Clinical trial NCT04040751: Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke
Official title: Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Telehealth
Rehabilitation
Care partner
Sub-acute stroke
CARE-CITE
Stroke survivors
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-08-01
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners
timeFrame: Baseline, 2 months post-intervention
measure: Short Form Health Survey (SF-36) Scale Score Among Carepartners
timeFrame: Baseline, 2 months post-intervention
measure: Wolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)
timeFrame: Baseline, 2 months post-intervention
measure: Wolf Motor Function Test (WMFT) Test Time Among Stroke Survivors
timeFrame: Baseline, 2 months post-intervention
measure: Quality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke Survivors
timeFrame: Baseline, 2 months post-intervention
measure: Stroke Impact Scale (SIS) Score Among Stroke Survivors
timeFrame: Baseline, 2 months post-intervention
Secondary outcomes:
measure: Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score
timeFrame: Baseline, 2 months post-intervention
measure: Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score
timeFrame: Baseline, 2 months post-intervention
measure: Family Caregiver Conflict Scale (FCCS) Score Among Carepartners
timeFrame: Baseline, 2 months post-intervention
measure: Confidence in Hand and Movement Scale (CAHM) Score
timeFrame: Baseline, 2 months post-intervention
measure: Family Assessment Device (FAD) Scale Score Among Carepartners
timeFrame: Baseline
measure: Caregiver Strain Index (CSI) Score
timeFrame: Baseline, 2 months post-intervention
measure: Bakas Caregiving Outcomes Scale (BCOS) Score
timeFrame: Baseline, 2 months post-intervention
measure: Fugl-Meyer Assessment (FMA) Upper Extremity Motor Score
timeFrame: Baseline, 2 months post-intervention
measure: Neuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke Survivors
timeFrame: Baseline, 2 months post-intervention
measure: Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a Score
timeFrame: Baseline, 2 months post-intervention
measure: Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) Score
timeFrame: Baseline, 2 months post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Sarah Blanton, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: