Clinical trial NCT02703532: Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke
Official title: Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Therapy
Rehabilitation
Caregiver
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: American Heart Association
First posted: 2016-03-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Wolf Motor Function Test (WMFT)
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Motor Activity Log (MAL) Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Family Caregiver Conflict Scale (FCCS) Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Center for Epidemiologic Studies Depression Scale (CES-D) Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Secondary outcomes:
measure: Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Fugl-Meyer Assessment (FMA) Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Confidence in Arm and Hand (CAHM) Scale Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Stroke Impact Scale (SIS) Score
timeFrame: Baseline, 1 Month Post-treatment (up to Week 7)
measure: Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Piper Fatigue Scale (PFS) Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Caregiver Strain Index (CSI) Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Bakas Caregiving Outcomes Scale (BCOS) Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Caregiving Self Efficacy (Obtaining Respite Scale) Score
timeFrame: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
measure: Post Study System Usability Questionnaire (PSSUQ) Score
timeFrame: Post-treatment (up to Week 3)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Sarah Blanton
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanton S, Clark PC, Lyles RH, Cotsonis G, Jones BD, Reiss A, Wolf SL, Dunbar S. A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2019 Apr 25;5:58. doi: 10.1186/s40814-019-0439-0. eCollection 2019.