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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02703532

Acronym

CARE-CITE

Enrollment

Registered

2016-03-09

Start date

2016-01-31

Completion date

2019-01-18

Last updated

2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Therapy, Rehabilitation, Caregiver

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.

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.

Interventions

BEHAVIORALCARE-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.

BEHAVIORALTraditional 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.

BEHAVIORALConstraint-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Wolf Motor Function Test (WMFT)	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	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	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	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

Measure	Time frame	Description
Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score	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.
Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score	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.
Piper Fatigue Scale (PFS) Score	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.
Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score	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.
Bakas Caregiving Outcomes Scale (BCOS) Score	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.
Caregiving Self Efficacy (Obtaining Respite Scale) Score	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.
Post Study System Usability Questionnaire (PSSUQ) Score	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.
Caregiver Strain Index (CSI) Score	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.
Fugl-Meyer Assessment (FMA) Score	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.
Confidence in Arm and Hand (CAHM) Scale Score	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.
Stroke Impact Scale (SIS) Score	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.

Countries

United States

Participant flow

Recruitment details

Participant enrollment began in January 2016 and all study follow up was completed on January 8, 2019. Participants were enrolled at Emory University Hospital in Atlanta, Georgia.

Participants by arm

Arm	Count
CARE-CITE Education Program Carepartners Carepartners (those assisting in the care of a stroke survivor) participated in online CARE-CITE education while their partner (the stroke survivor) received constraint-induced movement therapy (CIMT).	21
Traditional Education Carepartners Carepartners (those assisting in the care of a stroke survivor) participated in traditional education while their partner (the stroke survivor) received constraint-induced movement therapy (CIMT).	11
Stroke Survivors With CARE-CITE Carepartners Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.	21
Stroke Survivors With Traditional Education Carepartners Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.	11
Total	64

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	2	0	2	0
Overall Study	Withdrawal by Subject	0	1	0	1

Baseline characteristics

Characteristic	CARE-CITE Education Program Carepartners	Total	Stroke Survivors With Traditional Education Carepartners	Stroke Survivors With CARE-CITE Carepartners	Traditional Education Carepartners
Age, Continuous	56.5 years STANDARD_DEVIATION 12.6	59.62 years STANDARD_DEVIATION 13.49	63.3 years STANDARD_DEVIATION 11.3	59.2 years STANDARD_DEVIATION 15.3	60.1 years STANDARD_DEVIATION 14
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants	63 Participants	11 Participants	21 Participants	11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	8 Participants	25 Participants	4 Participants	9 Participants	4 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	12 Participants	37 Participants	7 Participants	11 Participants	7 Participants
Region of Enrollment United States	21 Participants	64 Participants	11 Participants	21 Participants	11 Participants
Sex: Female, Male Female	14 Participants	34 Participants	5 Participants	9 Participants	6 Participants
Sex: Female, Male Male	7 Participants	30 Participants	6 Participants	12 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 11	0 / 21	0 / 11
other Total, other adverse events	0 / 21	0 / 11	9 / 21	3 / 11
serious Total, serious adverse events	0 / 21	0 / 11	0 / 21	1 / 11

Outcome results

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.