Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke (CARE-CITE)

Emory University

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Constraint-Induced Movement Therapy (CIMT); Behavioral: Traditional Education; Behavioral: CARE-CITE Education Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02703532

IRB00070957

K23HD080837 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. By learning the best way to involve family members in therapy, investigators hope to decrease the harmful effects of stroke.

Full description

The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. A tablet will be provided to participants who do not have access to complete the web based intervention. All participants will be asked to complete questionnaires at the beginning of therapy, the end of therapy, and one month post therapy.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Stroke Survivors

• One month to five years post ischemic or hemorrhagic event
• Minimal to moderate upper extremity deficits (ability to initiate wrist and finger extension)
• Mini-mental screening test score of greater than 24
• Presence of a care partner

Caregivers

• At least 18 years old
• Ability to read and write English
• Mini-mental screening test score of greater than 24

Exclusion criteria

Stroke Survivors

• Severe cognitive deficits

Caregivers

• Significant cognitive deficits

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 4 patient groups

Stroke Survivors with CARE-CITE Carepartners

Experimental group

Description:

Stroke survivors with a carepartner randomized to the CARE-CITE intervention. Participants who have survived a stroke will receive constraint-induced movement therapy (CIMT) while their caregiver participates in an educational program.

Treatment:

Behavioral: Constraint-Induced Movement Therapy (CIMT)

CARE-CITE Education Program Carepartners

Experimental group

Description:

Caregivers (someone who assists in the care of stroke survivors) will participate in online CARE-CITE education while their partner (stroke survivor) receives therapy.

Treatment:

Behavioral: CARE-CITE Education Program

Traditional Education Carepartners

Active Comparator group

Description:

Caregivers (someone who assists in the care of stroke survivors) will participate in traditional education while their partner (stroke survivor) receives therapy.

Treatment:

Behavioral: Traditional Education

Stroke Survivors with Traditional Education Carepartners

Active Comparator group

Description:

Stroke survivors with a carepartner randomized to receive traditional education. Participants who have survived a stroke will receive constraint-induced movement therapy (CIMT) while their caregiver participates in an educational program.

Treatment:

Behavioral: Constraint-Induced Movement Therapy (CIMT)