StrokeCARE-CITENCT06655402
Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons With Stroke
A study testing CARE-CITE and Actigraph GT3X+ in people with Stroke and Caregiver Burden, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Caregiver Burden
- What is being tested?
- CARE-CITE and Actigraph GT3X+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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):
- Must be at least18 years old
Show all 11Show fewer
- 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
Who cannot join
- Significant cognitive deficits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory Rehabilitation Hospital
Atlanta, Georgia, 30322
About this study
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.
Read the 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 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.
- Conditions
- Stroke, Caregiver Burden
- Being tested
- CARE-CITE, Attention Control Group, Actigraph GT3X+
- Keywords
- Stroke Survivors, Carepartners, Caregivers, Post-Stroke Recovery, Telehealth, Rehabilitation
- Medical subject headings
- Stroke, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARE-CITEBehavioural
Also called Carepartner and Collaborative Integrated Therapy
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 initial visit, CPs review online modules, set collaborative goals, and co-create a home exercise plan targeting upper extremity (UE) activities. The second and third weeks involve structured phone calls to discuss autonomy-supportive strategies and address challenges.
The final visit reinforces strategies, assesses SS progress, and adjusts rehabilitation goals. Each module is designed to foster motivation and effective practice in daily activities.
Attention Control GroupBehavioural
Also called 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 flexibility, strength, and coordination (6-8 exercises, 2 sets of 10 reps). SS will be encouraged to practice daily (targeting 30 min/day). Weeks 2 and 3: CP Phone check-ins [15-minute]. The intervention therapist will review safety, assess adverse events, and CP's use of web resources. Week 4 Virtual Home visit (2 hours). Review SS's progress with the UE activity home exercise program, discuss safety concerns, and progress UE exercises as appropriate.
Actigraph GT3X+Other
Also called Accelerometry
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 situations where quantifiable analysis of physical motion is needed.
| Study group | Role | What they receive |
|---|---|---|
| CARE-CITE- CarePartners (Intervention Group) | Experimental | The CP will receive virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program. Receives: Behavioral: CARE-CITE |
| CARE-CITE- Stroke Survivors (Intervention Group) | Experimental | This study arm consists of stroke survivors (SS) of carepartners receiving the virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program. Receives: Behavioral: CARE-CITE; Other: Actigraph GT3X+ |
| Attention Control Group-CarePartners | Active comparator | CP in this group will receive traditional written family educational materials to review during the 4-week intervention period. Receives: Behavioral: Attention Control Group |
| Attention Control Group-Stroke Survivors | Active comparator | This study arm consists of stroke survivors (SS) of carepartners receiving the traditional written family educational materials to review during the 4-week intervention period. Receives: Behavioral: Attention Control Group; Other: Actigraph GT3X+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
SS's Upper Extremity Functional Capacity
Upper Extremity Fugl Meyer (FM) therapist standardized assessment. Total score=sum of 33 items; range 0-66 higher score, less UE impairment.
Measured: Baseline, 2 months and 6 months post-intervention
SS's UE activity performance using the Motor Activity Log (MAL)
MAL, a 30-item questionnaire, Likert-type scale, assessing the use of the affected arm during normal daily activities. Responses are given on a Likert-type scale where 0= the weaker arm was not used at all for that activity (never) to 5=the ability to use the weaker arm for that activity was as good as before the stroke (normal). The total scores are the average of all items and range from 0 to 5, where higher values indicate the greater function of the arm impacted by the stroke. A high score/high-quality UE use.
Measured: Baseline, 2 months and 6 months post-intervention
SS's Social Participation Score using the Stroke Impact Scale (SIS) score
Stroke Impact Scale (SIS), is a stroke-specific self-report questionnaire (59 items across 8 domains) that measures how a stroke has impacted a participant's health. The Social Participation Domain: rated in a 5-point Likert scale regarding the difficulty the participant has experienced completing each item (range 0-100). Higher scores, higher social participation.
Measured: Baseline, 2 months and 6 months post-intervention
CP Quality of Life
CP will complete the Bakas Caregiving Outcomes Scale (BCOS). BCOS is a unidimensional scale based on 15 items and addresses changes in caregiving social functioning, subjective well-being, and physical health. Participants respond to statements on a 7-point Likert scale (-3 =changed for the worst, +3 = changed for the best, with 0 meaning did not change). The -3 to +3 ratings are recoded to 1-7 so positive numbers used for analysis. Total BCOS score ranges from 15-105. A Cut-off score >60 = positive life changes. Higher scores, better caregiving outcomes.
Measured: Baseline, 2 months and 6 months post-intervention
CP Strain using the Caregiver Strain Index(CSI)
Caregiver Strain Index (CSI), self-reported. A 13-question tool that measures strain related to care provision with binary yes/no answers. There is at least one item for each major domain: Employment, Financial, Physical, Social, and Time. Scoring ranges from 0 to 13, with scores of 7 or more indicating a greater level of stress. Higher scores, more strain.
Measured: Baseline, 2 months and 6 months post-intervention
Secondary outcomes (6)
SS Upper Extremity Functional capacity (ArmCAM)
Arm Capacity and Movement Test (ArmCAM). A therapist standardized assessment. A 10-item scale (range = 0-30); designed specifically to evaluate UE motor function virtually by videoconferencing.
Measured: Baseline, 2 months and 6 months post-intervention
SS's Upper Extremity activity performance (accelerometry)
Accelerometers will be worn for all activities over 3-7 days except for water-based activities. These activities include activities of daily living. Accelerometry data will be gathered via Actigraph GT3X+ wearable sensors per FDA definition and approval of device use. After the virtual baseline (T0) data collection visit, the blinded data collector (licensed physical or occupational therapist) will review the accelerometer procedures with the dyad, confirm proper donning and UE wrist placement of the devices, and wear-time of 3-7 days.
Measured: Baseline, 2 months and 6 months post-intervention
Family Conflict using the 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, 2 months and 6 months post-intervention
Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score
Autonomy support for carepartners will be assessed by the Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale. An autonomy-supportive environment is characterized by empathy, communicating choices (avoiding controlling language), providing rationales and problem-solving. Questions are asked about the carepartner's perspective on how much they provide an autonomy supportive environment for the stroke survivor. The FCCQ-CP includes 14 items scored from 1 to 7 where 1 = not true at all and 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, 2 months and 6 months post-intervention
Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score
Autonomy support will be assessed using the Autonomy Support Family Care Climate Questionnaire for Stroke Survivors (FCCQ-SS). An autonomy-supportive environment is characterized by empathy, communicating choices (avoiding controlling language), providing rationales, and problem-solving. Questions are asked about the stroke survivor's perspective on how much the carepartner provides an autonomy-supportive environment for the stroke survivor. The FCCQ-SS includes 14 items scored from 1 to 7 where 1 = not true at all and 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, 2 months and 6 months post-intervention
SS UE self-efficacy using the Confidence in Hand and Movement Scale (CAHM) score
Stroke survivor UE self-efficacy will be assessed with the CAHM Scale. The CAHM is a 20-item questionnaire where the items are scored on a scale of 0 (very uncertain) to 100 (very certain) and averaged to provide a total score ranging from 0-100; higher scores indicate greater confidence in performing daily tasks with the impacted arm.
Measured: Baseline, 2 months and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start25 Mar 2025
- Primary completionFeb 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sarah Blanton, Emory University
- Investigators
- Sarah Blanton, PT, DPT, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655402
- Sponsor's protocol ID
- STUDY00007645
- Other IDs
- R01HD115644, 2025P010169
- Acronym
- CARE-CITE
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigator will share de-identified participant-level data in both raw and pre-processed forms on NICHD DASH to facilitate replication and validation of findings associated with each aim.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons With Stroke
- ClinicalTrials.gov ID
- NCT06655402
- Acronym / sponsor ID
- CARE-CITE / STUDY00007645
- Conditions
- Stroke, Caregiver Burden
- Keywords
- Stroke Survivors, Carepartners, Caregivers, Post-Stroke Recovery, Telehealth, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 23 Oct 2024 (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 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CARE-CITE- CarePartners (Intervention Group) | Experimental | Behavioral: CARE-CITEThe CP will receive virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program. |
| CARE-CITE- Stroke Survivors (Intervention Group) | Experimental | Behavioral: CARE-CITE, Other: Actigraph GT3X+This study arm consists of stroke survivors (SS) of carepartners receiving the virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program. |
| Attention Control Group-CarePartners | Active comparator | Behavioral: Attention Control GroupCP in this group will receive traditional written family educational materials to review during the 4-week intervention period. |
| Attention Control Group-Stroke Survivors | Active comparator | Behavioral: Attention Control Group, Other: Actigraph GT3X+This study arm consists of stroke survivors (SS) of carepartners receiving the traditional written family educational materials to review during the 4-week intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Must be at least18 years old
Key exclusion criteria (1 listed)
- Significant cognitive deficits
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-CITEAlso: Carepartner and Collaborative Integrated TherapyCARE-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 initial visit, CPs review online modules, set collaborative goals, and co-create a home exercise plan targeting upper extremity (UE) activities. The second and third weeks involve structured phone calls to discuss autonomy-supportive strategies and address challenges. The final visit reinforces strategies, assesses SS progress, and adjusts rehabilitation goals. Each module is designed to foster motivation and effective practice in daily activities. | Behavioural | CARE-CITE- CarePartners (Intervention Group), CARE-CITE- Stroke Survivors (Intervention Group) |
| Attention Control GroupAlso: Control GroupOver 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 flexibility, strength, and coordination (6-8 exercises, 2 sets of 10 reps). SS will be encouraged to practice daily (targeting 30 min/day). Weeks 2 and 3: CP Phone check-ins [15-minute]. The intervention therapist will review safety, assess adverse events, and CP's use of web resources. Week 4 Virtual Home visit (2 hours). Review SS's progress with the UE activity home exercise program, discuss safety concerns, and progress UE exercises as appropriate. | Behavioural | Attention Control Group-CarePartners, Attention Control Group-Stroke Survivors |
| Actigraph GT3X+Also: AccelerometryAccelerometry 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 situations where quantifiable analysis of physical motion is needed. | Other | Attention Control Group-Stroke Survivors, CARE-CITE- Stroke Survivors (Intervention Group) |
Primary outcome
SS's Upper Extremity Functional Capacity
Time frame: Baseline, 2 months and 6 months post-intervention
Upper Extremity Fugl Meyer (FM) therapist standardized assessment. Total score=sum of 33 items; range 0-66 higher score, less UE impairment.
SS's UE activity performance using the Motor Activity Log (MAL)
Time frame: Baseline, 2 months and 6 months post-intervention
MAL, a 30-item questionnaire, Likert-type scale, assessing the use of the affected arm during normal daily activities. Responses are given on a Likert-type scale where 0= the weaker arm was not used at all for that activity (never) to 5=the ability to use the weaker arm for that activity was as good as before the stroke (normal). The total scores are the average of all items and range from 0 to 5, where higher values indicate the greater function of the arm impacted by the stroke. A high score/high-quality UE use.
SS's Social Participation Score using the Stroke Impact Scale (SIS) score
Time frame: Baseline, 2 months and 6 months post-intervention
Stroke Impact Scale (SIS), is a stroke-specific self-report questionnaire (59 items across 8 domains) that measures how a stroke has impacted a participant's health. The Social Participation Domain: rated in a 5-point Likert scale regarding the difficulty the participant has experienced completing each item (range 0-100). Higher scores, higher social participation.
CP Quality of Life
Time frame: Baseline, 2 months and 6 months post-intervention
CP will complete the Bakas Caregiving Outcomes Scale (BCOS). BCOS is a unidimensional scale based on 15 items and addresses changes in caregiving social functioning, subjective well-being, and physical health. Participants respond to statements on a 7-point Likert scale (-3 =changed for the worst, +3 = changed for the best, with 0 meaning did not change). The -3 to +3 ratings are recoded to 1-7 so positive numbers used for analysis. Total BCOS score ranges from 15-105. A Cut-off score >60 = positive life changes. Higher scores, better caregiving outcomes.
CP Strain using the Caregiver Strain Index(CSI)
Time frame: Baseline, 2 months and 6 months post-intervention
Caregiver Strain Index (CSI), self-reported. A 13-question tool that measures strain related to care provision with binary yes/no answers. There is at least one item for each major domain: Employment, Financial, Physical, Social, and Time. Scoring ranges from 0 to 13, with scores of 7 or more indicating a greater level of stress. Higher scores, more strain.
6 secondary outcomes
SS Upper Extremity Functional capacity (ArmCAM)
Time frame: Baseline, 2 months and 6 months post-intervention
SS's Upper Extremity activity performance (accelerometry)
Time frame: Baseline, 2 months and 6 months post-intervention
Family Conflict using the Family Caregiver Conflict Scale (FCCS) score
Time frame: Baseline, 2 months and 6 months post-intervention
Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score
Time frame: Baseline, 2 months and 6 months post-intervention
Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score
Time frame: Baseline, 2 months and 6 months post-intervention
SS UE self-efficacy using the Confidence in Hand and Movement Scale (CAHM) score
Time frame: Baseline, 2 months and 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. The investigator will share de-identified participant-level data in both raw and pre-processed forms on NICHD DASH to facilitate replication and validation of findings associated with each aim.
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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.
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 and Actigraph GT3X+ in people with Stroke and Caregiver Burden, 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 11 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah R Blanton, PT, DPT ((404) 712-2222, sblanto@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SS's Upper Extremity Functional Capacity (time frame: Baseline, 2 months and 6 months post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.