Spinal Cord Injury Virtual Coach RCT

Study Overview
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Brief Summary
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The SCI Virtual Coach study has developed an on-screen, human-like character that will provide support, education and coaching to adults with spinal cord injury (SCI) to aid in the prevention of serious secondary conditions like pressure ulcers. In a randomized controlled trial, participants assigned to the Coach intervention will have a touch-screen computer placed in their homes and be asked to interact with the Coach on a daily basis for 2 months. Participants will be asked to complete surveys at baseline and 2 months. The SCI Virtual Coach study aims to measure how accessible and usable participants feel the Coach is, as well as participants' adherence to the Coach's instructions. It will also gauge how effective the Coach is in changing self-care knowledge, health care behaviors, self-efficacy for self-care, and perception of social support in participants.

Official Title
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Spinal Cord Injury Virtual Coach to Promote Self-Care in Pressure Ulcer Prevention

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: SCI Virtual Coach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-report of physician-confirmed chronic spinal cord injury diagnosis Injured within the last 6 months -10 years Speaks and understands conversational English Lives within approximately 1 hour of Boston, MA Exclusion Criteria: Moderate to severe cognitive impairment Expected to live less than 1 year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coach Intervention<br> | Behavioral: SCI Virtual Coach<br>* Participants are given a computer with the SCI Virtual Coach program and are asked to interact with the Coach daily for 2 months.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized Usability Questionnaire | Evaluates the participant's self-reported experiences with the Coach on a number of characteristics, including ease of use, repetitiveness, and overall satisfaction. | Report at 2 month exit survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Education Impact Questionnaire - Skill Technique Acquisition | Self-report measure of the participant's feelings about their ability to do skin behavior tasks | Baseline and 2 months | 
| Skin Care Behavior Compliance | Self-report measure of compliance with behaviors to prevent skin care problems that lead to pressure ulcers | Baseline and two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injuries, Health Behavior