Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke

Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke

Sponsors

Lead sponsor: Emory University

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
American Heart Association

Source Emory University
Brief Summary

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.

Detailed 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.

Overall Status Completed
Start Date January 2016
Completion Date January 18, 2019
Primary Completion Date January 18, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Wolf Motor Function Test (WMFT) Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Motor Activity Log (MAL) Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Family Caregiver Conflict Scale (FCCS) Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Center for Epidemiologic Studies Depression Scale (CES-D) Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary Outcome
Measure Time Frame
Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Fugl-Meyer Assessment (FMA) Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Confidence in Arm and Hand (CAHM) Scale Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Stroke Impact Scale (SIS) Score Baseline, 1 Month Post-treatment (up to Week 7)
Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Piper Fatigue Scale (PFS) Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Caregiver Strain Index (CSI) Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Bakas Caregiving Outcomes Scale (BCOS) Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Caregiving Self Efficacy (Obtaining Respite Scale) Score Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Post Study System Usability Questionnaire (PSSUQ) Score Post-treatment (up to Week 3)
Enrollment 64
Condition
Intervention

Intervention type: Behavioral

Intervention name: CARE-CITE Education Program

Description: CARE-CITE is an online educational program developed to provide information that may help caregivers understand more about constraint-induced movement therapy (CIMT) and their potential roles in helping the stoke survivor gain as much benefit as possible from CIMT. If participants do not have access to a computer or tablet, they will be loaned an electronic tablet for the 2-3 week period of the study to access the information. Participants will be asked to review six educational modules over a period of 2-3 weeks while the stroke survivor receives CIMT. Participants will attend three in home evaluation visits; one at the beginning of the stroke survivors therapy sessions, one at the end of his/her therapy visit series, and a third evaluation one month later in which they will be asked to complete questionnaires. Evaluation visits will take approximately 1 ½ hours to complete.

Arm group label: CARE-CITE Education Program Carepartners

Intervention type: Behavioral

Intervention name: Traditional Education

Description: Investigators will explain constraint-induced movement therapy (CIMT) to caregivers and stroke survivors during the first home therapy session for the stroke survivor and provide traditional educational information about CIMT during therapy sessions as needed.

Arm group label: Traditional Education Carepartners

Intervention type: Behavioral

Intervention name: Constraint-Induced Movement Therapy (CIMT)

Description: Constraint-Induced Movement Therapy (CIMT) is one type of therapy that helps stroke survivors gain more use of their weaker arm.This therapy involves wearing a soft mitt (like a sock or oven mitt) on the stronger arm to remind the stroke survivor to use their weaker arm for daily activities and also intensive practice of tasks with the supervision of a therapist. Participants will attend three in home evaluation visits; one at the beginning of your therapy sessions, one at the end of your therapy visit series and a third evaluation one month later. These evaluation sessions will involve an evaluation of arm function and answering three questionnaires about how well the weaker arm works and how the stroke has affected daily activities. The interview questions and assessment will take approximately 1 ½ hours to complete.

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sarah Blanton Principal Investigator Emory University
Location
facility Emory University Hospital
Location Countries

United States

Verification Date

January 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Emory University

Investigator full name: Sarah Blanton

Investigator title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: Stroke Survivors with CARE-CITE Carepartners

Arm group type: Experimental

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.

Arm group label: CARE-CITE Education Program Carepartners

Arm group type: Experimental

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.

Arm group label: Traditional Education Carepartners

Arm group type: Active Comparator

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

Arm group label: Stroke Survivors with Traditional Education Carepartners

Arm group type: Active Comparator

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.

Acronym CARE-CITE
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov