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Spinal Cord Injury Virtual Coach RCT

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02876666
Enrollment
40
Registered
2016-08-24
Start date
2017-01-31
Completion date
2017-06-30
Last updated
2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries, Health Behavior

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.

Interventions

BEHAVIORALSCI 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.

Sponsors

The Craig H. Neilsen Foundation
CollaboratorOTHER
Northeastern University
CollaboratorOTHER
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Standardized Usability QuestionnaireReport at 2 month exit surveyEvaluates the participant's self-reported experiences with the Coach on a number of characteristics, including ease of use, repetitiveness, and overall satisfaction.

Secondary

MeasureTime frameDescription
Health Education Impact Questionnaire - Skill Technique AcquisitionBaseline and 2 monthsSelf-report measure of the participant's feelings about their ability to do skin behavior tasks
Skin Care Behavior ComplianceBaseline and two monthsSelf-report measure of compliance with behaviors to prevent skin care problems that lead to pressure ulcers

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026