StrokeNCT05257928
Carepartner Collaborative Integrated Therapy Gait (CARE-CITE-Gait) Program
A study testing CARE-CITE Gait in people with Stroke, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- CARE-CITE Gait
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Carepartner-Integrated Telehealth Gait Rehabilitation Program for Persons With Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- CARE-CITE Gait
- Keywords
- Telehealth, Rehabilitation, Care partner, Sub-acute stroke, CARE-CITE Gait, Stroke survivors, Caregiver
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARE-CITE GaitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CARE-CITE Gait |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month post intervention
Retention rate
Retention of participants will be tracked, recording the percentage of dropouts. Lower percentage correlates with better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month post intervention
Secondary outcomes (10)
Change in Caregiver Strain assessed by the Caregiver Strain Index (CSI)
The CSI is a 13-question tool that measures strain related to care provision with binary yes/no answers. There is at least one item for each of the following major domains: Employment, Financial, Physical, Social and Time. Scoring ranges from 0 to 13, with scores of 7 or more indicating greater level of stress.
Measured: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in Bakas Caregiving Outcomes Scale (BCOS) Score
The BCOS is a unidimensional scale based on 10 items and addresses changes in caregiving social functioning, subjective well-being and physical health. Participants respond to statements on a 7-point Likert scale (1=changed for the worst, 7=changed for the best). Total sum of items range from 15-105.
Measured: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in carepartners Family Conflict using Family Caregiver Conflict Scale (FCCS) score
The FCCS is a unidimensional, Likert-type scale composed of 15 items. Each item response is in a Likert-type format with participants indicating their agreement with the item with 1 "not true at all" to 7 "very true." Item scores are summed and higher scores represent higher levels of conflict within a family. Total scores Range 15-105
Measured: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score
The Family Care Climate Questionnaire (FCCQ) for carepartners is 14-item questionnaire asking about the carepartners' experiences with the strokes survivor in relation to their rehabilitation activities. Each item is rated on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true). Item scores are averaged to provide an overall score between 1 and 7 where higher scores indicate the carepartner thinks they are providing high autonomy support to the stroke survivor.
Measured: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score
The Family Care Climate Questionnaire (FCCQ) for stroke survivors is 14-item questionnaire asking about experiences with family members in relation to rehabilitation activities. Each item is rated on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true). Item scores are averaged to provide an overall score between 1 and 7 where higher scores indicate the stroke survivor perceives receiving high autonomy support from the carepartner.
Measured: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in lower extremity Fugl-Meyer (FM) therapist standardized assessment score
Total score is sum of 33 items. The possible score range is 0-34. Higher score correlates with less lower extremity (LE) impairment.
Measured: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in stroke survivor gait speed
The 10-meter walk test will be used, that will look at the time a standardized overground distance. Less time correlates with better outcome.
Measured: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in stroke survivor endurance
Will be assessed with the 6-minute walk test, that will look at the distance walked in 6-minutes. It is a measure of aerobic capacity and long-distance walking function. Longer distance correlates with better outcome.
Measured: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in SS Quality of Life using Stroke Impact Scale (SIS) score
Stroke Impact Scale (SIS) 59-items are broken down into eight domains: strength, hand function, mobility, activities of daily living, emotion, memory, communication, social participation. Domains are scored on a metric of 0 to 100, with higher scores indicating better self-reported health.
Measured: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in Five Times Sit-To-Stand (5TSTS) score
The Five Times Sit to Stand Test measures one aspect of transfer skill. The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.
Measured: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start18 May 2022
- Primary completion24 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc.
- Responsible party
- Principal investigator, Sarah Blanton, Emory University
- Investigators
- Sarah Blanton, PT, DPT, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257928
- Sponsor's protocol ID
- STUDY00004000
- Status last verified
- Sep 2023
- First submitted
- 11 Feb 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38001523Blanton 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.
PubMed 37090566
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Carepartner-Integrated Telehealth Gait Rehabilitation Program for Persons With Stroke
- ClinicalTrials.gov ID
- NCT05257928
- Acronym / sponsor ID
- STUDY00004000
- Conditions
- Stroke
- Keywords
- Telehealth, Rehabilitation, Care partner, Sub-acute stroke, CARE-CITE Gait, Stroke survivors, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc.
- Study start
- 18 May 2022 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARE-CITE GAIT Carepartner | Experimental | Behavioral: CARE-CITE GaitThis 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. |
| CARE-CITE GAIT Stroke Survivor | Experimental | Behavioral: CARE-CITE GaitThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARE-CITE GaitThe 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. | Behavioural | CARE-CITE GAIT Carepartner, CARE-CITE GAIT Stroke Survivor |
Primary outcome
Recruitment rate
Time frame: 1 month post intervention
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.
Retention rate
Time frame: 1 month post intervention
Retention of participants will be tracked, recording the percentage of dropouts. Lower percentage correlates with better outcome.
Carepartners adherence rate
Time frame: 1 month post intervention
Carepartners (CP) adherence will be measured by the number of modules reviewed (6 total modules). Higher number indicates better adherence.
Stroke survivors adherence rate
Time frame: 1 month post intervention
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.
Change in Post-Study System Usability Questionnaire (PSSUQ)
Time frame: Baseline, 1 month post intervention
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.
Carepartner satisfaction
Time frame: 1 month post intervention
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.
10 secondary outcomes
Change in Caregiver Strain assessed by the Caregiver Strain Index (CSI)
Time frame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in Bakas Caregiving Outcomes Scale (BCOS) Score
Time frame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in carepartners Family Conflict using Family Caregiver Conflict Scale (FCCS) score
Time frame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score
Time frame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score
Time frame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in lower extremity Fugl-Meyer (FM) therapist standardized assessment score
Time frame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in stroke survivor gait speed
Time frame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in stroke survivor endurance
Time frame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in SS Quality of Life using Stroke Impact Scale (SIS) score
Time frame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Change in Five Times Sit-To-Stand (5TSTS) score
Time frame: Baseline, 1 week post-intervention, 1 month follow up post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 38001523Blanton 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.
- Derived from this study: PubMed 37090566Blanton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Blanton, PT, DPT principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARE-CITE Gait in people with Stroke, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 month post intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05257928, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.