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OpenTrials
Completed

NCT Number: NCT02876666

Spinal Cord Injury Virtual Coach RCT

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.

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Key information

Conditions

Spinal Cord Injuries Behavior Central Nervous System Diseases Health Behavior Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New England Regional SCI Center, Boston University School of Public Health

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SCI Virtual Coach

Behavioral

Participants are given a computer with the SCI Virtual Coach program and are asked to interact with the Coach daily for 2 months.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Northeastern University
  • The Craig H. Neilsen Foundation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2016
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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