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

Recruiting

Phase 1 Results N/A

Trial 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. 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.

Conditions

Interventions

  • Constraint-induced movement therapy (CIMT) Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Stroke Survivors
    Description: Participants who have survived a stroke will receive constraint-induced movement therapy (CIMT) while their caregiver participates in an educational program. The caregiver of the stroke survivor may be randomized to receive CARE-CITE education or traditional education.
  • CARE-CITE Education Program Behavioral
    Intervention Desc: 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 1: Kind: Experimental
    Label: CARE-CITE Education Program Carepartners
    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.
  • Traditional Education Behavioral
    Intervention Desc: 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 1: Kind: Experimental
    Label: Traditional Education Carepartners
    Description: Caregivers (someone who assists in the care of stroke survivors) will participate in traditional education while their partner (stroke survivor) receives therapy.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Supportive Care
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Motor Ability and Impairments assessed by the Wolf Motor Function Test (WMFT) Baseline, Post Intervention (1 month) No
Primary Change in Upper Extremity Function and Use assessed by the Motor Activity Log (MAL) Baseline, Post Intervention (1 month) No
Primary Change in Family Conflict assessed by the Family Caregiver Conflict Scale (FCCS-F) Baseline, Post Intervention (1 month) No
Primary Change in Depression Status assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) Baseline, Post Intervention (1 month) No
Secondary Change in the Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCC-SS) Score Baseline, Post Intervention (1 month) No
Secondary Change in Upper Extremity Impairment assessed by the Fugl-Meyer Assessment (FMA) Baseline, Post Intervention (1 month) No
Secondary Change in Upper Extremity Self-Efficacy assessed by the Confidence in Arm and Hand (CAHM) Scale Baseline, Post Intervention (1 month) No
Secondary Change in Quality of Life assessed by the Stroke Impact Scale (SIS) Baseline, Post Intervention (1 month) No
Secondary Change in the Family Assessment Device (FAD) Scale Score Baseline, Post Intervention (1 month) No
Secondary Change in the Memory and Behavior Problems Checklist (MBPC) Score Baseline, Post Intervention (1 month) No
Secondary Change in the Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCC-CP) Scale Score Baseline, Post Intervention (1 month) No
Secondary Change in Fatigue Level assessed by the Piper Fatigue Scale (PFS) Baseline, Post Intervention (1 month) No
Secondary Change in Caregiver Strain assessed by the Caregiver Strain Index (CSI) Baseline, Post Intervention (1 month) No
Secondary Change in Bakas Caregiving Outcomes Scale (BCOS) Score Baseline, Post Intervention (1 month) No
Secondary Change in Caregiving Self Efficacy (Respite Scale) Score Baseline, Post Intervention (1 month) No
Secondary Change in Modified Computer Self Efficacy Scale (CSES) Score Baseline, Post Intervention (1 month) No
Secondary Change in Post Study System Usability Questionnaire (PSSUQ) Score Baseline, Post Intervention (1 month) No

Sponsors