Trial Outcomes & Findings for Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke (NCT NCT02703532)
NCT ID: NCT02703532
Last Updated: 2020-01-28
Results Overview
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.
COMPLETED
NA
64 participants
Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
2020-01-28
Participant Flow
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.
Participant milestones
| Measure |
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 10 sessions of constraint-induced movement therapy (CIMT).
|
Traditional Education Carepartners
Carepartners (those assisting in the care of a stroke survivor) participated in traditional education while their partner (the stroke survivor) received 10 sessions of constraint-induced movement therapy (CIMT).
|
Stroke Survivors With CARE-CITE Carepartners
Participants who have survived a stroke received 10 sessions of constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
Participants who have survived a stroke received 10 sessions of constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
11
|
21
|
11
|
|
Overall Study
COMPLETED
|
19
|
10
|
19
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
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 10 sessions of constraint-induced movement therapy (CIMT).
|
Traditional Education Carepartners
Carepartners (those assisting in the care of a stroke survivor) participated in traditional education while their partner (the stroke survivor) received 10 sessions of constraint-induced movement therapy (CIMT).
|
Stroke Survivors With CARE-CITE Carepartners
Participants who have survived a stroke received 10 sessions of constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
Participants who have survived a stroke received 10 sessions of constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
0
|
Baseline Characteristics
Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke
Baseline characteristics by cohort
| Measure |
CARE-CITE Education Program Carepartners
n=21 Participants
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).
|
Traditional Education Carepartners
n=11 Participants
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).
|
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
59.62 years
STANDARD_DEVIATION 13.49 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Wolf Motor Function Test (WMFT)
Baseline
|
12.83 seconds
Standard Deviation 2.27
|
9.38 seconds
Standard Deviation 3.14
|
|
Wolf Motor Function Test (WMFT)
Post-treatment
|
9.73 seconds
Standard Deviation 2.27
|
4.70 seconds
Standard Deviation 3.21
|
|
Wolf Motor Function Test (WMFT)
One Month Follow-up
|
8.00 seconds
Standard Deviation 2.32
|
5.18 seconds
Standard Deviation 3.21
|
PRIMARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Motor Activity Log (MAL) Score
Baseline
|
2.18 score on a scale
Standard Error 0.18
|
2.34 score on a scale
Standard Error 0.25
|
|
Motor Activity Log (MAL) Score
Post-treatment
|
3.33 score on a scale
Standard Error 0.18
|
3.59 score on a scale
Standard Error 0.26
|
|
Motor Activity Log (MAL) Score
1 Month Post-treatment Follow-up
|
3.29 score on a scale
Standard Error 0.19
|
3.39 score on a scale
Standard Error 0.26
|
PRIMARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Family Caregiver Conflict Scale (FCCS) Score
Baseline
|
28.52 score on a scale
Standard Error 2.24
|
20.00 score on a scale
Standard Error 3.10
|
|
Family Caregiver Conflict Scale (FCCS) Score
Post-treatment
|
26.95 score on a scale
Standard Error 2.24
|
21.87 score on a scale
Standard Error 3.18
|
|
Family Caregiver Conflict Scale (FCCS) Score
1 Month Post-treatment Follow-up
|
23.12 score on a scale
Standard Error 2.30
|
18.57 score on a scale
Standard Error 3.18
|
PRIMARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale (CES-D) Score
Baseline
|
8.33 score on a scale
Standard Error 1.92
|
11.64 score on a scale
Standard Error 2.65
|
|
Center for Epidemiologic Studies Depression Scale (CES-D) Score
Post-treatment
|
8.14 score on a scale
Standard Error 1.92
|
11.64 score on a scale
Standard Error 2.72
|
|
Center for Epidemiologic Studies Depression Scale (CES-D) Score
1 Month Post-treatment Follow-up
|
7.84 score on a scale
Standard Error 1.97
|
9.86 score on a scale
Standard Error 2.72
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score
Baseline
|
6.36 score on a scale
Standard Error 0.15
|
6.06 score on a scale
Standard Error 0.20
|
|
Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score
Post-treatment
|
6.39 score on a scale
Standard Error 0.15
|
6.48 score on a scale
Standard Error 0.20
|
|
Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score
1 Month Post-treatment Follow-up
|
6.54 score on a scale
Standard Error 0.15
|
6.21 score on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Fugl-Meyer Assessment (FMA) Score
Baseline
|
46.48 score on a scale
Standard Error 1.80
|
49.91 score on a scale
Standard Error 2.48
|
|
Fugl-Meyer Assessment (FMA) Score
Post-treatment
|
52.24 score on a scale
Standard Error 1.80
|
53.36 score on a scale
Standard Error 2.52
|
|
Fugl-Meyer Assessment (FMA) Score
1 Month Post-treatment Follow-up
|
52.99 score on a scale
Standard Error 1.81
|
55.46 score on a scale
Standard Error 2.51
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Confidence in Arm and Hand (CAHM) Scale Score
Baseline
|
58.45 score on a scale
Standard Error 3.96
|
50.45 score on a scale
Standard Error 5.47
|
|
Confidence in Arm and Hand (CAHM) Scale Score
Post-treatment
|
74.12 score on a scale
Standard Error 3.96
|
70.58 score on a scale
Standard Error 5.64
|
|
Confidence in Arm and Hand (CAHM) Scale Score
1 Month Post-treatment Follow-up
|
76.76 score on a scale
Standard Error 4.07
|
74.05 score on a scale
Standard Error 5.64
|
SECONDARY outcome
Timeframe: Baseline, 1 Month Post-treatment (up to Week 7)Population: This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Stroke Impact Scale (SIS) Score
SIS Strength - Baseline
|
58.33 score on a scale
Standard Error 3.26
|
51.14 score on a scale
Standard Error 4.51
|
|
Stroke Impact Scale (SIS) Score
SIS Strength - 1 Month Post-treatment
|
66.31 score on a scale
Standard Error 3.37
|
70.17 score on a scale
Standard Error 4.64
|
|
Stroke Impact Scale (SIS) Score
SIS Memory - Baseline
|
84.01 score on a scale
Standard Error 3.25
|
84.42 score on a scale
Standard Error 4.49
|
|
Stroke Impact Scale (SIS) Score
SIS Memory - 1 Month Post-treatment
|
88.09 score on a scale
Standard Error 3.36
|
88.93 score on a scale
Standard Error 4.64
|
|
Stroke Impact Scale (SIS) Score
SIS Mood - Baseline
|
62.92 score on a scale
Standard Error 2.72
|
62.63 score on a scale
Standard Error 3.76
|
|
Stroke Impact Scale (SIS) Score
SIS Mood - 1 Month Post-treatment
|
66.77 score on a scale
Standard Error 2.81
|
69.04 score on a scale
Standard Error 3.88
|
|
Stroke Impact Scale (SIS) Score
SIS Communication - Baseline
|
92.52 score on a scale
Standard Error 2.81
|
88.31 score on a scale
Standard Error 3.88
|
|
Stroke Impact Scale (SIS) Score
SIS Communication - 1 Month Post-treatment
|
92.61 score on a scale
Standard Error 2.90
|
92.54 score on a scale
Standard Error 4.01
|
|
Stroke Impact Scale (SIS) Score
SIS Activity - Baseline
|
57.51 score on a scale
Standard Error 2.40
|
54.73 score on a scale
Standard Error 3.32
|
|
Stroke Impact Scale (SIS) Score
SIS Activity - 1 Month Post-treatment
|
65.42 score on a scale
Standard Error 2.46
|
61.71 score on a scale
Standard Error 3.40
|
|
Stroke Impact Scale (SIS) Score
SIS Mobility - Baseline
|
61.59 score on a scale
Standard Error 2.97
|
52.93 score on a scale
Standard Error 4.10
|
|
Stroke Impact Scale (SIS) Score
SIS Mobility - 1 Month Post-treatment
|
67.37 score on a scale
Standard Error 3.04
|
58.65 score on a scale
Standard Error 4.20
|
|
Stroke Impact Scale (SIS) Score
SIS Affected Arm - Baseline
|
43.81 score on a scale
Standard Error 3.75
|
34.55 score on a scale
Standard Error 5.18
|
|
Stroke Impact Scale (SIS) Score
SIS Affected Arm - 1 Month Post-treatment
|
56.71 score on a scale
Standard Error 3.86
|
53.43 score on a scale
Standard Error 5.32
|
|
Stroke Impact Scale (SIS) Score
SIS Participation - Baseline
|
43.45 score on a scale
Standard Error 3.78
|
43.41 score on a scale
Standard Error 5.23
|
|
Stroke Impact Scale (SIS) Score
SIS Participation - 1 Month Post-treatment
|
53.50 score on a scale
Standard Error 3.94
|
51.88 score on a scale
Standard Error 5.43
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score
Baseline
|
12.76 score on a scale
Standard Error 2.39
|
21.91 score on a scale
Standard Error 3.30
|
|
Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score
Post-treatment
|
11.52 score on a scale
Standard Error 2.39
|
16.63 score on a scale
Standard Error 3.35
|
|
Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score
1 Month Post-treatment Follow-up
|
10.89 score on a scale
Standard Error 2.42
|
14.03 score on a scale
Standard Error 3.35
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score
Baseline
|
6.05 score on a scale
Standard Error 1.97
|
6.21 score on a scale
Standard Error 1.97
|
|
Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score
Post-treatment
|
6.15 score on a scale
Standard Error 1.97
|
6.27 score on a scale
Standard Error 1.97
|
|
Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score
1 Month Post-treatment Follow-up
|
6.13 score on a scale
Standard Error 1.97
|
6.15 score on a scale
Standard Error 1.97
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Piper Fatigue Scale (PFS) Score
Baseline
|
3.82 score on a scale
Standard Error 0.42
|
3.31 score on a scale
Standard Error 0.58
|
|
Piper Fatigue Scale (PFS) Score
Post-treatment
|
2.69 score on a scale
Standard Error 0.42
|
2.58 score on a scale
Standard Error 0.60
|
|
Piper Fatigue Scale (PFS) Score
1 Month Post-treatment Follow-up
|
2.97 score on a scale
Standard Error 0.44
|
2.34 score on a scale
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Caregiver Strain Index (CSI) Score
Baseline
|
5.52 score on a scale
Standard Error 0.69
|
4.82 score on a scale
Standard Error 0.96
|
|
Caregiver Strain Index (CSI) Score
Post-treatment
|
5.00 score on a scale
Standard Error 0.69
|
4.01 score on a scale
Standard Error 0.98
|
|
Caregiver Strain Index (CSI) Score
1 Month Post-treatment Follow-up
|
3.78 score on a scale
Standard Error 0.71
|
4.01 score on a scale
Standard Error 0.98
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Bakas Caregiving Outcomes Scale (BCOS) Score
Baseline
|
57.09 score on a scale
Standard Error 2.63
|
55.91 score on a scale
Standard Error 3.64
|
|
Bakas Caregiving Outcomes Scale (BCOS) Score
Post-treatment
|
62.71 score on a scale
Standard Error 2.63
|
59.56 score on a scale
Standard Error 3.74
|
|
Bakas Caregiving Outcomes Scale (BCOS) Score
1 Month Post-treatment Follow-up
|
61.62 score on a scale
Standard Error 2.70
|
60.62 score on a scale
Standard Error 3.74
|
SECONDARY outcome
Timeframe: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)Population: This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|
|
Caregiving Self Efficacy (Obtaining Respite Scale) Score
Baseline
|
66.44 score on a scale
Standard Error 5.77
|
68.27 score on a scale
Standard Error 7.97
|
|
Caregiving Self Efficacy (Obtaining Respite Scale) Score
Post-treatment
|
69.52 score on a scale
Standard Error 5.84
|
84.50 score on a scale
Standard Error 8.20
|
|
Caregiving Self Efficacy (Obtaining Respite Scale) Score
1 Month Post-treatment Follow-up
|
71.80 score on a scale
Standard Error 5.91
|
87.95 score on a scale
Standard Error 8.20
|
SECONDARY outcome
Timeframe: Post-treatment (up to Week 3)Population: This analysis includes carepartners who were in the CARE-CITE intervention study arm.
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.
Outcome measures
| Measure |
Stroke Survivors With CARE-CITE Carepartners
n=21 Participants
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
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.
|
|---|---|---|
|
Post Study System Usability Questionnaire (PSSUQ) Score
|
1.48 score on a scale
Standard Deviation 0.61
|
—
|
Adverse Events
CARE-CITE Education Program Carepartners
Traditional Education Carepartners
Stroke Survivors With CARE-CITE Carepartners
Stroke Survivors With Traditional Education Carepartners
Serious adverse events
| Measure |
CARE-CITE Education Program Carepartners
n=21 participants at risk
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).
|
Traditional Education Carepartners
n=11 participants at risk
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).
|
Stroke Survivors With CARE-CITE Carepartners
n=21 participants at risk
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 participants at risk
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Lower extremity cellulitis
|
0.00%
0/21 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
0.00%
0/11 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
0.00%
0/21 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
9.1%
1/11 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
Other adverse events
| Measure |
CARE-CITE Education Program Carepartners
n=21 participants at risk
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).
|
Traditional Education Carepartners
n=11 participants at risk
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).
|
Stroke Survivors With CARE-CITE Carepartners
n=21 participants at risk
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education.
|
Stroke Survivors With Traditional Education Carepartners
n=11 participants at risk
Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education.
|
|---|---|---|---|---|
|
General disorders
Fall
|
0.00%
0/21 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
0.00%
0/11 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
33.3%
7/21 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
18.2%
2/11 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
|
Vascular disorders
Heart rate increase
|
0.00%
0/21 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
0.00%
0/11 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
4.8%
1/21 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
0.00%
0/11 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
|
Nervous system disorders
Seizure
|
0.00%
0/21 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
0.00%
0/11 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
0.00%
0/21 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
9.1%
1/11 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness or pain that limits participation
|
0.00%
0/21 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
0.00%
0/11 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
4.8%
1/21 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
0.00%
0/11 • Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place