StrokeCARE-CITENCT04040751
Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke
A study testing CARE-CITE in people with Stroke, run by Emory University at 1 site in United States.
Trial summary
Carepartner and Collaborative Integrated Therapy (CARE-CITE) is a novel, web-based carepartner focused intervention designed to foster problem solving and skill building while facilitating carepartner engagement during upper extremity functional activities in the home setting. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- CARE-CITE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2019to 21 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1-3 months post ischemic or hemorrhagic event
- discharged from inpatient neurologic rehabilitation to their home
- have minimal to moderate upper extremity (UE) deficits (actively initiate 20 degrees of wrist and 10 degrees of finger extension)
- no severe cognitive deficits (Mini -mental test >24)
- no physician determined major medical problems that would limit participation in outpatient therapy
- spouse/partner or family member
Show all 12Show fewer
- dwelling in the same household
- self-identify as the primary caregiver of the stroke survivor
- >21 years old
- able to read and write English
- have no significant cognitive deficits (Mini -mental test >24)
- familiar with using a computer and accessing websites, or with using a tablet
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Carepartner and Collaborative Integrated Therapy (CARE-CITE) is a novel, web-based carepartner focused intervention designed to foster problem solving and skill building while facilitating carepartner engagement during upper extremity functional activities in the home setting. The proposed study will evaluate the application of the CARE-CITE intervention paired with usual and customary care during the sub-acute stroke.
Read the detailed description
Stroke is a leading cause of serious, long-term disability in the United States, and has a particularly harmful impact on individuals and families. Approximately 4.8 million stroke survivors require assistance from family members who are often untrained and ill prepared for the burdens associated with stroke rehabilitation. Family carepartners are key contributors to stroke recovery, but their efforts can lead them to experience a high level of burden and depressive symptoms, reduced quality of life and increased stress in the context of high levels of family conflict surrounding the recovery process. Rehabilitation therapy interventions have primarily targeted stroke survivor outcomes without specifically addressing the well-being of the carepartner.
The researchers of this study have developed a theory-based, family-centered intervention, Carepartner and Collaborative Integrated Therapy (CARE-CITE), designed to engage carepartners during stroke survivor upper extremity (UE) functional task practice in the home. Residual UE impairments occur in up to 80% of stroke survivors and are a primary factor in loss of functional independence. CARE-CITE guides the carepartner in collaborative goal setting and providing autonomy support (characterized by empathy, choice and reducing use of controlling language) for the stroke survivor to promote motivation and creative problem solving in UE self-management.
Participating stroke survivor and carepartner dyads will be randomized to receive the CARE-CITE intervention with usual customary care, or usual customary care alone for four weeks.
- Conditions
- Stroke
- Being tested
- CARE-CITE, Standard of care
- Keywords
- Telehealth, Rehabilitation, Care partner, Sub-acute stroke, CARE-CITE, Stroke survivors
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARE-CITEBehavioural
The primary CARE-CITE components will be education via web platform. Carepartners complete 6 online CARE-CITE modules (15-30-minute sessions each). The modules include demonstration videos and instructive content covering following areas: principles of functional task practice (i.e., activities of daily living such as eating, grooming, or leisure/vocational activities), adaptation of tasks, and importance of progression of challenging tasks to drive neuroplasticity (i.e., increasing numbers of practice repetitions or weight of objects lifted). 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.
Standard of careBehavioural
The carepartner will receive a support brochure with general caregiving information including website resources to mimic web interaction of intervention group (e.g., stroke caregiver resource site).
| Study group | Role | What they receive |
|---|---|---|
| CARE-CITE Carepartner | Experimental | This study arm consists of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8. Receives: Behavioral: CARE-CITE |
| Control Carepartners | Active comparator | Carepartners in this study arm receive customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The carepartner will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups. Receives: Behavioral: Standard of care |
| CARE-CITE Stroke Survivor | Experimental | This study arm consists of stroke survivors of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8. Receives: Behavioral: CARE-CITE |
| Control Stroke Survivors | Active comparator | Stroke survivors in this study arm receive customary care outpatient rehabilitation therapy but no CARE-CITE intervention. Carepartners of the stroke survivors will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups. Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners
Depression among carepartners was assessed with the CES-D. The CES-D is 20-item, 4-point Likert-type scale where 0 = none/rare and 3 = most or all of the time. The scoring of positive items is reversed. The possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Carepartner quality of life was assessed with the SF-36. The SF-36 is a 36-item Likert-type scale, mental health domain. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Lower scores indicate greater disability, while higher scores indicate less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Wolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)
The Wolf Motor Function Test (WMFT) assesses upper extremity motor ability with 17 timed and functional tasks (15 timed and 2 strength tasks). Functional ability for each task is scored from 0 to 5, where 0 = does not attempt with upper extremity being tested, and 5 = movement appears to be normal. Total scores range from 0 to 85 and lower scores indicate lower functional ability. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Wolf Motor Function Test (WMFT) Test Time Among Stroke Survivors
The Wolf Motor Function Test (WMFT) assesses upper extremity motor ability with 17 functional tasks (15 timed and 2 strength tasks). The time, in seconds, required to complete each of 15 timed scores is calculated, with lower times (faster speeds) indicating higher functioning levels. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Quality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke Survivors
The Motor Activity Log is 30-item questionnaire assessing use of the affected arm during normal daily activities. Responses are given on a Likert 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 score is the average of all items and ranges from 0 to 5, where higher values indicate greater function of the arm that was impacted by the stroke. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Quality of life among stroke survivors was assessed with the Stroke Impact Scale (SIS). The SIS is a stroke specific, self report questionnaire (59 items across 8 domains) that measures how a stroke has impacted a participant's health and life, including strength, memory and thinking, emotions and mood, communication, activities of daily living, mobility, function of affected upper extremity, and social participation. Each item is rated in a 5-point Likert scale in terms of the difficulty the participant has experienced in completing each item. A score for each domain is obtained, ranging from 0 to 100 where higher scores indicate greater ability to perform tasks. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Secondary outcomes (11)
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. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
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. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Family Caregiver Conflict Scale (FCCS) Score Among Carepartners
Family conflict was assessed among carepartners with the FCCS. The FCCS is a unidimensional, Likert scale composed of 15 items. For each item, participants indicate their agreement with the item as 1 = not true at all, to 7 = very true. Item scores are summed and total scores range from 15 to 105, where higher scores represent higher levels of conflict within a family. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Confidence in Hand and Movement Scale (CAHM) Score
Stroke survivor upper extremity self efficacy was assessed with the Confidence in Hand and Movement (CAHM) scale. The CAHM is 20-item instrument where items are scored on a scale of 0 (very uncertain) to 100 (very certain) and averaged to provide a total scale score ranging from 0 to 100. Higher scores indicate greater confidence with performing daily tasks with the impacted arm. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Family Assessment Device (FAD) Scale Score Among Carepartners
The 12-item General Family Functioning scale from the McMaster Family Assessment Device measures general family functioning. Items are scored on a 4-point scale where 1 = healthy functioning and 4 = unhealthy functioning. A total score is obtained by summing the scores and calculating the average. Higher scores indicate ineffective family functioning. Unadjusted means are presented here.
Measured: Baseline
Caregiver Strain Index (CSI) Score
The CSI is a 13-question tool that measures strain related to care provision. Questions are responded to as either "Yes" or "No" and the total score is determined by summing the "Yes" responses. Total scores range from 0 to 13 and scores of 7 or more indicate high levels of stress. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Bakas Caregiving Outcomes Scale (BCOS) Score
The BCOS is a unidimensional scale based on 15 items and addresses changes in caregiving social functioning, subjective well-being and physical health. Carepartners respond to statements on a 7-point Likert scale where 1 = changed for the worst, and 7 = changed for the best. Total scores range from 15 - 105 with higher scores representing more positive caregiving outcomes since the stroke. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Fugl-Meyer Assessment (FMA) Upper Extremity Motor Score
Upper extremity impairment was assessed by the Fugl-Meyer Assessment (FMA). The FMA evaluates and measures recovery in post-stroke hemiplegic patients with 5 domains: motor score (which is further separated for upper and lower extremity), sensation, balance, joint range of motion, and joint pain. Items are scored on a 3-point ordinal scale where 0 = cannot perform and 3 = performs fully. The total score for the upper extremity motor domain ranges from 0 to 66 and a higher score indicates greater arm function. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Neuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke Survivors
Stroke survivor quality of life and social participation was assessed by the Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities. This is an 8- item, Likert-type scale about satisfaction in the last 7 days. Neuro-QoL scores are presented as T-scores with a mean of 50 and standard deviation of 10. Scores below 50 indicate below average satisfaction with social roles and activities. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a Score
Depressive symptoms among caregivers was assessed with the 6-item PROMIS Depression - Short Form 6a instrument. Responses are given on a scale from 1 to 5 where 1 = never and 5 = always. Total scores range from 6 to 30 where higher scores indicate greater feelings of depression. Unadjusted means are presented here.
Measured: Baseline, 2 months post-intervention
Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) Score
Fine motor skills and activities of daily living (ADL) related to upper extremity function was assessed by Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL). This is an 8-item, Likert-type scale assessing the respondent's ability to perform various manual activities of daily life. Responses are given on a 5-point scale where 1 = not at all and 5 = very much. The Neuro-QoL scores are standardized as T-scores with a mean of 50 and standard deviation of 10. Scores below 50 indicate below average upper extremity function. Unadjusted means are presented here.
Measured: Baseline, 2 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 posted1 Aug 2019
- Study start9 Aug 2019
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Sarah Blanton, Emory University
- Investigators
- Sarah Blanton, PT, DPT, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040751
- Sponsor's protocol ID
- IRB00107906
- Other IDs
- R21NR018015
- Acronym
- CARE-CITE
- Status last verified
- Dec 2022
- First submitted
- 30 Jul 2019
- Last updated
- 19 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, will be shared after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke
- ClinicalTrials.gov ID
- NCT04040751
- Acronym / sponsor ID
- CARE-CITE / IRB00107906
- Conditions
- Stroke
- Keywords
- Telehealth, Rehabilitation, Care partner, Sub-acute stroke, CARE-CITE, Stroke survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 19 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Carepartner and Collaborative Integrated Therapy (CARE-CITE) is a novel, web-based carepartner focused intervention designed to foster problem solving and skill building while facilitating carepartner engagement during upper extremity functional activities in the home setting. The proposed study will evaluate the application of the CARE-CITE intervention paired with usual and customary care during the sub-acute stroke.
Detailed description
Stroke is a leading cause of serious, long-term disability in the United States, and has a particularly harmful impact on individuals and families. Approximately 4.8 million stroke survivors require assistance from family members who are often untrained and ill prepared for the burdens associated with stroke rehabilitation. Family carepartners are key contributors to stroke recovery, but their efforts can lead them to experience a high level of burden and depressive symptoms, reduced quality of life and increased stress in the context of high levels of family conflict surrounding the recovery process. Rehabilitation therapy interventions have primarily targeted stroke survivor outcomes without specifically addressing the well-being of the carepartner.
The researchers of this study have developed a theory-based, family-centered intervention, Carepartner and Collaborative Integrated Therapy (CARE-CITE), designed to engage carepartners during stroke survivor upper extremity (UE) functional task practice in the home. Residual UE impairments occur in up to 80% of stroke survivors and are a primary factor in loss of functional independence. CARE-CITE guides the carepartner in collaborative goal setting and providing autonomy support (characterized by empathy, choice and reducing use of controlling language) for the stroke survivor to promote motivation and creative problem solving in UE self-management.
Participating stroke survivor and carepartner dyads will be randomized to receive the CARE-CITE intervention with usual customary care, or usual customary care alone for four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CARE-CITE Carepartner | Experimental | Behavioral: CARE-CITEThis study arm consists of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8. |
| Control Carepartners | Active comparator | Behavioral: Standard of careCarepartners in this study arm receive customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The carepartner will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups. |
| CARE-CITE Stroke Survivor | Experimental | Behavioral: CARE-CITEThis study arm consists of stroke survivors of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8. |
| Control Stroke Survivors | Active comparator | Behavioral: Standard of careStroke survivors in this study arm receive customary care outpatient rehabilitation therapy but no CARE-CITE intervention. Carepartners of the stroke survivors will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1-3 months post ischemic or hemorrhagic event
- discharged from inpatient neurologic rehabilitation to their home
- have minimal to moderate upper extremity (UE) deficits (actively initiate 20 degrees of wrist and 10 degrees of finger extension)
- no severe cognitive deficits (Mini -mental test >24)
- no physician determined major medical problems that would limit participation in outpatient therapy
Key exclusion criteria (1 listed)
- none
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-CITEThe primary CARE-CITE components will be education via web platform. Carepartners complete 6 online CARE-CITE modules (15-30-minute sessions each). The modules include demonstration videos and instructive content covering following areas: principles of functional task practice (i.e., activities of daily living such as eating, grooming, or leisure/vocational activities), adaptation of tasks, and importance of progression of challenging tasks to drive neuroplasticity (i.e., increasing numbers of practice repetitions or weight of objects lifted). 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. | Behavioural | CARE-CITE Carepartner, CARE-CITE Stroke Survivor |
| Standard of careThe carepartner will receive a support brochure with general caregiving information including website resources to mimic web interaction of intervention group (e.g., stroke caregiver resource site). | Behavioural | Control Carepartners, Control Stroke Survivors |
Primary outcome
Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners
Time frame: Baseline, 2 months post-intervention
Depression among carepartners was assessed with the CES-D. The CES-D is 20-item, 4-point Likert-type scale where 0 = none/rare and 3 = most or all of the time. The scoring of positive items is reversed. The possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology. Unadjusted means are presented here.
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Time frame: Baseline, 2 months post-intervention
Carepartner quality of life was assessed with the SF-36. The SF-36 is a 36-item Likert-type scale, mental health domain. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Lower scores indicate greater disability, while higher scores indicate less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Unadjusted means are presented here.
Wolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)
Time frame: Baseline, 2 months post-intervention
The Wolf Motor Function Test (WMFT) assesses upper extremity motor ability with 17 timed and functional tasks (15 timed and 2 strength tasks). Functional ability for each task is scored from 0 to 5, where 0 = does not attempt with upper extremity being tested, and 5 = movement appears to be normal. Total scores range from 0 to 85 and lower scores indicate lower functional ability. Unadjusted means are presented here.
Wolf Motor Function Test (WMFT) Test Time Among Stroke Survivors
Time frame: Baseline, 2 months post-intervention
The Wolf Motor Function Test (WMFT) assesses upper extremity motor ability with 17 functional tasks (15 timed and 2 strength tasks). The time, in seconds, required to complete each of 15 timed scores is calculated, with lower times (faster speeds) indicating higher functioning levels. Unadjusted means are presented here.
Quality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke Survivors
Time frame: Baseline, 2 months post-intervention
The Motor Activity Log is 30-item questionnaire assessing use of the affected arm during normal daily activities. Responses are given on a Likert 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 score is the average of all items and ranges from 0 to 5, where higher values indicate greater function of the arm that was impacted by the stroke. Unadjusted means are presented here.
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Time frame: Baseline, 2 months post-intervention
Quality of life among stroke survivors was assessed with the Stroke Impact Scale (SIS). The SIS is a stroke specific, self report questionnaire (59 items across 8 domains) that measures how a stroke has impacted a participant's health and life, including strength, memory and thinking, emotions and mood, communication, activities of daily living, mobility, function of affected upper extremity, and social participation. Each item is rated in a 5-point Likert scale in terms of the difficulty the participant has experienced in completing each item. A score for each domain is obtained, ranging from 0 to 100 where higher scores indicate greater ability to perform tasks. Unadjusted means are presented here.
11 secondary outcomes
Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score
Time frame: Baseline, 2 months post-intervention
Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score
Time frame: Baseline, 2 months post-intervention
Family Caregiver Conflict Scale (FCCS) Score Among Carepartners
Time frame: Baseline, 2 months post-intervention
Confidence in Hand and Movement Scale (CAHM) Score
Time frame: Baseline, 2 months post-intervention
Family Assessment Device (FAD) Scale Score Among Carepartners
Time frame: Baseline
Caregiver Strain Index (CSI) Score
Time frame: Baseline, 2 months post-intervention
Bakas Caregiving Outcomes Scale (BCOS) Score
Time frame: Baseline, 2 months post-intervention
Fugl-Meyer Assessment (FMA) Upper Extremity Motor Score
Time frame: Baseline, 2 months post-intervention
Neuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke Survivors
Time frame: Baseline, 2 months post-intervention
Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a Score
Time frame: Baseline, 2 months post-intervention
Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) Score
Time frame: Baseline, 2 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, will be shared after deidentification (text, tables, figures, and appendices).
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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 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 12 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: finished, as of the sponsor's last update on 19 Jan 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?
Yes. Results are posted in the registry (first posted 19 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners (time frame: Baseline, 2 months 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?
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 19 Jan 2023.