Stroke : Study Protocol for a Feasibility Study. Res Sq [Preprint]. 2023 Apr 14:rs.3.rs-2689016. doi: 10.21203/rs.3.rs-2689016/v1.

  PMID: 37090566 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sarah Blanton, PT, DPT

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 25, 2022
• Study Start: May 18, 2022
• Primary Completion: May 24, 2023
• Study Completion: May 31, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)