NCT00624806

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

December 5, 2014

Completed
Last Updated

April 28, 2015

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

February 14, 2008

Results QC Date

July 25, 2014

Last Update Submit

April 6, 2015

Conditions

Spinal Cord Injury

Keywords

Pressure ulcerTelemedicine

Outcome Measures

Primary Outcomes (3)

  • Days of Data

    Data includes the number of triggered items and types of triggers.

    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.

    Enrollment to study end, 8 weeks

  • Percent of Participant Triggering DMP Items

    Percent of participants who triggered Disease-Management Protocol items by group.

    Enrollment to study end, 8 weeks

Study Arms (2)

Daily telephone calls

EXPERIMENTAL

Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers

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.

Behavioral: Weekly telephone calls

Interventions

Daily telephone callsBEHAVIORAL

Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.

Daily telephone calls
Weekly telephone callsBEHAVIORAL

Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.

Weekly telephone calls

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic

You may not qualify if:

  • No phone
  • Cognitive impairment
  • Hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • 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.

    PMID: 21756573RESULT

MeSH Terms

Conditions

Spinal Cord InjuriesPressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

The study duration was short and the sample was small. Because we only studied subjects who received the DMP, it is unknown how many would have had skin breakdown in a comparable period without the DMP.

Results Point of Contact

Title
Marylou Guihan, PhD
Organization
Center of Innovation for Complex Chronic Health Care
marylou.guihan@va.gov
708-202-2414

Study Officials

  • Marylou Guihan, PhD MA BA

    Edward Hines Jr. VA Hospital, Hines, IL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 27, 2008

Study Start

February 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

April 28, 2015

Results First Posted

December 5, 2014

Record last verified: 2014-07

Locations

US(2)