Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke

Stroke Clinical Trial

— CARE-CITE  

Official title:

Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703532
• Other study ID #: IRB00070957
• Secondary ID: K23HD080837
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 18, 2019

Study information

• Verified date: January 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	American Heart Association, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Primary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Primary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Primary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary	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.	Baseline, 1 Month Post-treatment (up to Week 7)
Secondary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary	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.	Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary	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.	Post-treatment (up to Week 3)