Spinal Cord Injury Virtual Coach RCT

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876666
• Other study ID #: H-33729
• Secondary ID: 324644
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: July 26, 2017
• Start date: January 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2017
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

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.

Locations

Country	Name	City	State
United States	New England Regional SCI Center, Boston University School of Public Health	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	Northeastern University, The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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