Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke (CARE-CITE)

Emory University

Status: Completed

Conditions: Stroke

Treatments: Behavioral: CARE-CITE; Behavioral: Standard of care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04040751

R21NR018015 (U.S. NIH Grant/Contract)

IRB00107906

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 4 patient groups

CARE-CITE Carepartner

Experimental group

Description:

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.

Treatment:

Behavioral: CARE-CITE

Control Carepartners

Active Comparator group

Description:

Carepartners in this study arm receive 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.

Treatment:

Behavioral: Standard of care

CARE-CITE Stroke Survivor

Experimental group

Description:

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.

Treatment:

Behavioral: CARE-CITE

Control Stroke Survivors

Active Comparator group

Description:

Stroke survivors in this study arm receive customary care outpatient rehabilitation therapy but no CARE-CITE intervention. Carepartners of the stroke survivors 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.

Treatment:

Behavioral: Standard of care