N/A
N=46
Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04040751 ↗Enrolled (actual)
46
Serious AEs
4.4%
Results posted
Jan 2023
Primary outcome: Primary: Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners — 9.9; 11.2; 9.1; 9.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CARE-CITE (Behavioral); Standard of care (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners |
9.9; 11.2; 9.1; 9.3 | — |
| PRIMARY Short Form Health Survey (SF-36) Scale Score Among Carepartners |
73.9; 92.5; 82.3; 85.8; 70.6; 83.3 | — |
| PRIMARY Wolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS) |
59.0; 43.0; 59.5; 55.5 | — |
| PRIMARY Wolf Motor Function Test (WMFT) Test Time Among Stroke Survivors |
4.2; 27.9; 2.8; 2.7 | — |
| PRIMARY Quality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke Survivors |
2.4; 2.2; 3.4; 3.3 | — |
| PRIMARY Stroke Impact Scale (SIS) Score Among Stroke Survivors |
50.4; 56.3; 64.2; 58.3; 76.3; 73.8 | — |
| SECONDARY Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score |
6.3; 6.4; 6.4; 6.6 | — |
| SECONDARY Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score |
6.6; 6.5; 6.7; 6.3 | — |
| SECONDARY Family Caregiver Conflict Scale (FCCS) Score Among Carepartners |
21.6; 19.3; 20.9; 20.2 | — |
| SECONDARY Confidence in Hand and Movement Scale (CAHM) Score |
48.8; 50.5; 67.1; 59.5 | — |
| SECONDARY Family Assessment Device (FAD) Scale Score Among Carepartners |
1.77; 1.78 | — |
| SECONDARY Caregiver Strain Index (CSI) Score |
4.8; 3.7; 4.5; 4.0 | — |
| SECONDARY Bakas Caregiving Outcomes Scale (BCOS) Score |
57.8; 53.5; 59.9; 55.7 | — |
| SECONDARY Fugl-Meyer Assessment (FMA) Upper Extremity Motor Score |
46.8; 49.0; 50.7; 55.3 | — |
| SECONDARY Neuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke Survivors |
44.2; 43.2; 45.6; 45.0 | — |
| SECONDARY Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a Score |
9.1; 9.5; 8.6; 9.0 | — |
| SECONDARY Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) Score |
29.6; 32.8; 35.4; 33.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04040751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.