Spinal Cord Injury Virtual Coach RCT
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|ClinicalTrials.gov Identifier: NCT02876666|
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : July 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Behavioral: SCI Virtual Coach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Spinal Cord Injury Virtual Coach to Promote Self-Care in Pressure Ulcer Prevention|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
|Experimental: Coach Intervention||
Behavioral: SCI Virtual Coach
Participants are given a computer with the SCI Virtual Coach program and are asked to interact with the Coach daily for 2 months.
|No Intervention: Usual Care|
- Standardized Usability Questionnaire [ Time Frame: Report at 2 month exit survey ]Evaluates the participant's self-reported experiences with the Coach on a number of characteristics, including ease of use, repetitiveness, and overall satisfaction.
- Health Education Impact Questionnaire - Skill Technique Acquisition [ Time Frame: Baseline and 2 months ]Self-report measure of the participant's feelings about their ability to do skin behavior tasks
- Skin Care Behavior Compliance [ Time Frame: Baseline and two months ]Self-report measure of compliance with behaviors to prevent skin care problems that lead to pressure ulcers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876666
|United States, Massachusetts|
|New England Regional SCI Center, Boston University School of Public Health|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Nancy Latham, PT, PhD||Boston University|