Trial Outcomes & Findings for Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke (NCT NCT04040751)
NCT ID: NCT04040751
Last Updated: 2023-01-19
Results Overview
Depression among carepartners was assessed with the CES-D. The CES-D is 20-item, 4-point Likert-type scale where 0 = none/rare and 3 = most or all of the time. The scoring of positive items is reversed. The possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology. Unadjusted means are presented here.
COMPLETED
NA
46 participants
Baseline, 2 months post-intervention
2023-01-19
Participant Flow
Participant enrollment began August 9, 2019 and all follow up was complete by December 21, 2021. Participants were enrolled from Emory Hospital in Atlanta, Georgia, USA.
Participant milestones
| Measure |
CARE-CITE Carepartner
This study arm consists of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8.
|
Control Carepartners
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The carepartner will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups.
|
CARE-CITE Stroke Survivor
This study arm consists of stroke survivors of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8.
|
Control Stroke Survivors
Stroke survivors receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The carepartner of the stroke survivor will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
6
|
17
|
6
|
|
Overall Study
COMPLETED
|
15
|
6
|
15
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
CARE-CITE Carepartner
This study arm consists of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8.
|
Control Carepartners
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The carepartner will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups.
|
CARE-CITE Stroke Survivor
This study arm consists of stroke survivors of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8.
|
Control Stroke Survivors
Stroke survivors receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The carepartner of the stroke survivor will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
0
|
Baseline Characteristics
Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke
Baseline characteristics by cohort
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
CARE-CITE Stroke Survivor
n=17 Participants
Stroke survivors of carepartners receiving the CARE-CITE intervention
|
Control Stroke Survivors
n=6 Participants
Stroke survivors receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
58.1 years
STANDARD_DEVIATION 13.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 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
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 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
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Education
High school or less
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Education
1-3 years of college
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Education
4 or more years of college
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 months post-interventionDepression among carepartners was assessed with the CES-D. The CES-D is 20-item, 4-point Likert-type scale where 0 = none/rare and 3 = most or all of the time. The scoring of positive items is reversed. The possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners
Baseline
|
9.9 score on a scale
Standard Deviation 9.7
|
11.2 score on a scale
Standard Deviation 8.5
|
|
Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners
2 Months Post-intervention
|
9.1 score on a scale
Standard Deviation 8.2
|
9.3 score on a scale
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Baseline, 2 months post-interventionCarepartner quality of life was assessed with the SF-36. The SF-36 is a 36-item Likert-type scale, mental health domain. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Lower scores indicate greater disability, while higher scores indicate less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Physical Functioning - Baseline
|
73.9 score on a scale
Standard Deviation 21.6
|
92.5 score on a scale
Standard Deviation 8.2
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Physical Functioning - 2 Months Post-intervention
|
82.3 score on a scale
Standard Deviation 13.1
|
85.8 score on a scale
Standard Deviation 15.6
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Role Limitation, Physical - Baseline
|
70.6 score on a scale
Standard Deviation 42.6
|
83.3 score on a scale
Standard Deviation 20.4
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Role Limitation, Physical - 2 Months Post-intervention
|
76.7 score on a scale
Standard Deviation 38.3
|
70.8 score on a scale
Standard Deviation 45.9
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Role Limitation, Emotional - Baseline
|
70.6 score on a scale
Standard Deviation 30.4
|
91.7 score on a scale
Standard Deviation 13.9
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Role Limitation, Emotional - 2 Months Post-intervention
|
82.2 score on a scale
Standard Deviation 18.3
|
83.3 score on a scale
Standard Deviation 14.9
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Energy/Vitality - Baseline
|
58.2 score on a scale
Standard Deviation 21.1
|
47.5 score on a scale
Standard Deviation 27.2
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Energy/Vitality - 2 Months Post-intervention
|
64.0 score on a scale
Standard Deviation 16.4
|
55.0 score on a scale
Standard Deviation 28.1
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Emotional Well Being - Baseline
|
74.6 score on a scale
Standard Deviation 18.9
|
74.0 score on a scale
Standard Deviation 12.3
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Emotional Well Being - 2 Months Post-intervention
|
76.3 score on a scale
Standard Deviation 16.0
|
81.3 score on a scale
Standard Deviation 12.8
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Social Functioning - Baseline
|
76.5 score on a scale
Standard Deviation 22.5
|
83.3 score on a scale
Standard Deviation 30.3
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Social Functioning - 2 Months Post-intervention
|
83.3 score on a scale
Standard Deviation 23.5
|
83.3 score on a scale
Standard Deviation 21.9
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Pain - Baseline
|
81.0 score on a scale
Standard Deviation 16.8
|
78.8 score on a scale
Standard Deviation 13.9
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
Pain - 2 Months Post-intervention
|
77.2 score on a scale
Standard Deviation 22.6
|
73.8 score on a scale
Standard Deviation 31.7
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
General Health - Baseline
|
67.4 score on a scale
Standard Deviation 10.5
|
72.5 score on a scale
Standard Deviation 7.6
|
|
Short Form Health Survey (SF-36) Scale Score Among Carepartners
General Health - 2 Months Post-intervention
|
71.0 score on a scale
Standard Deviation 9.7
|
76.7 score on a scale
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: Baseline, 2 months post-interventionPopulation: The WMFT is an in-person assessment and administration of the WMFT was stopped after the study converted to fully remote delivery due to Coronavirus Disease 2019 (COVID-19) pandemic health restrictions which limited in-person visits. This analysis includes participants who completed the WMFT assessment prior to the study being conducted remotely.
The Wolf Motor Function Test (WMFT) assesses upper extremity motor ability with 17 timed and functional tasks (15 timed and 2 strength tasks). Functional ability for each task is scored from 0 to 5, where 0 = does not attempt with upper extremity being tested, and 5 = movement appears to be normal. Total scores range from 0 to 85 and lower scores indicate lower functional ability. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=5 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=2 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)
Baseline
|
59.0 score on a scale
Standard Deviation 3.9
|
43.0 score on a scale
Standard Deviation 5.7
|
|
Wolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)
2 Months Post-intervention
|
59.5 score on a scale
Standard Deviation 7.8
|
55.5 score on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Baseline, 2 months post-interventionPopulation: The WMFT is an in-person assessment and administration of the WMFT was stopped after the study converted to fully remote delivery due to Coronavirus Disease 2019 (COVID-19) pandemic health restrictions which limited in-person visits. This analysis includes participants who completed the WMFT assessment prior to the study being conducted remotely.
The Wolf Motor Function Test (WMFT) assesses upper extremity motor ability with 17 functional tasks (15 timed and 2 strength tasks). The time, in seconds, required to complete each of 15 timed scores is calculated, with lower times (faster speeds) indicating higher functioning levels. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=5 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=2 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) Test Time Among Stroke Survivors
Baseline
|
4.2 seconds
Standard Deviation 3.9
|
27.9 seconds
Standard Deviation 34.4
|
|
Wolf Motor Function Test (WMFT) Test Time Among Stroke Survivors
2 Months Post-intervention
|
2.8 seconds
Standard Deviation 0.3
|
2.7 seconds
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: Baseline, 2 months post-interventionPopulation: This analysis includes participants who completed both the Baseline and 2 Months Post-intervention assessment. One dyad in the CARE-CITE study arm withdrew from the study after completing some of the questionnaires of the 2 Months-Post intervention evaluation but did not complete the remote assessment in which the MAL was administered.
The Motor Activity Log is 30-item questionnaire assessing use of the affected arm during normal daily activities. Responses are given on a Likert scale where 0 = the weaker arm was not used at all for that activity (never) to 5 = the ability to use the weaker arm for that activity was as good as before the stroke (normal). 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. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=16 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Quality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke Survivors
Baseline
|
2.4 score on a scale
Standard Deviation 1.3
|
2.2 score on a scale
Standard Deviation 1.1
|
|
Quality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke Survivors
2 Months Post-intervention
|
3.4 score on a scale
Standard Deviation 1.0
|
3.3 score on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Baseline, 2 months post-interventionQuality of life among stroke survivors was assessed with 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 social 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. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Strength Domain Score - Baseline
|
50.4 score on a scale
Standard Deviation 21.7
|
56.3 score on a scale
Standard Deviation 10.5
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Strength Domain Score - 2 Months Post-Intervention
|
64.2 score on a scale
Standard Deviation 19.5
|
58.3 score on a scale
Standard Deviation 10.9
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Memory and Thinking Domain Score - Baseline
|
76.3 score on a scale
Standard Deviation 28.5
|
73.8 score on a scale
Standard Deviation 16.1
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Memory and Thinking Domain Score - 2 Months Post-Intervention
|
91.7 score on a scale
Standard Deviation 12.0
|
82.7 score on a scale
Standard Deviation 22.2
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Emotions and Mood Domain Score - Baseline
|
60.0 score on a scale
Standard Deviation 10.7
|
61.5 score on a scale
Standard Deviation 10.4
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Emotions and Mood Domain Score - 2 Months Post-Intervention
|
60.3 score on a scale
Standard Deviation 14.0
|
55.2 score on a scale
Standard Deviation 15.4
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Communication Domain Score - Baseline
|
84.9 score on a scale
Standard Deviation 27.7
|
76.8 score on a scale
Standard Deviation 23.2
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Communication Domain Score - 2 Months Post-Intervention
|
88.8 score on a scale
Standard Deviation 18.4
|
78.0 score on a scale
Standard Deviation 22.5
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Activities of Daily Living Domain Score - Baseline
|
50.7 score on a scale
Standard Deviation 15.3
|
46.7 score on a scale
Standard Deviation 14.4
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Activities of Daily Living Domain Score - 2 Months Post-Intervention
|
59.5 score on a scale
Standard Deviation 15.7
|
63.7 score on a scale
Standard Deviation 10.6
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Mobility Domain Score - Baseline
|
45.9 score on a scale
Standard Deviation 23.0
|
57.0 score on a scale
Standard Deviation 12.3
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Mobility Domain Score - 2 Months Post-Intervention
|
55.3 score on a scale
Standard Deviation 15.3
|
62.2 score on a scale
Standard Deviation 16.8
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Function of Affected Upper Extremity Domain Score - Baseline
|
37.4 score on a scale
Standard Deviation 22.0
|
25.3 score on a scale
Standard Deviation 15.7
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Function of Affected Upper Extremity Domain Score - 2 Months Post-Intervention
|
46.7 score on a scale
Standard Deviation 22.0
|
51.3 score on a scale
Standard Deviation 27.1
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Social Participation Domain Score - Baseline
|
34.3 score on a scale
Standard Deviation 21.1
|
33.3 score on a scale
Standard Deviation 26.7
|
|
Stroke Impact Scale (SIS) Score Among Stroke Survivors
Social Participation Domain Score - 2 Months Post-Intervention
|
50.0 score on a scale
Standard Deviation 18.6
|
32.1 score on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Baseline, 2 months post-interventionThe Family Care Climate Questionnaire (FCCQ) for carepartners is 14-item questionnaire asking about the carepartners' experiences with the strokes survivor in relation to their rehabilitation activities. Each item is rated on a 7-point Likert scale ranging from 1 (not true at all) to 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. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score
Baseline
|
6.3 score on a scale
Standard Deviation 0.6
|
6.4 score on a scale
Standard Deviation 0.4
|
|
Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score
2 Months Post-intervention
|
6.4 score on a scale
Standard Deviation 0.3
|
6.6 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, 2 months post-interventionThe Family Care Climate Questionnaire (FCCQ) for stroke survivors is 14-item questionnaire asking about experiences with family members in relation to rehabilitation activities. Each item is rated on a 7-point Likert scale ranging from 1 (not true at all) to 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. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score
Baseline
|
6.6 score on a scale
Standard Deviation 0.4
|
6.5 score on a scale
Standard Deviation 0.4
|
|
Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score
2 Months Post-intervention
|
6.7 score on a scale
Standard Deviation 0.4
|
6.3 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, 2 months post-interventionFamily conflict was assessed among carepartners with the FCCS. The FCCS is a unidimensional, Likert scale composed of 15 items. For each item, participants indicate their agreement with the item as 1 = not true at all, to 7 = very true. Item scores are summed and total scores range from 15 to 105, where higher scores represent higher levels of conflict within a family. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Family Caregiver Conflict Scale (FCCS) Score Among Carepartners
Baseline
|
21.6 score on a scale
Standard Deviation 10.2
|
19.3 score on a scale
Standard Deviation 9.7
|
|
Family Caregiver Conflict Scale (FCCS) Score Among Carepartners
2 Months Post-intervention
|
20.9 score on a scale
Standard Deviation 8.5
|
20.2 score on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline, 2 months post-interventionStroke survivor upper extremity self efficacy was assessed with the Confidence in Hand and Movement (CAHM) scale. The CAHM is 20-item instrument where 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. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Confidence in Hand and Movement Scale (CAHM) Score
Baseline
|
48.8 score on a scale
Standard Deviation 29.2
|
50.5 score on a scale
Standard Deviation 28.2
|
|
Confidence in Hand and Movement Scale (CAHM) Score
2 Months Post-intervention
|
67.1 score on a scale
Standard Deviation 24.0
|
59.5 score on a scale
Standard Deviation 29.9
|
SECONDARY outcome
Timeframe: BaselineThe 12-item General Family Functioning scale from the McMaster Family Assessment Device measures general family functioning. Items are scored on a 4-point scale where 1 = healthy functioning and 4 = unhealthy functioning. A total score is obtained by summing the scores and calculating the average. Higher scores indicate ineffective family functioning. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Family Assessment Device (FAD) Scale Score Among Carepartners
|
1.77 score on a scale
Standard Deviation 0.37
|
1.78 score on a scale
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline, 2 months post-interventionThe CSI is a 13-question tool that measures strain related to care provision. Questions are responded to as either "Yes" or "No" and the total score is determined by summing the "Yes" responses. Total scores range from 0 to 13 and scores of 7 or more indicate high levels of stress. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Caregiver Strain Index (CSI) Score
Baseline
|
4.8 score on a scale
Standard Deviation 3.3
|
3.7 score on a scale
Standard Deviation 3.3
|
|
Caregiver Strain Index (CSI) Score
2 Months Post-intervention
|
4.5 score on a scale
Standard Deviation 3.9
|
4.0 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline, 2 months post-interventionThe BCOS is a unidimensional scale based on 15 items and addresses changes in caregiving social functioning, subjective well-being and physical health. Carepartners respond to statements on a 7-point Likert scale where 1 = changed for the worst, and 7 = changed for the best. Total scores range from 15 - 105 with higher scores representing more positive caregiving outcomes since the stroke. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Bakas Caregiving Outcomes Scale (BCOS) Score
Baseline
|
57.8 score on a scale
Standard Deviation 13.6
|
53.5 score on a scale
Standard Deviation 5.8
|
|
Bakas Caregiving Outcomes Scale (BCOS) Score
2 Months Post-intervention
|
59.9 score on a scale
Standard Deviation 8.6
|
55.7 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline, 2 months post-interventionPopulation: This analysis includes participants who completed both the Baseline and 2 Months Post-intervention assessment. One dyad in the CARE-CITE study arm withdrew from the study after completing some of the questionnaires of the 2 Months Post-intervention evaluation but did not complete the remote assessment in which the FMA was administered.
Upper extremity impairment was assessed by the Fugl-Meyer Assessment (FMA). The FMA evaluates and measures recovery in post-stroke hemiplegic patients with 5 domains: motor score (which is further separated for upper and lower extremity), sensation, balance, joint range of motion, and joint pain. Items are scored on a 3-point ordinal scale where 0 = cannot perform and 3 = performs fully. The total score for the upper extremity motor domain ranges from 0 to 66 and a higher score indicates greater arm function. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=16 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Fugl-Meyer Assessment (FMA) Upper Extremity Motor Score
Baseline
|
46.8 score on a scale
Standard Deviation 12.2
|
49.0 score on a scale
Standard Deviation 10.0
|
|
Fugl-Meyer Assessment (FMA) Upper Extremity Motor Score
2 Months Post-intervention
|
50.7 score on a scale
Standard Deviation 8.4
|
55.3 score on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline, 2 months post-interventionStroke survivor quality of life and social participation was assessed by the Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities. This is an 8- item, Likert-type scale about satisfaction in the last 7 days. Neuro-QoL scores are presented as T-scores with a mean of 50 and standard deviation of 10. Scores below 50 indicate below average satisfaction with social roles and activities. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Neuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke Survivors
Baseline
|
44.2 score on a scale
Standard Deviation 3.4
|
43.2 score on a scale
Standard Deviation 4.8
|
|
Neuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke Survivors
2 Months Post-intervention
|
45.6 score on a scale
Standard Deviation 4.8
|
45.0 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline, 2 months post-interventionDepressive symptoms among caregivers was assessed with the 6-item PROMIS Depression - Short Form 6a instrument. Responses are given on a scale from 1 to 5 where 1 = never and 5 = always. Total scores range from 6 to 30 where higher scores indicate greater feelings of depression. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a Score
Baseline
|
9.1 score on a scale
Standard Deviation 3.9
|
9.5 score on a scale
Standard Deviation 2.9
|
|
Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a Score
2 Months Post-intervention
|
8.6 score on a scale
Standard Deviation 3.8
|
9.0 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline, 2 months post-interventionFine motor skills and activities of daily living (ADL) related to upper extremity function was assessed by Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL). This is an 8-item, Likert-type scale assessing the respondent's ability to perform various manual activities of daily life. Responses are given on a 5-point scale where 1 = not at all and 5 = very much. The Neuro-QoL scores are standardized as T-scores with a mean of 50 and standard deviation of 10. Scores below 50 indicate below average upper extremity function. Unadjusted means are presented here.
Outcome measures
| Measure |
CARE-CITE Carepartner
n=17 Participants
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 Participants
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|
|
Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) Score
Baseline
|
29.6 score on a scale
Standard Deviation 6.7
|
32.8 score on a scale
Standard Deviation 13.6
|
|
Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) Score
2 Months Post-intervention
|
35.4 score on a scale
Standard Deviation 7.7
|
33.6 score on a scale
Standard Deviation 11.7
|
Adverse Events
CARE-CITE Carepartner
Control Carepartners
CARE-CITE Stroke Survivor
Control Stroke Survivors
Serious adverse events
| Measure |
CARE-CITE Carepartner
n=17 participants at risk
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 participants at risk
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
CARE-CITE Stroke Survivor
n=17 participants at risk
Stroke survivors of carepartners receiving the CARE-CITE intervention
|
Control Stroke Survivors
n=6 participants at risk
Stroke survivors receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall requiring hospitalization (unrelated to study intervention)
|
0.00%
0/17 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
0.00%
0/6 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
5.9%
1/17 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
0.00%
0/6 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
|
Vascular disorders
Stroke (unrelated to study intervention)
|
0.00%
0/17 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
0.00%
0/6 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
5.9%
1/17 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
0.00%
0/6 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
Other adverse events
| Measure |
CARE-CITE Carepartner
n=17 participants at risk
Carepartners receiving the CARE-CITE intervention
|
Control Carepartners
n=6 participants at risk
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
CARE-CITE Stroke Survivor
n=17 participants at risk
Stroke survivors of carepartners receiving the CARE-CITE intervention
|
Control Stroke Survivors
n=6 participants at risk
Stroke survivors receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
|
|---|---|---|---|---|
|
General disorders
Fall without injury (unrelated to study intervention)
|
0.00%
0/17 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
0.00%
0/6 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
11.8%
2/17 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
0.00%
0/6 • Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place