Spinal Cord Injury Virtual Coach RCT

NCT ID: NCT02876666

Last Updated: 2017-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Coach Intervention

Group Type EXPERIMENTAL

SCI Virtual Coach

Intervention Type BEHAVIORAL

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

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Craig H. Neilsen Foundation

OTHER

Sponsor Role collaborator

Northeastern University

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy Latham, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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324644

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-33729

Identifier Type: -

Identifier Source: org_study_id

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