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Spinal Cord Injury Virtual Coach RCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02876666
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : July 28, 2017
Sponsor:
Collaborators:
The Craig H. Neilsen Foundation
Northeastern University
Information provided by (Responsible Party):
Boston University

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: SCI Virtual Coach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
New England Regional SCI Center, Boston University School of Public Health
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
The Craig H. Neilsen Foundation
Northeastern University
Investigators
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Principal Investigator: Nancy Latham, PT, PhD Boston University

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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT02876666     History of Changes
Other Study ID Numbers: H-33729
324644 ( Other Grant/Funding Number: Craig H. Neilsen Foundation )
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston University:
Spinal Cord Injuries
Health Behavior

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System