Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke (CARE-CITE)

• ClinicalTrials.gov Identifier: NCT02703532
• Recruitment Status: Completed
• First Posted: March 9, 2016
• Results First Posted: January 28, 2020
• Last Update Posted: January 28, 2020
• Sponsor: Emory University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); American Heart Association
• Information provided by (Responsible Party): Sarah Blanton, Emory University

Study Description

Brief 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). 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.

Condition or disease	Intervention/treatment	Phase
Stroke	Behavioral: CARE-CITE Education Program; Behavioral: Traditional Education; Behavioral: Constraint-Induced Movement Therapy (CIMT)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke
• Study Start Date: January 2016
• Actual Primary Completion Date: January 18, 2019
• Actual Study Completion Date: January 18, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Stroke Survivors with CARE-CITE Carepartners; 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.	Behavioral: 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.
Experimental: CARE-CITE Education Program Carepartners; Caregivers (someone who assists in the care of stroke survivors) will participate in online CARE-CITE education while their partner (stroke survivor) receives therapy.	Behavioral: CARE-CITE Education Program; 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.
Active Comparator: Traditional Education Carepartners; Caregivers (someone who assists in the care of stroke survivors) will participate in traditional education while their partner (stroke survivor) receives therapy.	Behavioral: Traditional Education; 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.
Active Comparator: Stroke Survivors with Traditional Education Carepartners; 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. 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) ]
   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.
2. Fugl-Meyer Assessment (FMA) Score [ Time Frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7) ]
   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.
3. 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) ]
   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.
4. Stroke Impact Scale (SIS) Score [ Time Frame: Baseline, 1 Month Post-treatment (up to Week 7) ]
   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.
5. 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) ]
   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.
6. 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) ]
   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.
7. Piper Fatigue Scale (PFS) Score [ Time Frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7) ]
   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.
8. Caregiver Strain Index (CSI) Score [ Time Frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7) ]
   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.
9. Bakas Caregiving Outcomes Scale (BCOS) Score [ Time Frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7) ]
   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.
10. Caregiving Self Efficacy (Obtaining Respite Scale) Score [ Time Frame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7) ]
    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.
11. Post Study System Usability Questionnaire (PSSUQ) Score [ Time Frame: Post-treatment (up to Week 3) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

• At least 18 years old
• Ability to read and write English
• Mini-mental screening test score of greater than 24

Exclusion Criteria:

Stroke Survivors

• Severe cognitive deficits

Caregivers

• Significant cognitive deficits

Contacts and Locations

Locations

United States, Georgia

Emory University Hospital

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

American Heart Association

Investigators

• Principal Investigator: Sarah Blanton; Emory University

  Study Documents (Full-Text)

Documents provided by Sarah Blanton, Emory University:

Study Protocol and Statistical Analysis Plan  [PDF] October 4, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sarah Blanton, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02703532
• Other Study ID Numbers: IRB00070957; K23HD080837 ( U.S. NIH Grant/Contract )
• First Posted: March 9, 2016
• Results First Posted: January 28, 2020
• Last Update Posted: January 28, 2020
• Last Verified: January 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sarah Blanton, Emory University:

Therapy; Rehabilitation; Caregiver

Additional relevant MeSH terms:

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