Spinal Cord InjuryNCT00624806
Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D
A study testing Daily telephone calls and Weekly telephone calls in people with Spinal Cord Injury, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The Veteran's Health Administration (VHA) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Daily telephone calls and Weekly telephone calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Nov 2009
- Phase
- Interventional
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic
Who cannot join
- No phone
- Cognitive impairment
- Hearing impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
About this study
The Veteran's Health Administration (VHA) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).
Read the detailed description
Background:
VHA is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).
Objectives:
The goal of the study was to complete activities necessary in preparation for implementing a Home Telehealth program to manage veterans with SCI/D at risk of developing PrUs. Specifically this Rapid Response Project (RRP) included: 1) Convening an expert panel to validate Pressure Ulcer (PrU) PrU DMP items; 2) Developing a standardized protocol that specified how the nurse Care Coordinator who would manage patients who develop open skin wounds across the Hub and Spoke system of care; 3) Assessing individual telehealth DMP items by calling a sample of patients on a daily or weekly basis for up to 2 months to determine their validity and 4) Developing an instrument to assess staff satisfaction with this method of patient management.
Methods:
A convenience sample of veterans about to be discharged home from the Cleveland SCI/D inpatient unit were asked to participate in the study. This included patients living close to the Hub and those referred from spoke sites. Subjects were randomly assigned to receive either daily calls (5 days/week) for 40 total calls, or weekly calls (8 total calls) over the course of the 8 week/2month study intervention period.
Status:
The project team is conducting ongoing analysis of the data to develop publications.
- Conditions
- Spinal Cord Injury
- Being tested
- Daily telephone calls, Weekly telephone calls
- Keywords
- Pressure ulcer, Telemedicine
- Medical subject headings
- Spinal Cord Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily telephone callsBehavioural
Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
Weekly telephone callsBehavioural
Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
| Study group | Role | What they receive |
|---|---|---|
| Daily telephone calls | Experimental | Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers Receives: Behavioral: Daily telephone calls |
| Weekly telephone calls | Active comparator | Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers. Receives: Behavioral: Weekly telephone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Data
Data includes the number of triggered items and types of triggers.
Measured: Enrollment to study end, 8 weeks
Number of Days With Triggers at Certain Timeframe
Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.
Measured: Enrollment to study end, 8 weeks
Percent of Participant Triggering DMP Items
Percent of participants who triggered Disease-Management Protocol items by group.
Measured: Enrollment to study end, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marylou Guihan, PhD MA BA, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624806
- Sponsor's protocol ID
- RRP 07-292
- Status last verified
- Jul 2014
- First submitted
- 14 Feb 2008
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Woo C, Guihan M, Frick C, Gill CM, Ho CH. What's happening now! Telehealth management of spinal cord injury/disorders. J Spinal Cord Med. 2011;34(3):322-31. doi: 10.1179/2045772311Y.0000000003.
PubMed 21756573