Spinal Cord InjuriesNCT02876666
Spinal Cord Injury Virtual Coach RCT
A study testing SCI Virtual Coach in people with Spinal Cord Injuries, run by Boston University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- SCI Virtual Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Moderate to severe cognitive impairment
- Expected to live less than 1 year
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Regional SCI Center, Boston University School of Public Health
Boston, Massachusetts, 02118
About this study
Official title: Spinal Cord Injury Virtual Coach to Promote Self-Care in Pressure Ulcer Prevention
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- SCI Virtual Coach
- Keywords
- Spinal Cord Injuries, Health Behavior
- Medical subject headings
- Spinal Cord Injuries, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCI Virtual CoachBehavioural
Participants are given a computer with the SCI Virtual Coach program and are asked to interact with the Coach daily for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Coach Intervention | Experimental | Not described Receives: Behavioral: SCI Virtual Coach |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Report at 2 month exit survey
Secondary outcomes (2)
Health Education Impact Questionnaire - Skill Technique Acquisition
Self-report measure of the participant's feelings about their ability to do skin behavior tasks
Measured: Baseline and 2 months
Skin Care Behavior Compliance
Self-report measure of compliance with behaviors to prevent skin care problems that lead to pressure ulcers
Measured: Baseline and two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJan 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Northeastern University
- Responsible party
- Sponsor
- Investigators
- Nancy Latham, PT, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876666
- Sponsor's protocol ID
- H-33729
- Other IDs
- 324644
- Status last verified
- Jul 2017
- First submitted
- 19 Aug 2016
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Injury Virtual Coach to Promote Self-Care in Pressure Ulcer Prevention
- ClinicalTrials.gov ID
- NCT02876666
- Acronym / sponsor ID
- H-33729
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Northeastern University
- Study start
- Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coach Intervention | Experimental | Behavioral: SCI Virtual Coach |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Moderate to severe cognitive impairment
- Expected to live less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCI Virtual CoachParticipants are given a computer with the SCI Virtual Coach program and are asked to interact with the Coach daily for 2 months. | Behavioural | Coach Intervention |
Primary outcome
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.
2 secondary outcomes
Health Education Impact Questionnaire - Skill Technique Acquisition
Time frame: Baseline and 2 months
Skin Care Behavior Compliance
Time frame: Baseline and two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Latham, PT, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCI Virtual Coach in people with Spinal Cord Injuries, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Usability Questionnaire (time frame: Report at 2 month exit survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.