StrokeCARE-CITENCT02703532
Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke
A study testing CARE-CITE Education Program, Traditional Education and Constraint-Induced Movement Therapy (CIMT) in people with Stroke, run by Emory University at 1 site in United States.
Trial summary
The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- CARE-CITE Education Program, Traditional Education and Constraint-Induced Movement Therapy (CIMT)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 18 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke Survivors
- One month to five years post ischemic or hemorrhagic event
- Minimal to moderate upper extremity deficits (ability to initiate wrist and finger extension)
- Mini-mental screening test score of greater than 24
- Presence of a care partner
- Caregivers
Show all 9Show fewer
- At least 18 years old
- Ability to read and write English
- Mini-mental screening test score of greater than 24
Who cannot join
- Stroke Survivors
- Severe cognitive deficits
- Caregivers
- Significant cognitive deficits
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. By learning the best way to involve family members in therapy, investigators hope to decrease the harmful effects of stroke.
Read the detailed description
The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. A tablet will be provided to participants who do not have access to complete the web based intervention. All participants will be asked to complete questionnaires at the beginning of therapy, the end of therapy, and one month post therapy.
- Conditions
- Stroke
- Being tested
- CARE-CITE Education Program, Traditional Education, Constraint-Induced Movement Therapy (CIMT)
- Keywords
- Therapy, Rehabilitation, 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 Education ProgramBehavioural
CARE-CITE is an online educational program developed to provide information that may help caregivers understand more about constraint-induced movement therapy (CIMT) and their potential roles in helping the stoke survivor gain as much benefit as possible from CIMT.
If participants do not have access to a computer or tablet, they will be loaned an electronic tablet for the 2-3 week period of the study to access the information.
Participants will be asked to review six educational modules over a period of 2-3 weeks while the stroke survivor receives CIMT.
Participants will attend three in home evaluation visits; one at the beginning of the stroke survivors therapy sessions, one at the end of his/her therapy visit series, and a third evaluation one month later in which they will be asked to complete questionnaires. Evaluation visits will take approximately 1 ½ hours to complete.
Traditional EducationBehavioural
Investigators will explain constraint-induced movement therapy (CIMT) to caregivers and stroke survivors during the first home therapy session for the stroke survivor and provide traditional educational information about CIMT during therapy sessions as needed.
Constraint-Induced Movement Therapy (CIMT)Behavioural
Constraint-Induced Movement Therapy (CIMT) is one type of therapy that helps stroke survivors gain more use of their weaker arm.This therapy involves wearing a soft mitt (like a sock or oven mitt) on the stronger arm to remind the stroke survivor to use their weaker arm for daily activities and also intensive practice of tasks with the supervision of a therapist.
Participants will attend three in home evaluation visits; one at the beginning of your therapy sessions, one at the end of your therapy visit series and a third evaluation one month later. These evaluation sessions will involve an evaluation of arm function and answering three questionnaires about how well the weaker arm works and how the stroke has affected daily activities. The interview questions and assessment will take approximately 1 ½ hours to complete.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Survivors with CARE-CITE Carepartners | Experimental | Stroke survivors with a carepartner randomized to the CARE-CITE intervention. Participants who have survived a stroke will receive constraint-induced movement therapy (CIMT) while their caregiver participates in an educational program. Receives: Behavioral: Constraint-Induced Movement Therapy (CIMT) |
| CARE-CITE Education Program Carepartners | Experimental | Caregivers (someone who assists in the care of stroke survivors) will participate in online CARE-CITE education while their partner (stroke survivor) receives therapy. Receives: Behavioral: CARE-CITE Education Program |
| Traditional Education Carepartners | Active comparator | Caregivers (someone who assists in the care of stroke survivors) will participate in traditional education while their partner (stroke survivor) receives therapy. Receives: Behavioral: Traditional Education |
| Stroke Survivors with Traditional Education Carepartners | Active comparator | Stroke survivors with a carepartner randomized to receive traditional education. Participants who have survived a stroke will receive constraint-induced movement therapy (CIMT) while their caregiver participates in an educational program. Receives: Behavioral: Constraint-Induced Movement Therapy (CIMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test (WMFT)
Motor ability and impairments will be assessed using the Wolf Motor Function Test (WMFT) an assessment tool used to evaluate upper extremity performance while providing insight into joint-specific and total limb movements. Values represent the amount of time, in seconds, to complete the assessment. Lower scores (faster speed) are indicative of higher functioning levels.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Motor Activity Log (MAL) Score
Upper extremity function and use will be assessed using the Motor Activity Log (MAL). The MAL is a semi-structured interview to assess arm function. Participants are asked to rate quality of movement (QOM) during 28 daily functional tasks. Items are scored on a 6-point ordinal scale, from 0 to 5, where 0 = the affected arm was of no use and 5 = affected arm is functioning normally. 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.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Family Caregiver Conflict Scale (FCCS) Score
Family conflict will be assessed using the Family Caregiver Conflict Scale (FCCS). The FCCS is 15-item scale that measures family conflict between caregivers and other family by assessing disagreements over caring for the care recipient with items such as: "We have disagreements when I ask family members to help me take care of our relative." Items are scored from 1 to 7 where 1 = not true at all and 7 = very true. total scores range from 15 to 105 and higher scores indicate greater family conflict.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Center for Epidemiologic Studies Depression Scale (CES-D) Score
Depressive symptoms among carepartners will be assessed by the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a screening test for depression and depressive disorder. The CES-D measures the frequency and severity of 20 depressive symptoms experienced during the last week. Each item is scored from 0 to 3 where 0 = rarely and 3 = most days and certain items are reverse scored so that greater symptomatology is assigned a higher score. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression. Scores of 16 or greater are considered as an indicator of potential clinical depression.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary outcomes (11)
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 Survivor (FCCQ-SS). An autonomy supportive environment is characterized by empathy, communicating choice (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, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Fugl-Meyer Assessment (FMA) Score
Upper extremity impairment will be assessed by the Fugl-Meyer Assessment (FMA). The FMA includes 33 items that evaluate and measure recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale, from 0 to 2. Total scores range from 0 to 66 and higher scores indicates greater arm function.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Confidence in Arm and Hand (CAHM) Scale Score
Upper extremity self-efficacy will be assessed by the Confidence in Arm and Hand (CAHM) scale. The CAHM is a 20-item scale that examines self-efficacy for arm and hand function of the impaired upper extremity in individuals following stroke. Items are worded to assess task-specific self-confidence for unimanual and bilateral paretic arm and hand activities typically performed in home and community contexts. 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.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Stroke Impact Scale (SIS) Score
Quality of life will be assessed using 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 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.
Measured: Baseline, 1 Month Post-treatment (up to Week 7)
Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score
The MBPC is a 19-item caregiver-report instrument assessing observable behavioral problems in a loved one with dementia. Carepartners report how frequently problem behaviors occur on a scale from 0 to 4 where 0 = never occurs and 4 = occurs daily. Total scores range from 0 to 76, where higher scores indicate greater frequency of problematic behavior.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
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 choice (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, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Piper Fatigue Scale (PFS) Score
The Piper Fatigue Scale (PFS) is composed of 22 numerically scaled (0 to 10) items measuring four dimensions of subjective fatigue: behavioral/severity, affective meaning, sensory, and cognitive/mood. The total fatigue score is the average score for all questionnaire items and ranges from 0 to 10, where higher scores indicate greater fatigue.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Caregiver Strain Index (CSI) Score
The CSI is a 12-question instrument measuring strain related to care provision. Carepartners respond to different statements with either "yes" or "no" where yes = 1 and no = 0. Total scores range from 0 to 12 with 0 indicating no caregiver strain and 12 indicating extreme strain. Positive responses to seven or more items on the index indicate a greater level of stress related to care giving.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Bakas Caregiving Outcomes Scale (BCOS) Score
The BCOS is a 16-item scale asking about changes in the carepartner's social functioning, subjective well-being and physical health since they began caring for the stroke survivor. Participants responded to statements on a 7-point Likert scale (1=changed for the worst, 7=changed for the best). Total scores range from 16 to 112. Scores below 64 indicate that caring for the stroke survivor has resulted in negative changes, while scores above 64 indicate positive changes.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Caregiving Self Efficacy (Obtaining Respite Scale) Score
The Caregiving Self Efficacy (Obtaining Respite Scale) measures the carepartner's self-efficacy for obtaining respite from caregiving. Five items are rated on a 0-100 scale where 0 = cannot do at all, 50 = moderately certain can do, and 100 = certain can do. A total score is obtained by averaging scores for the individual items. Total scores range from 0 to 100 with higher scores indicating that the carepartner has greater confidence in keeping up with their own activities while providing care to the stroke survivor.
Measured: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Post Study System Usability Questionnaire (PSSUQ) Score
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: Post-treatment (up to Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJan 2016
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
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.
- Publications (1)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
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), American Heart Association
- Responsible party
- Principal investigator, Sarah Blanton, Emory University
- Investigators
- Sarah Blanton, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703532
- Sponsor's protocol ID
- IRB00070957
- Other IDs
- K23HD080837
- Acronym
- CARE-CITE
- Status last verified
- Jan 2020
- First submitted
- 4 Mar 2016
- Last updated
- 28 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blanton S, Clark PC, Lyles RH, Cotsonis G, Jones BD, Reiss A, Wolf SL, Dunbar S. A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2019 Apr 25;5:58. doi: 10.1186/s40814-019-0439-0. eCollection 2019.
PubMed 31057807
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke
- ClinicalTrials.gov ID
- NCT02703532
- Acronym / sponsor ID
- CARE-CITE / IRB00070957
- Conditions
- Stroke
- Keywords
- Therapy, Rehabilitation, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), American Heart Association
- Study start
- Jan 2016
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Posted 28 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. By learning the best way to involve family members in therapy, investigators hope to decrease the harmful effects of stroke.
Detailed description
The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. A tablet will be provided to participants who do not have access to complete the web based intervention. All participants will be asked to complete questionnaires at the beginning of therapy, the end of therapy, and one month post therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stroke Survivors with CARE-CITE Carepartners | Experimental | Behavioral: Constraint-Induced Movement Therapy (CIMT)Stroke survivors with a carepartner randomized to the CARE-CITE intervention. Participants who have survived a stroke will receive constraint-induced movement therapy (CIMT) while their caregiver participates in an educational program. |
| CARE-CITE Education Program Carepartners | Experimental | Behavioral: CARE-CITE Education ProgramCaregivers (someone who assists in the care of stroke survivors) will participate in online CARE-CITE education while their partner (stroke survivor) receives therapy. |
| Traditional Education Carepartners | Active comparator | Behavioral: Traditional EducationCaregivers (someone who assists in the care of stroke survivors) will participate in traditional education while their partner (stroke survivor) receives therapy. |
| Stroke Survivors with Traditional Education Carepartners | Active comparator | Behavioral: Constraint-Induced Movement Therapy (CIMT)Stroke survivors with a carepartner randomized to receive traditional education. Participants who have survived a stroke will receive constraint-induced movement therapy (CIMT) while their caregiver participates in an educational program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stroke Survivors
- One month to five years post ischemic or hemorrhagic event
- Minimal to moderate upper extremity deficits (ability to initiate wrist and finger extension)
- Mini-mental screening test score of greater than 24
- Presence of a care partner
Key exclusion criteria (4 listed)
- Stroke Survivors
- Severe cognitive deficits
- Caregivers
- 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-CITE Education ProgramCARE-CITE is an online educational program developed to provide information that may help caregivers understand more about constraint-induced movement therapy (CIMT) and their potential roles in helping the stoke survivor gain as much benefit as possible from CIMT. If participants do not have access to a computer or tablet, they will be loaned an electronic tablet for the 2-3 week period of the study to access the information. Participants will be asked to review six educational modules over a period of 2-3 weeks while the stroke survivor receives CIMT. Participants will attend three in home evaluation visits; one at the beginning of the stroke survivors therapy sessions, one at the end of his/her therapy visit series, and a third evaluation one month later in which they will be asked to complete questionnaires. Evaluation visits will take approximately 1 ½ hours to complete. | Behavioural | CARE-CITE Education Program Carepartners |
| Traditional EducationInvestigators will explain constraint-induced movement therapy (CIMT) to caregivers and stroke survivors during the first home therapy session for the stroke survivor and provide traditional educational information about CIMT during therapy sessions as needed. | Behavioural | Traditional Education Carepartners |
| Constraint-Induced Movement Therapy (CIMT)Constraint-Induced Movement Therapy (CIMT) is one type of therapy that helps stroke survivors gain more use of their weaker arm.This therapy involves wearing a soft mitt (like a sock or oven mitt) on the stronger arm to remind the stroke survivor to use their weaker arm for daily activities and also intensive practice of tasks with the supervision of a therapist. Participants will attend three in home evaluation visits; one at the beginning of your therapy sessions, one at the end of your therapy visit series and a third evaluation one month later. These evaluation sessions will involve an evaluation of arm function and answering three questionnaires about how well the weaker arm works and how the stroke has affected daily activities. The interview questions and assessment will take approximately 1 ½ hours to complete. | Behavioural | Stroke Survivors with CARE-CITE Carepartners, Stroke Survivors with Traditional Education Carepartners |
Primary outcome
Wolf Motor Function Test (WMFT)
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Motor ability and impairments will be assessed using the Wolf Motor Function Test (WMFT) an assessment tool used to evaluate upper extremity performance while providing insight into joint-specific and total limb movements. Values represent the amount of time, in seconds, to complete the assessment. Lower scores (faster speed) are indicative of higher functioning levels.
Motor Activity Log (MAL) Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Upper extremity function and use will be assessed using the Motor Activity Log (MAL). The MAL is a semi-structured interview to assess arm function. Participants are asked to rate quality of movement (QOM) during 28 daily functional tasks. Items are scored on a 6-point ordinal scale, from 0 to 5, where 0 = the affected arm was of no use and 5 = affected arm is functioning normally. 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.
Family Caregiver Conflict Scale (FCCS) Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Family conflict will be assessed using the Family Caregiver Conflict Scale (FCCS). The FCCS is 15-item scale that measures family conflict between caregivers and other family by assessing disagreements over caring for the care recipient with items such as: "We have disagreements when I ask family members to help me take care of our relative." Items are scored from 1 to 7 where 1 = not true at all and 7 = very true. total scores range from 15 to 105 and higher scores indicate greater family conflict.
Center for Epidemiologic Studies Depression Scale (CES-D) Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Depressive symptoms among carepartners will be assessed by the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a screening test for depression and depressive disorder. The CES-D measures the frequency and severity of 20 depressive symptoms experienced during the last week. Each item is scored from 0 to 3 where 0 = rarely and 3 = most days and certain items are reverse scored so that greater symptomatology is assigned a higher score. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression. Scores of 16 or greater are considered as an indicator of potential clinical depression.
11 secondary outcomes
Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Fugl-Meyer Assessment (FMA) Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Confidence in Arm and Hand (CAHM) Scale Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Stroke Impact Scale (SIS) Score
Time frame: Baseline, 1 Month Post-treatment (up to Week 7)
Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Piper Fatigue Scale (PFS) Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Caregiver Strain Index (CSI) Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Bakas Caregiving Outcomes Scale (BCOS) Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Caregiving Self Efficacy (Obtaining Respite Scale) Score
Time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Post Study System Usability Questionnaire (PSSUQ) Score
Time frame: Post-treatment (up to Week 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31057807Blanton S, Clark PC, Lyles RH, Cotsonis G, Jones BD, Reiss A, Wolf SL, Dunbar S. A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2019 Apr 25;5:58. doi: 10.1186/s40814-019-0439-0. eCollection 2019.
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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 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 Education Program, Traditional Education and Constraint-Induced Movement Therapy (CIMT) 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 9 inclusion and 4 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 28 Jan 2020. 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 28 Jan 2020). 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?
Wolf Motor Function Test (WMFT) (time frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)). The study lists 4 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 NCT02703532, which also lists 1 linked publication.
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 28 Jan 2020.