Spinal Cord InjuryNCT00105859
Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)
A study testing Education and Counseling in people with Spinal Cord Injury and Pressure Ulcers, run by US Department of Veterans Affairs at 6 sites in United States.
Trial summary
Pressure ulcers are a serious, costly, and life-long complication of spinal cord injury (SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with SCI residing in the community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Pressure Ulcers
- What is being tested?
- Education and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- 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
- SCI more than 1 year duration, admitted to VA for treatment of a stage III or IV pressure ulcer, access to telephone for follow-up, understands english, cognitively intact
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
VA Medical Center, Augusta
Augusta, Georgia, 30904-6285
Houston VA Medical Center
Houston, Texas, 77030
Memphis, TN
Memphis, Tennessee, 38104
Clement J. Zablocki VAMC
Milwaukee, Wisconsin, 53295-1000
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
About this study
Pressure ulcers are a serious, costly, and life-long complication of spinal cord injury (SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with SCI residing in the community. Epidemiological studies have found that 36-50% of all persons with SCI who develop pressure ulcers will develop a recurrence within the first year after initial healing (Carlson et al., 1992; Fuhrer et al., 1993; Goldstein, 1998; Niazi et al., 1997; Salzberg et al. 1998). Recurrence rates have ranged from 21% to 79%, regardless of treatment (Schryvers et al., 2000; Goodman et al., 1999; Niazi et al., 1997). Pressure ulcer treatment is expensive. Surgical costs associated with pressure ulcer treatment can exceed $70,000 per case (Braun et al., 1992). VA administrative (National Patient Care Database, NPCD) data indicate that 41% of inpatient days in the SCI population are accounted for by either primary or secondary diagnoses of pressure ulcers or 23% of SCI inpatient days if restricted to primary diagnoses of pressure ulcers. Pressure ulcer recurrence has been associated with many factors including previous pressure ulcer surgery (Niazi et al., 1997). Although little data exist describing the factors associated with recurrence following surgery, some investigators reported recurrence rates of 11%-29% in cases with post-operative complications and 6% to 61% in cases without post-operative complications (Mandrekas \& Mastorakos, 1992; Relander \& Palmer, 1988; Disa et al., 1992). In a retrospective study of 48 veterans with SCI, investigators reported a 79% recurrence rate following surgery (Goodman et al., 1999).
Read the detailed description
Background:
Pressure ulcers are a serious, costly, and life-long complication of spinal cord injury (SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with SCI residing in the community. Epidemiological studies have found that 36-50% of all persons with SCI who develop pressure ulcers will develop a recurrence within the first year after initial healing (Carlson et al., 1992; Fuhrer et al., 1993; Goldstein, 1998; Niazi et al., 1997; Salzberg et al. 1998). Recurrence rates have ranged from 21% to 79%, regardless of treatment (Schryvers et al., 2000; Goodman et al., 1999; Niazi et al., 1997). Pressure ulcer treatment is expensive. Surgical costs associated with pressure ulcer treatment can exceed $70,000 per case (Braun et al., 1992). VA administrative (National Patient Care Database, NPCD) data indicate that 41% of inpatient days in the SCI population are accounted for by either primary or secondary diagnoses of pressure ulcers or 23% of SCI inpatient days if restricted to primary diagnoses of pressure ulcers. Pressure ulcer recurrence has been associated with many factors including previous pressure ulcer surgery (Niazi et al., 1997). Although little data exist describing the factors associated with recurrence following surgery, some investigators reported recurrence rates of 11%-29% in cases with post-operative complications and 6% to 61% in cases without post-operative complications (Mandrekas \& Mastorakos, 1992; Relander \& Palmer, 1988; Disa et al., 1992). In a retrospective study of 48 veterans with SCI, investigators reported a 79% recurrence rate following surgery (Goodman et al., 1999).
Objectives:
The purpose of this project was to identify effective interventions for reducing recurrent pressure ulcers, a severe costly complication in veterans with SCI. The effect of an educational and structured telephone counseling follow-up program on prevention and health care utilization were being evaluated. Hypotheses included the following: 1) After discharge from the hospital for treatment of a severe healed pelvic pressure ulcer, patients receiving the education and structured telephone counseling intervention would be significantly less likely to develop a new or recurrent severe (e.g., Stage III or IV), pelvic (defined for this study as occurring in the sacrum, coccyx, trochanter, or ischium) pressure ulcer than those receiving customary care. 2) Admissions and inpatient days for severe pelvic pressure ulcers will be significantly lower for veterans receiving the education and structured telephone counseling intervention when compared to those receiving customary care.
Methods:
Veterans admitted to 6 VA SCI Centers for medical and/or surgical treatment of a Stage III or IV pelvic pressure ulcer (sacrum, coccyx, trochanter or ischium) were randomly assigned to (1) an Intervention Group consisting of education plus structured telephone counseling follow-up or (2) a Customary Care (Control) group. Intervention Group subjects received a cognitive behavioral intervention based on the Trans-theoretical Stages of Change Model, which is designed to help individuals identify ways of improving health behaviors. On admission, interviewers collected information on demographics, health status/well being, locus of control, pressure ulcer knowledge, readiness-to-change, and health beliefs/practices. Some of these measures were re-administered prior to randomization and at 9 and 18 months post-discharge. Health care utilization was monitored for all participants for the length of the study. The primary outcome (dependent) variables were (1) the occurrence or non-occurrence of another pelvic pressure ulcer within 18 months of discharge following healing and, (2) for individuals who develop pressure ulcers during the study period, time to recurrence. Intervention Group participants were expected to have fewer pressure ulcer-related admissions and, if admitted, a shorter hospital stay. Secondary outcomes included health care utilization, pressure ulcer prevention knowledge, medical and psychological health status, health beliefs and practices, and quality of life. Multi-variate logistic models are being used to examine factors associated with recurrence and to evaluate the impact of recurrence on health care utilization.
Status:
A total of 64 patients were randomized in this study, 33 to customary care and 31 to the intervention group. Most were male, white, married and had their SCI at the thoracic level resulting in paraplegia. Mean time to recurrence was 114.50 days for the total randomized subjects. All data from all 15 questionnaires are being analyzed and will be put into a manuscript for publication at a future time.
- Conditions
- Spinal Cord Injury, Pressure Ulcers
- Being tested
- Education and Counseling
- 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.
Education and CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Behavioral: Education and Counseling |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Susan Garber, MA BS, Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105859
- Sponsor's protocol ID
- IIR 01-151
- Status last verified
- Jun 2005
- First submitted
- 17 Mar 2005
- Last updated
- 10 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Guihan M, Garber SL, Bombardier CH, Durazo-Arizu R, Goldstein B, Holmes SA. Lessons learned while conducting research on prevention of pressure ulcers in veterans with spinal cord injury. Arch Phys Med Rehabil. 2007 Jul;88(7):858-61. doi: 10.1016/j.apmr.2007.03.014.
PubMed 17601465Guihan M, Garber SL, Bombardier CH, Goldstein B, Holmes SA, Cao L. Predictors of pressure ulcer recurrence in veterans with spinal cord injury. J Spinal Cord Med. 2008;31(5):551-9. doi: 10.1080/10790268.2008.11754570.
PubMed 19086713Guihan M, Bombardier CH. Potentially modifiable risk factors among veterans with spinal cord injury hospitalized for severe pressure ulcers: a descriptive study. J Spinal Cord Med. 2012 Jul;35(4):240-50. doi: 10.1179/2045772312Y.0000000016.
PubMed 22925750
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT00105859
- Acronym / sponsor ID
- IIR 01-151
- Conditions
- Spinal Cord Injury, Pressure Ulcers
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- First posted
- 18 Mar 2005 (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.
Pressure ulcers are a serious, costly, and life-long complication of spinal cord injury (SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with SCI residing in the community. Epidemiological studies have found that 36-50% of all persons with SCI who develop pressure ulcers will develop a recurrence within the first year after initial healing (Carlson et al., 1992; Fuhrer et al., 1993; Goldstein, 1998; Niazi et al., 1997; Salzberg et al. 1998). Recurrence rates have ranged from 21% to 79%, regardless of treatment (Schryvers et al., 2000; Goodman et al., 1999; Niazi et al., 1997). Pressure ulcer treatment is expensive. Surgical costs associated with pressure ulcer treatment can exceed $70,000 per case (Braun et al., 1992). VA administrative (National Patient Care Database, NPCD) data indicate that 41% of inpatient days in the SCI population are accounted for by either primary or secondary diagnoses of pressure ulcers or 23% of SCI inpatient days if restricted to primary diagnoses of pressure ulcers. Pressure ulcer recurrence has been associated with many factors including previous pressure ulcer surgery (Niazi et al., 1997). Although little data exist describing the factors associated with recurrence following surgery, some investigators reported recurrence rates of 11%-29% in cases with post-operative complications and 6% to 61% in cases without post-operative complications (Mandrekas \& Mastorakos, 1992; Relander \& Palmer, 1988; Disa et al., 1992). In a retrospective study of 48 veterans with SCI, investigators reported a 79% recurrence rate following surgery (Goodman et al., 1999).
Detailed description
Background:
Pressure ulcers are a serious, costly, and life-long complication of spinal cord injury (SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with SCI residing in the community. Epidemiological studies have found that 36-50% of all persons with SCI who develop pressure ulcers will develop a recurrence within the first year after initial healing (Carlson et al., 1992; Fuhrer et al., 1993; Goldstein, 1998; Niazi et al., 1997; Salzberg et al. 1998). Recurrence rates have ranged from 21% to 79%, regardless of treatment (Schryvers et al., 2000; Goodman et al., 1999; Niazi et al., 1997). Pressure ulcer treatment is expensive. Surgical costs associated with pressure ulcer treatment can exceed $70,000 per case (Braun et al., 1992). VA administrative (National Patient Care Database, NPCD) data indicate that 41% of inpatient days in the SCI population are accounted for by either primary or secondary diagnoses of pressure ulcers or 23% of SCI inpatient days if restricted to primary diagnoses of pressure ulcers. Pressure ulcer recurrence has been associated with many factors including previous pressure ulcer surgery (Niazi et al., 1997). Although little data exist describing the factors associated with recurrence following surgery, some investigators reported recurrence rates of 11%-29% in cases with post-operative complications and 6% to 61% in cases without post-operative complications (Mandrekas \& Mastorakos, 1992; Relander \& Palmer, 1988; Disa et al., 1992). In a retrospective study of 48 veterans with SCI, investigators reported a 79% recurrence rate following surgery (Goodman et al., 1999).
Objectives:
The purpose of this project was to identify effective interventions for reducing recurrent pressure ulcers, a severe costly complication in veterans with SCI. The effect of an educational and structured telephone counseling follow-up program on prevention and health care utilization were being evaluated. Hypotheses included the following: 1) After discharge from the hospital for treatment of a severe healed pelvic pressure ulcer, patients receiving the education and structured telephone counseling intervention would be significantly less likely to develop a new or recurrent severe (e.g., Stage III or IV), pelvic (defined for this study as occurring in the sacrum, coccyx, trochanter, or ischium) pressure ulcer than those receiving customary care. 2) Admissions and inpatient days for severe pelvic pressure ulcers will be significantly lower for veterans receiving the education and structured telephone counseling intervention when compared to those receiving customary care.
Methods:
Veterans admitted to 6 VA SCI Centers for medical and/or surgical treatment of a Stage III or IV pelvic pressure ulcer (sacrum, coccyx, trochanter or ischium) were randomly assigned to (1) an Intervention Group consisting of education plus structured telephone counseling follow-up or (2) a Customary Care (Control) group. Intervention Group subjects received a cognitive behavioral intervention based on the Trans-theoretical Stages of Change Model, which is designed to help individuals identify ways of improving health behaviors. On admission, interviewers collected information on demographics, health status/well being, locus of control, pressure ulcer knowledge, readiness-to-change, and health beliefs/practices. Some of these measures were re-administered prior to randomization and at 9 and 18 months post-discharge. Health care utilization was monitored for all participants for the length of the study. The primary outcome (dependent) variables were (1) the occurrence or non-occurrence of another pelvic pressure ulcer within 18 months of discharge following healing and, (2) for individuals who develop pressure ulcers during the study period, time to recurrence. Intervention Group participants were expected to have fewer pressure ulcer-related admissions and, if admitted, a shorter hospital stay. Secondary outcomes included health care utilization, pressure ulcer prevention knowledge, medical and psychological health status, health beliefs and practices, and quality of life. Multi-variate logistic models are being used to examine factors associated with recurrence and to evaluate the impact of recurrence on health care utilization.
Status:
A total of 64 patients were randomized in this study, 33 to customary care and 31 to the intervention group. Most were male, white, married and had their SCI at the thoracic level resulting in paraplegia. Mean time to recurrence was 114.50 days for the total randomized subjects. All data from all 15 questionnaires are being analyzed and will be put into a manuscript for publication at a future time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Education and Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SCI more than 1 year duration, admitted to VA for treatment of a stage III or IV pressure ulcer, access to telephone for follow-up, understands english, cognitively intact
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Education and Counseling | Behavioural | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2010.
- Results publication: PubMed 17601465Guihan M, Garber SL, Bombardier CH, Durazo-Arizu R, Goldstein B, Holmes SA. Lessons learned while conducting research on prevention of pressure ulcers in veterans with spinal cord injury. Arch Phys Med Rehabil. 2007 Jul;88(7):858-61. doi: 10.1016/j.apmr.2007.03.014.
- Results publication: PubMed 19086713Guihan M, Garber SL, Bombardier CH, Goldstein B, Holmes SA, Cao L. Predictors of pressure ulcer recurrence in veterans with spinal cord injury. J Spinal Cord Med. 2008;31(5):551-9. doi: 10.1080/10790268.2008.11754570.
- Derived from this study: PubMed 22925750Guihan M, Bombardier CH. Potentially modifiable risk factors among veterans with spinal cord injury hospitalized for severe pressure ulcers: a descriptive study. J Spinal Cord Med. 2012 Jul;35(4):240-50. doi: 10.1179/2045772312Y.0000000016.
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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.
Susan Garber, MA BS principal investigator
Michael E. DeBakey VA Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Counseling in people with Spinal Cord Injury and Pressure Ulcers, run by US Department of Veterans Affairs at 6 sites 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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 10 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105859, which also lists 3 linked publications.
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 10 May 2010.