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Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke

Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04040751
Acronym
CARE-CITE
Enrollment
46
Registered
2019-08-01
Start date
2019-08-09
Completion date
2021-12-21
Last updated
2023-01-19

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

Conditions

Stroke

Keywords

Telehealth, Rehabilitation, Care partner, Sub-acute stroke, CARE-CITE, Stroke survivors

Brief summary

Carepartner and Collaborative Integrated Therapy (CARE-CITE) is a novel, web-based carepartner focused intervention designed to foster problem solving and skill building while facilitating carepartner engagement during upper extremity functional activities in the home setting. The proposed study will evaluate the application of the CARE-CITE intervention paired with usual and customary care during the sub-acute stroke.

Detailed description

Stroke is a leading cause of serious, long-term disability in the United States, and has a particularly harmful impact on individuals and families. Approximately 4.8 million stroke survivors require assistance from family members who are often untrained and ill prepared for the burdens associated with stroke rehabilitation. Family carepartners are key contributors to stroke recovery, but their efforts can lead them to experience a high level of burden and depressive symptoms, reduced quality of life and increased stress in the context of high levels of family conflict surrounding the recovery process. Rehabilitation therapy interventions have primarily targeted stroke survivor outcomes without specifically addressing the well-being of the carepartner. The researchers of this study have developed a theory-based, family-centered intervention, Carepartner and Collaborative Integrated Therapy (CARE-CITE), designed to engage carepartners during stroke survivor upper extremity (UE) functional task practice in the home. Residual UE impairments occur in up to 80% of stroke survivors and are a primary factor in loss of functional independence. CARE-CITE guides the carepartner in collaborative goal setting and providing autonomy support (characterized by empathy, choice and reducing use of controlling language) for the stroke survivor to promote motivation and creative problem solving in UE self-management. Participating stroke survivor and carepartner dyads will be randomized to receive the CARE-CITE intervention with usual customary care, or usual customary care alone for four weeks.

Interventions

BEHAVIORALCARE-CITE

The primary CARE-CITE components will be education via web platform. Carepartners complete 6 online CARE-CITE modules (15-30-minute sessions each). The modules include demonstration videos and instructive content covering following areas: principles of functional task practice (i.e., activities of daily living such as eating, grooming, or leisure/vocational activities), adaptation of tasks, and importance of progression of challenging tasks to drive neuroplasticity (i.e., increasing numbers of practice repetitions or weight of objects lifted). Underpinning the content is the concept of autonomy support, with examples of fostering empathy, problem solving, instruction in the use of non-controlling language with role playing situations and the importance of creating choice in activities.

BEHAVIORALStandard of care

The carepartner will receive a support brochure with general caregiving information including website resources to mimic web interaction of intervention group (e.g., stroke caregiver resource site).

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for Stroke Survivors: * 1-3 months post ischemic or hemorrhagic event * discharged from inpatient neurologic rehabilitation to their home * have minimal to moderate upper extremity (UE) deficits (actively initiate 20 degrees of wrist and 10 degrees of finger extension) * no severe cognitive deficits (Mini -mental test \>24) * no physician determined major medical problems that would limit participation in outpatient therapy Inclusion Criteria for Carepartners: * spouse/partner or family member * dwelling in the same household * self-identify as the primary caregiver of the stroke survivor * \>21 years old * able to read and write English * have no significant cognitive deficits (Mini -mental test \>24) * familiar with using a computer and accessing websites, or with using a tablet

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among CarepartnersBaseline, 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.
Short Form Health Survey (SF-36) Scale Score Among CarepartnersBaseline, 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.
Wolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)Baseline, 2 months post-interventionThe 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.
Wolf Motor Function Test (WMFT) Test Time Among Stroke SurvivorsBaseline, 2 months post-interventionThe 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.
Quality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke SurvivorsBaseline, 2 months post-interventionThe 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.
Stroke Impact Scale (SIS) Score Among Stroke SurvivorsBaseline, 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.

Secondary

MeasureTime frameDescription
Bakas Caregiving Outcomes Scale (BCOS) ScoreBaseline, 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.
Fugl-Meyer Assessment (FMA) Upper Extremity Motor ScoreBaseline, 2 months post-interventionUpper 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.
Family Care Climate Questionnaire - Carepartners (FCCQ-CP) ScoreBaseline, 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.
Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a ScoreBaseline, 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.
Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) ScoreBaseline, 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.
Neuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke SurvivorsBaseline, 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.
Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) ScoreBaseline, 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.
Family Caregiver Conflict Scale (FCCS) Score Among CarepartnersBaseline, 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.
Confidence in Hand and Movement Scale (CAHM) ScoreBaseline, 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.
Family Assessment Device (FAD) Scale Score Among CarepartnersBaselineThe 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.
Caregiver Strain Index (CSI) ScoreBaseline, 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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
CARE-CITE Carepartner
Carepartners receiving the CARE-CITE intervention
17
Control Carepartners
Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
6
CARE-CITE Stroke Survivor
Stroke survivors of carepartners receiving the CARE-CITE intervention
17
Control Stroke Survivors
Stroke survivors receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention
6
Total46

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyWithdrawal by Subject2020

Baseline characteristics

CharacteristicControl CarepartnersTotalControl Stroke SurvivorsCARE-CITE Stroke SurvivorCARE-CITE Carepartner
Age, Continuous58.5 years
STANDARD_DEVIATION 12.2
58.1 years
STANDARD_DEVIATION 13.4
60.7 years
STANDARD_DEVIATION 13.4
60.6 years
STANDARD_DEVIATION 11.4
54.6 years
STANDARD_DEVIATION 12.6
Education
1-3 years of college
3 Participants13 Participants4 Participants3 Participants3 Participants
Education
4 or more years of college
3 Participants26 Participants2 Participants10 Participants11 Participants
Education
High school or less
0 Participants7 Participants0 Participants4 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants5 Participants0 Participants3 Participants2 Participants
Race (NIH/OMB)
Black or African American
0 Participants17 Participants1 Participants8 Participants8 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
5 Participants20 Participants4 Participants5 Participants6 Participants
Region of Enrollment
United States
6 Participants46 Participants6 Participants17 Participants17 Participants
Sex: Female, Male
Female
5 Participants29 Participants2 Participants9 Participants13 Participants
Sex: Female, Male
Male
1 Participants17 Participants4 Participants8 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 170 / 60 / 170 / 6
other
Total, other adverse events
0 / 170 / 62 / 170 / 6
serious
Total, serious adverse events
0 / 170 / 62 / 170 / 6

Outcome results

Primary

Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners

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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerCenter for Epidemiologic Studies - Depression (CES-D) Scale Score Among CarepartnersBaseline9.9 score on a scaleStandard Deviation 9.7
CARE-CITE CarepartnerCenter for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners2 Months Post-intervention9.1 score on a scaleStandard Deviation 8.2
Control CarepartnersCenter for Epidemiologic Studies - Depression (CES-D) Scale Score Among CarepartnersBaseline11.2 score on a scaleStandard Deviation 8.5
Control CarepartnersCenter for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners2 Months Post-intervention9.3 score on a scaleStandard Deviation 4.8
Primary

Quality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke Survivors

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.

Time frame: Baseline, 2 months post-intervention

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerQuality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke SurvivorsBaseline2.4 score on a scaleStandard Deviation 1.3
CARE-CITE CarepartnerQuality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke Survivors2 Months Post-intervention3.4 score on a scaleStandard Deviation 1
Control CarepartnersQuality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke SurvivorsBaseline2.2 score on a scaleStandard Deviation 1.1
Control CarepartnersQuality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke Survivors2 Months Post-intervention3.3 score on a scaleStandard Deviation 1.2
Primary

Short Form Health Survey (SF-36) Scale Score Among Carepartners

Carepartner 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersPhysical Functioning - Baseline73.9 score on a scaleStandard Deviation 21.6
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersPhysical Functioning - 2 Months Post-intervention82.3 score on a scaleStandard Deviation 13.1
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersRole Limitation, Physical - Baseline70.6 score on a scaleStandard Deviation 42.6
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersRole Limitation, Physical - 2 Months Post-intervention76.7 score on a scaleStandard Deviation 38.3
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersRole Limitation, Emotional - Baseline70.6 score on a scaleStandard Deviation 30.4
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersRole Limitation, Emotional - 2 Months Post-intervention82.2 score on a scaleStandard Deviation 18.3
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersEnergy/Vitality - Baseline58.2 score on a scaleStandard Deviation 21.1
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersEnergy/Vitality - 2 Months Post-intervention64.0 score on a scaleStandard Deviation 16.4
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersEmotional Well Being - Baseline74.6 score on a scaleStandard Deviation 18.9
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersEmotional Well Being - 2 Months Post-intervention76.3 score on a scaleStandard Deviation 16
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersSocial Functioning - Baseline76.5 score on a scaleStandard Deviation 22.5
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersSocial Functioning - 2 Months Post-intervention83.3 score on a scaleStandard Deviation 23.5
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersPain - Baseline81.0 score on a scaleStandard Deviation 16.8
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersPain - 2 Months Post-intervention77.2 score on a scaleStandard Deviation 22.6
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersGeneral Health - Baseline67.4 score on a scaleStandard Deviation 10.5
CARE-CITE CarepartnerShort Form Health Survey (SF-36) Scale Score Among CarepartnersGeneral Health - 2 Months Post-intervention71.0 score on a scaleStandard Deviation 9.7
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersGeneral Health - 2 Months Post-intervention76.7 score on a scaleStandard Deviation 5.2
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersPhysical Functioning - Baseline92.5 score on a scaleStandard Deviation 8.2
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersEmotional Well Being - Baseline74.0 score on a scaleStandard Deviation 12.3
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersPhysical Functioning - 2 Months Post-intervention85.8 score on a scaleStandard Deviation 15.6
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersPain - Baseline78.8 score on a scaleStandard Deviation 13.9
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersRole Limitation, Physical - Baseline83.3 score on a scaleStandard Deviation 20.4
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersEmotional Well Being - 2 Months Post-intervention81.3 score on a scaleStandard Deviation 12.8
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersRole Limitation, Physical - 2 Months Post-intervention70.8 score on a scaleStandard Deviation 45.9
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersGeneral Health - Baseline72.5 score on a scaleStandard Deviation 7.6
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersRole Limitation, Emotional - Baseline91.7 score on a scaleStandard Deviation 13.9
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersSocial Functioning - Baseline83.3 score on a scaleStandard Deviation 30.3
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersRole Limitation, Emotional - 2 Months Post-intervention83.3 score on a scaleStandard Deviation 14.9
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersPain - 2 Months Post-intervention73.8 score on a scaleStandard Deviation 31.7
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersEnergy/Vitality - Baseline47.5 score on a scaleStandard Deviation 27.2
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersSocial Functioning - 2 Months Post-intervention83.3 score on a scaleStandard Deviation 21.9
Control CarepartnersShort Form Health Survey (SF-36) Scale Score Among CarepartnersEnergy/Vitality - 2 Months Post-intervention55.0 score on a scaleStandard Deviation 28.1
Primary

Stroke Impact Scale (SIS) Score Among Stroke Survivors

Quality 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsActivities of Daily Living Domain Score - Baseline50.7 score on a scaleStandard Deviation 15.3
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsCommunication Domain Score - Baseline84.9 score on a scaleStandard Deviation 27.7
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsActivities of Daily Living Domain Score - 2 Months Post-Intervention59.5 score on a scaleStandard Deviation 15.7
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsEmotions and Mood Domain Score - Baseline60.0 score on a scaleStandard Deviation 10.7
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsMobility Domain Score - Baseline45.9 score on a scaleStandard Deviation 23
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsStrength Domain Score - 2 Months Post-Intervention64.2 score on a scaleStandard Deviation 19.5
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsMobility Domain Score - 2 Months Post-Intervention55.3 score on a scaleStandard Deviation 15.3
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsEmotions and Mood Domain Score - 2 Months Post-Intervention60.3 score on a scaleStandard Deviation 14
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsFunction of Affected Upper Extremity Domain Score - Baseline37.4 score on a scaleStandard Deviation 22
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsStrength Domain Score - Baseline50.4 score on a scaleStandard Deviation 21.7
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsFunction of Affected Upper Extremity Domain Score - 2 Months Post-Intervention46.7 score on a scaleStandard Deviation 22
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsMemory and Thinking Domain Score - Baseline76.3 score on a scaleStandard Deviation 28.5
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsSocial Participation Domain Score - Baseline34.3 score on a scaleStandard Deviation 21.1
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsCommunication Domain Score - 2 Months Post-Intervention88.8 score on a scaleStandard Deviation 18.4
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsSocial Participation Domain Score - 2 Months Post-Intervention50.0 score on a scaleStandard Deviation 18.6
CARE-CITE CarepartnerStroke Impact Scale (SIS) Score Among Stroke SurvivorsMemory and Thinking Domain Score - 2 Months Post-Intervention91.7 score on a scaleStandard Deviation 12
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsSocial Participation Domain Score - 2 Months Post-Intervention32.1 score on a scaleStandard Deviation 9.7
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsStrength Domain Score - Baseline56.3 score on a scaleStandard Deviation 10.5
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsStrength Domain Score - 2 Months Post-Intervention58.3 score on a scaleStandard Deviation 10.9
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsMemory and Thinking Domain Score - 2 Months Post-Intervention82.7 score on a scaleStandard Deviation 22.2
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsEmotions and Mood Domain Score - Baseline61.5 score on a scaleStandard Deviation 10.4
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsEmotions and Mood Domain Score - 2 Months Post-Intervention55.2 score on a scaleStandard Deviation 15.4
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsCommunication Domain Score - Baseline76.8 score on a scaleStandard Deviation 23.2
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsCommunication Domain Score - 2 Months Post-Intervention78.0 score on a scaleStandard Deviation 22.5
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsActivities of Daily Living Domain Score - Baseline46.7 score on a scaleStandard Deviation 14.4
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsActivities of Daily Living Domain Score - 2 Months Post-Intervention63.7 score on a scaleStandard Deviation 10.6
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsMobility Domain Score - Baseline57.0 score on a scaleStandard Deviation 12.3
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsMobility Domain Score - 2 Months Post-Intervention62.2 score on a scaleStandard Deviation 16.8
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsFunction of Affected Upper Extremity Domain Score - Baseline25.3 score on a scaleStandard Deviation 15.7
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsFunction of Affected Upper Extremity Domain Score - 2 Months Post-Intervention51.3 score on a scaleStandard Deviation 27.1
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsSocial Participation Domain Score - Baseline33.3 score on a scaleStandard Deviation 26.7
Control CarepartnersStroke Impact Scale (SIS) Score Among Stroke SurvivorsMemory and Thinking Domain Score - Baseline73.8 score on a scaleStandard Deviation 16.1
Primary

Wolf Motor Function Test (WMFT) Test Time Among Stroke Survivors

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.

Time frame: Baseline, 2 months post-intervention

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerWolf Motor Function Test (WMFT) Test Time Among Stroke SurvivorsBaseline4.2 secondsStandard Deviation 3.9
CARE-CITE CarepartnerWolf Motor Function Test (WMFT) Test Time Among Stroke Survivors2 Months Post-intervention2.8 secondsStandard Deviation 0.3
Control CarepartnersWolf Motor Function Test (WMFT) Test Time Among Stroke SurvivorsBaseline27.9 secondsStandard Deviation 34.4
Control CarepartnersWolf Motor Function Test (WMFT) Test Time Among Stroke Survivors2 Months Post-intervention2.7 secondsStandard Deviation 0.8
Primary

Wolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)

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.

Time frame: Baseline, 2 months post-intervention

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerWolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)Baseline59.0 score on a scaleStandard Deviation 3.9
CARE-CITE CarepartnerWolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)2 Months Post-intervention59.5 score on a scaleStandard Deviation 7.8
Control CarepartnersWolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)Baseline43.0 score on a scaleStandard Deviation 5.7
Control CarepartnersWolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)2 Months Post-intervention55.5 score on a scaleStandard Deviation 0.7
Secondary

Bakas Caregiving Outcomes Scale (BCOS) Score

The 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerBakas Caregiving Outcomes Scale (BCOS) ScoreBaseline57.8 score on a scaleStandard Deviation 13.6
CARE-CITE CarepartnerBakas Caregiving Outcomes Scale (BCOS) Score2 Months Post-intervention59.9 score on a scaleStandard Deviation 8.6
Control CarepartnersBakas Caregiving Outcomes Scale (BCOS) ScoreBaseline53.5 score on a scaleStandard Deviation 5.8
Control CarepartnersBakas Caregiving Outcomes Scale (BCOS) Score2 Months Post-intervention55.7 score on a scaleStandard Deviation 4.3
Secondary

Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a Score

Depressive 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerCaregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a ScoreBaseline9.1 score on a scaleStandard Deviation 3.9
CARE-CITE CarepartnerCaregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a Score2 Months Post-intervention8.6 score on a scaleStandard Deviation 3.8
Control CarepartnersCaregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a ScoreBaseline9.5 score on a scaleStandard Deviation 2.9
Control CarepartnersCaregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a Score2 Months Post-intervention9.0 score on a scaleStandard Deviation 2.3
Secondary

Caregiver Strain Index (CSI) Score

The 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerCaregiver Strain Index (CSI) ScoreBaseline4.8 score on a scaleStandard Deviation 3.3
CARE-CITE CarepartnerCaregiver Strain Index (CSI) Score2 Months Post-intervention4.5 score on a scaleStandard Deviation 3.9
Control CarepartnersCaregiver Strain Index (CSI) ScoreBaseline3.7 score on a scaleStandard Deviation 3.3
Control CarepartnersCaregiver Strain Index (CSI) Score2 Months Post-intervention4.0 score on a scaleStandard Deviation 3.4
Secondary

Confidence in Hand and Movement Scale (CAHM) Score

Stroke 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerConfidence in Hand and Movement Scale (CAHM) ScoreBaseline48.8 score on a scaleStandard Deviation 29.2
CARE-CITE CarepartnerConfidence in Hand and Movement Scale (CAHM) Score2 Months Post-intervention67.1 score on a scaleStandard Deviation 24
Control CarepartnersConfidence in Hand and Movement Scale (CAHM) ScoreBaseline50.5 score on a scaleStandard Deviation 28.2
Control CarepartnersConfidence in Hand and Movement Scale (CAHM) Score2 Months Post-intervention59.5 score on a scaleStandard Deviation 29.9
Secondary

Family Assessment Device (FAD) Scale Score Among Carepartners

The 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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
CARE-CITE CarepartnerFamily Assessment Device (FAD) Scale Score Among Carepartners1.77 score on a scaleStandard Deviation 0.37
Control CarepartnersFamily Assessment Device (FAD) Scale Score Among Carepartners1.78 score on a scaleStandard Deviation 0.33
Secondary

Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score

The 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerFamily Care Climate Questionnaire - Carepartners (FCCQ-CP) ScoreBaseline6.3 score on a scaleStandard Deviation 0.6
CARE-CITE CarepartnerFamily Care Climate Questionnaire - Carepartners (FCCQ-CP) Score2 Months Post-intervention6.4 score on a scaleStandard Deviation 0.3
Control CarepartnersFamily Care Climate Questionnaire - Carepartners (FCCQ-CP) ScoreBaseline6.4 score on a scaleStandard Deviation 0.4
Control CarepartnersFamily Care Climate Questionnaire - Carepartners (FCCQ-CP) Score2 Months Post-intervention6.6 score on a scaleStandard Deviation 0.6
Secondary

Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score

The 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerFamily Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) ScoreBaseline6.6 score on a scaleStandard Deviation 0.4
CARE-CITE CarepartnerFamily Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score2 Months Post-intervention6.7 score on a scaleStandard Deviation 0.4
Control CarepartnersFamily Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) ScoreBaseline6.5 score on a scaleStandard Deviation 0.4
Control CarepartnersFamily Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score2 Months Post-intervention6.3 score on a scaleStandard Deviation 1
Secondary

Family Caregiver Conflict Scale (FCCS) Score Among Carepartners

Family 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerFamily Caregiver Conflict Scale (FCCS) Score Among CarepartnersBaseline21.6 score on a scaleStandard Deviation 10.2
CARE-CITE CarepartnerFamily Caregiver Conflict Scale (FCCS) Score Among Carepartners2 Months Post-intervention20.9 score on a scaleStandard Deviation 8.5
Control CarepartnersFamily Caregiver Conflict Scale (FCCS) Score Among CarepartnersBaseline19.3 score on a scaleStandard Deviation 9.7
Control CarepartnersFamily Caregiver Conflict Scale (FCCS) Score Among Carepartners2 Months Post-intervention20.2 score on a scaleStandard Deviation 6
Secondary

Fugl-Meyer Assessment (FMA) Upper Extremity Motor Score

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.

Time frame: Baseline, 2 months post-intervention

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerFugl-Meyer Assessment (FMA) Upper Extremity Motor ScoreBaseline46.8 score on a scaleStandard Deviation 12.2
CARE-CITE CarepartnerFugl-Meyer Assessment (FMA) Upper Extremity Motor Score2 Months Post-intervention50.7 score on a scaleStandard Deviation 8.4
Control CarepartnersFugl-Meyer Assessment (FMA) Upper Extremity Motor ScoreBaseline49.0 score on a scaleStandard Deviation 10
Control CarepartnersFugl-Meyer Assessment (FMA) Upper Extremity Motor Score2 Months Post-intervention55.3 score on a scaleStandard Deviation 6
Secondary

Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) Score

Fine 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerNeuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) ScoreBaseline29.6 score on a scaleStandard Deviation 6.7
CARE-CITE CarepartnerNeuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) Score2 Months Post-intervention35.4 score on a scaleStandard Deviation 7.7
Control CarepartnersNeuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) ScoreBaseline32.8 score on a scaleStandard Deviation 13.6
Control CarepartnersNeuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) Score2 Months Post-intervention33.6 score on a scaleStandard Deviation 11.7
Secondary

Neuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke Survivors

Stroke 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.

Time frame: Baseline, 2 months post-intervention

ArmMeasureGroupValue (MEAN)Dispersion
CARE-CITE CarepartnerNeuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke SurvivorsBaseline44.2 score on a scaleStandard Deviation 3.4
CARE-CITE CarepartnerNeuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke Survivors2 Months Post-intervention45.6 score on a scaleStandard Deviation 4.8
Control CarepartnersNeuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke Survivors2 Months Post-intervention45.0 score on a scaleStandard Deviation 7.7
Control CarepartnersNeuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke SurvivorsBaseline43.2 score on a scaleStandard Deviation 4.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026