Back to resultsSpinal Cord Injury Virtual Coach RCT
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCI Virtual Coach
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Health Behavior
Eligibility Criteria
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
Sites / Locations
- New England Regional SCI Center, Boston University School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Coach Intervention
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Health Education Impact Questionnaire - Skill Technique Acquisition
Self-report measure of the participant's feelings about their ability to do skin behavior tasks
Skin Care Behavior Compliance
Self-report measure of compliance with behaviors to prevent skin care problems that lead to pressure ulcers
Full Information
NCT ID
NCT02876666
First Posted
August 19, 2016
Last Updated
July 26, 2017
Sponsor
Boston University
Collaborators
The Craig H. Neilsen Foundation, Northeastern University
1. Study Identification
Unique Protocol Identification Number
NCT02876666
Brief Title
Spinal Cord Injury Virtual Coach RCT
Official Title
Spinal Cord Injury Virtual Coach to Promote Self-Care in Pressure Ulcer Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
The Craig H. Neilsen Foundation, Northeastern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injuries, Health Behavior
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coach Intervention
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
SCI Virtual Coach
Intervention Description
Participants are given a computer with the SCI Virtual Coach program and are asked to interact with the Coach daily for 2 months.
Primary Outcome Measure Information:
Title
Standardized Usability Questionnaire
Description
Evaluates the participant's self-reported experiences with the Coach on a number of characteristics, including ease of use, repetitiveness, and overall satisfaction.
Time Frame
Report at 2 month exit survey
Secondary Outcome Measure Information:
Title
Health Education Impact Questionnaire - Skill Technique Acquisition
Description
Self-report measure of the participant's feelings about their ability to do skin behavior tasks
Time Frame
Baseline and 2 months
Title
Skin Care Behavior Compliance
Description
Self-report measure of compliance with behaviors to prevent skin care problems that lead to pressure ulcers
Time Frame
Baseline and two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Latham, PT, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New England Regional SCI Center, Boston University School of Public Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Spinal Cord Injury Virtual Coach RCT
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