Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke

NCT ID: NCT04040751

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-09
• Study Completion Date: 2021-12-21

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

CARE-CITE

Intervention Type: BEHAVIORAL

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.

Control Carepartners

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.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: BEHAVIORAL

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).

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.

Group Type: EXPERIMENTAL

CARE-CITE

Intervention Type: BEHAVIORAL

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.

Control Stroke Survivors

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.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: BEHAVIORAL

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).

Interventions

CARE-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.

Intervention Type: BEHAVIORAL

Standard 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Sarah Blanton

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Blanton, PT, DPT

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21NR018015

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00107906

Identifier Type: -

Identifier Source: org_study_id