Spinal Cord Injury Virtual Coach RCT
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedJuly 28, 2017
July 1, 2017
6 months
August 19, 2016
July 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Health Education Impact Questionnaire - Skill Technique Acquisition
Baseline and 2 months
Skin Care Behavior Compliance
Baseline and two months
Study Arms (2)
Coach Intervention
EXPERIMENTALUsual Care
NO INTERVENTIONInterventions
Participants are given a computer with the SCI Virtual Coach program and are asked to interact with the Coach daily for 2 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Moderate to severe cognitive impairment
- Expected to live less than 1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- The Craig H. Neilsen Foundationcollaborator
- Northeastern Universitycollaborator
Study Sites (1)
New England Regional SCI Center, Boston University School of Public Health
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Latham, PT, PhD
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2016
First Posted
August 24, 2016
Study Start
January 1, 2017
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
July 28, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share