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

NCT02703532 | Completed Results DMC

• 2 other identifiers: IRB00070957K23HD080837
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Therapy; Rehabilitation; Caregiver

Outcome Measures

Primary Outcomes (4)

• Wolf Motor Function Test (WMFT)

  Motor ability and impairments will be assessed using the Wolf Motor Function Test (WMFT) an assessment tool used to evaluate upper extremity performance while providing insight into joint-specific and total limb movements. Values represent the amount of time, in seconds, to complete the assessment. Lower scores (faster speed) are indicative of higher functioning levels.

  Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)

• Motor Activity Log (MAL) Score

  Upper extremity function and use will be assessed using the Motor Activity Log (MAL). The MAL is a semi-structured interview to assess arm function. Participants are asked to rate quality of movement (QOM) during 28 daily functional tasks. Items are scored on a 6-point ordinal scale, from 0 to 5, where 0 = the affected arm was of no use and 5 = affected arm is functioning normally. The total score is the average of all items and ranges from 0 to 5, where higher values indicate greater function of the arm that was impacted by the stroke.

  Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)

• Family Caregiver Conflict Scale (FCCS) Score

  Family conflict will be assessed using the Family Caregiver Conflict Scale (FCCS). The FCCS is 15-item scale that measures family conflict between caregivers and other family by assessing disagreements over caring for the care recipient with items such as: "We have disagreements when I ask family members to help me take care of our relative." Items are scored from 1 to 7 where 1 = not true at all and 7 = very true. total scores range from 15 to 105 and higher scores indicate greater family conflict.

  Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)

• Center for Epidemiologic Studies Depression Scale (CES-D) Score

  Depressive symptoms among carepartners will be assessed by the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a screening test for depression and depressive disorder. The CES-D measures the frequency and severity of 20 depressive symptoms experienced during the last week. Each item is scored from 0 to 3 where 0 = rarely and 3 = most days and certain items are reverse scored so that greater symptomatology is assigned a higher score. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression. Scores of 16 or greater are considered as an indicator of potential clinical depression.

  Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)

Secondary Outcomes (11)

• 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)

Study Arms (4)

Stroke Survivors with CARE-CITE Carepartners

EXPERIMENTAL

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.

Behavioral: Constraint-Induced Movement Therapy (CIMT)

CARE-CITE Education Program Carepartners

EXPERIMENTAL

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

Behavioral: CARE-CITE Education Program

Traditional Education Carepartners

ACTIVE COMPARATOR

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

Behavioral: Traditional Education

Stroke Survivors with Traditional Education Carepartners

ACTIVE COMPARATOR

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.

Behavioral: Constraint-Induced Movement Therapy (CIMT)

Interventions

CARE-CITE Education Program BEHAVIORAL

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.

CARE-CITE Education Program Carepartners

Traditional Education BEHAVIORAL

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.

Traditional Education Carepartners

Constraint-Induced Movement Therapy (CIMT) BEHAVIORAL

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.

Stroke Survivors with CARE-CITE Carepartners; Stroke Survivors with Traditional Education Carepartners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Stroke Survivors
• Severe cognitive deficits
• Caregivers
• Significant cognitive deficits

Sponsors & Collaborators

• Emory University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• American Heart Association: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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.

  PMID: 31057807 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Results Point of Contact

• Title: Sarah Blanton, PT, DPT, NCS, FNAP
• Organization: Emory University

sblanto@emory.edu

404-712-2222

Study Officials

• Sarah Blanton

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 9, 2016
• Study Start: January 1, 2016
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: January 28, 2020
• Results First Posted: January 28, 2020

Record last verified: 2020-01

Locations

US (1)