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Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)

Self-Management to Prevent Ulcers in Veterans With Spinal Cord Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00763282
Enrollment
144
Registered
2008-09-30
Start date
2008-11-30
Completion date
2011-12-31
Last updated
2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcers, Spinal Cord Injuries

Keywords

Spinal cord injuries, Pressure ulcers, Health behavior, self management, Rehabilitation, Outcome assessment, QUERI, Veterans

Brief summary

Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in FY10 was just under $400 million.

Detailed description

Background: Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in 2010 was just under $400 million. Objectives: The primary objective of this randomized clinical trial (RCT) was to determine whether a multi-component self-management (SM) intervention increases the use of skin-protective behaviors and reduces skin worsening in Veterans with SCI, compared to an education control (ED) intervention. Secondary outcomes included PrU knowledge, self-management skills, communication with providers, self-efficacy, community integration and days on bedrest. Another objective was to conduct focus group interviews with patients and providers and to analyze transcripts of SM group sessions to determine barriers and facilitators with regard to spinal cord injury and pressure ulcer prevention. Methods: This was a multi-site efficacy intervention study with a single blind prospective randomized design. Descriptive statistics were used to summarize demographic and key variables. Supplemental focus group interviews were conducted with patients with SCI (n=35) and SCI providers (n=39). Focus group interviews and SM group calls were transcribed verbatim and analyzed using constant comparative techniques. Study participants included Veterans hospitalized for Stage III/IV PrUs at or below the level of injury, from six VA SCI Centers around the country (Long Beach, Houston, Milwaukee, Augusta, Hines and St. Louis). Prior to discharge, PrU risk factors were identified and 1:1 PrU education was provided. Randomization and the behavioral interventions began at discharge. The number of randomized subjects were 72 in the ED group and 72 in the SM group (n=144). The analytic sample included subjects with complete data (n=92). The intervention included 8 site coordinator-initiated calls using didactic (ED) or Motivational Interviewing (MI) strategies to address PrU risk factors. The second component included telephone group calls that included either didactic information about SCI or SM skills including: 1) knowledge about the medical condition; 2) self-monitoring; 3) problem-solving skills; 4) skill for managing the effects of the condition; 5) adherence to necessary health behaviors; and 6) self-advocacy with health care providers. ED subjects received general health information and were not instructed in any specific problem solving, self-monitoring or SM techniques. The ED intervention was comparable to the SM with respect to natural history/ time, dosing, measurement processes, attention, therapeutic alliance, social support, and in receiving a manualized treatment with specific therapist procedures. Self-reported outcome data were obtained by phone at 3 and 6 months, and from mailed photos of study ulcers. Status: Study is complete. Additional analyses are ongoing and future manuscripts are planned.

Interventions

BEHAVIORALSelf Management (SM)

Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.

BEHAVIORALMotivational Interviewing (MI)

Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures.

BEHAVIORALEducation (ED)

The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* over 18 years of age, * SCI of at least six month's duration, * hospitalized for a Stage III or IV PrU, * cognitively intact, * available for telephone follow-up, and * discharged to a community setting or able to direct own care.

Exclusion criteria

We excluded patients with a terminal diagnosis, severe psychiatric comorbidities (eg, current psychosis), cognitive impairments that limited their ability to consent or participate, severe hearing loss, and wounds not expected to heal. People discharged to nursing homes unable to direct their own care were also excluded.

Design outcomes

Primary

MeasureTime frameDescription
Percent of Possible Self-Reported Skin Care BehaviorsAdmission (Baseline), 3 months, 6 monthsSkin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline). The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge.
Skin Behavior ChangeAdmission (Baseline), 3 months, 6 monthsSelf-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms. The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge.
Any Skin Worsening6 monthsSkin worsening was defined as when a participant with an open wound at the time of discharge is found to have \>20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.
Skin StatusAdmission (Baseline), 3 months, 6 monthsSkin worsening was defined as when a participant with an open wound at the time of discharge is found to have \>20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.

Secondary

MeasureTime frameDescription
Mean Number of Skin-related AdmissionsDischarge to end of study (6 months)Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown.

Countries

United States

Participant flow

Participants by arm

ArmCount
Self Management (SM) + Motivational Interviewing (MI)
Self Management (SM) + Motivational Interviewing (MI) Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology.
71
Education (ED)
Education (ED) Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
72
Total143

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath43
Overall StudyLost to Follow-up2226
Overall StudyWithdrawal by Subject65

Baseline characteristics

CharacteristicEducation (ED)TotalSelf Management (SM) + Motivational Interviewing (MI)
Age, Continuous59.0 years59.3 years59.4 years
American Spinal Injury Association (ASIA) Score
A = Complete
48 participants101 participants53 participants
American Spinal Injury Association (ASIA) Score
B = Sensory Incomplete
8 participants15 participants7 participants
American Spinal Injury Association (ASIA) Score
C = Motor Incomplete
10 participants17 participants7 participants
American Spinal Injury Association (ASIA) Score
D = Motor Incomplete
6 participants10 participants4 participants
Comorbid Conditions (baseline)
Depression
29 participants58 participants29 participants
Comorbid Conditions (baseline)
Diabetes
22 participants56 participants34 participants
Comorbid Conditions (baseline)
Osteomyelitis
10 participants28 participants18 participants
Current Employment
Employed
11 participants22 participants11 participants
Current Employment
Unemployed
61 participants121 participants60 participants
Duration of Spinal Cord Injury24.0 years24.0 years23.8 years
Educational Level
College Graduate
9 participants19 participants10 participants
Educational Level
Graduate School
3 participants6 participants3 participants
Educational Level
High School Graduate or Lower
22 participants45 participants23 participants
Educational Level
Some College
38 participants73 participants35 participants
Etiology
Diving
4 participants9 participants5 participants
Etiology
Driving
35 participants70 participants35 participants
Etiology
Fall
6 participants11 participants5 participants
Etiology
Gunshot Wound
11 participants17 participants6 participants
Etiology
Other
16 participants36 participants20 participants
History of PrUs56 participants112 participants56 participants
Hospital-acquired PrU9 Pressure Ulcers21 Pressure Ulcers12 Pressure Ulcers
Level of Injury
Cervical
30 participants60 participants30 participants
Level of Injury
Lumbar
6 participants7 participants1 participants
Level of Injury
Thoracic
36 participants76 participants40 participants
Locations of Current Pressure Ulcers
Coccyx
6 Pressure Ulcers15 Pressure Ulcers9 Pressure Ulcers
Locations of Current Pressure Ulcers
Ischium
38 Pressure Ulcers78 Pressure Ulcers40 Pressure Ulcers
Locations of Current Pressure Ulcers
Other locations (e.g., feet)
16 Pressure Ulcers32 Pressure Ulcers16 Pressure Ulcers
Locations of Current Pressure Ulcers
Sacrum
13 Pressure Ulcers28 Pressure Ulcers15 Pressure Ulcers
Locations of Current Pressure Ulcers
Trochanter
9 Pressure Ulcers20 Pressure Ulcers11 Pressure Ulcers
Marital Status
Divorced
27 participants52 participants25 participants
Marital Status
Live with Partner
1 participants1 participants0 participants
Marital Status
Married
28 participants57 participants29 participants
Marital Status
Missing
0 participants1 participants1 participants
Marital Status
Never Married
10 participants21 participants11 participants
Marital Status
Widowed
6 participants11 participants5 participants
Pressure Ulcer (PrU) Characteristics
Number of current PrUs
1.3 Pressure Ulcers1.4 Pressure Ulcers1.6 Pressure Ulcers
Pressure Ulcer (PrU) Characteristics
Number of prior PrUs
1.93 Pressure Ulcers2.41 Pressure Ulcers2.89 Pressure Ulcers
Prior PrU Surgery
No
26 participants46 participants20 participants
Prior PrU Surgery
Yes
46 participants97 participants51 participants
PrU Duration for Largest PrU407 days
STANDARD_DEVIATION 631
307 days
STANDARD_DEVIATION 482
213 days
STANDARD_DEVIATION 244
PrU Size of Largest Ulcer4.5 cm^26.3 cm^28.2 cm^2
Race/Ethnicity, Customized
Black
18 participants38 participants20 participants
Race/Ethnicity, Customized
Hispanic
2 participants6 participants4 participants
Race/Ethnicity, Customized
Other
0 participants1 participants1 participants
Race/Ethnicity, Customized
White
52 participants98 participants46 participants
Residence Type
Apartment
12 participants27 participants15 participants
Residence Type
House
56 participants106 participants50 participants
Residence Type
Nursing Home
0 participants1 participants1 participants
Residence Type
Other
4 participants9 participants5 participants
Salzburg PrU Risk Score9.3 Scores on a scale9.5 Scores on a scale9.8 Scores on a scale
Sex: Female, Male
Female
2 Participants4 Participants2 Participants
Sex: Female, Male
Male
70 Participants139 Participants69 Participants
Source of Assistance
No Regular Assistance
11 participants23 participants12 participants
Source of Assistance
Other Regular Assistance
8 participants13 participants5 participants
Source of Assistance
Paid Attendant
18 participants48 participants30 participants
Source of Assistance
Spouse; partner/significant other; Relative
45 participants95 participants50 participants
Stage of PrUs at randomization
Stage III = Full thickness
31 Pressure Ulcers53 Pressure Ulcers22 Pressure Ulcers
Stage of PrUs at randomization
Stage IV = Full thickness
43 Pressure Ulcers97 Pressure Ulcers54 Pressure Ulcers

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 720 / 72
serious
Total, serious adverse events
4 / 723 / 72

Outcome results

Primary

Any Skin Worsening

Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have \>20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Self Management (SM) + Motivational Interviewing (MI)Any Skin WorseningNo36 participants
Self Management (SM) + Motivational Interviewing (MI)Any Skin WorseningYes35 participants
Education (ED)Any Skin WorseningNo33 participants
Education (ED)Any Skin WorseningYes39 participants
Primary

Percent of Possible Self-Reported Skin Care Behaviors

Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline). The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge.

Time frame: Admission (Baseline), 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Self Management (SM) + Motivational Interviewing (MI)Percent of Possible Self-Reported Skin Care BehaviorsAdmission73.8 % of Possible Self-Reported BehaviorsStandard Deviation 23.3
Self Management (SM) + Motivational Interviewing (MI)Percent of Possible Self-Reported Skin Care Behaviors3 Months83.5 % of Possible Self-Reported BehaviorsStandard Deviation 17.5
Self Management (SM) + Motivational Interviewing (MI)Percent of Possible Self-Reported Skin Care Behaviors6 Months85.0 % of Possible Self-Reported BehaviorsStandard Deviation 15.2
Education (ED)Percent of Possible Self-Reported Skin Care BehaviorsAdmission74.1 % of Possible Self-Reported BehaviorsStandard Deviation 18.6
Education (ED)Percent of Possible Self-Reported Skin Care Behaviors3 Months79.5 % of Possible Self-Reported BehaviorsStandard Deviation 19.6
Education (ED)Percent of Possible Self-Reported Skin Care Behaviors6 Months83.0 % of Possible Self-Reported BehaviorsStandard Deviation 14.6
Primary

Skin Behavior Change

Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms. The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge.

Time frame: Admission (Baseline), 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Self Management (SM) + Motivational Interviewing (MI)Skin Behavior ChangeBaseline to 3 months9.7 % ChangeStandard Deviation 19.3
Self Management (SM) + Motivational Interviewing (MI)Skin Behavior ChangeBaseline to 6 months11.3 % ChangeStandard Deviation 20
Education (ED)Skin Behavior ChangeBaseline to 6 months8.9 % ChangeStandard Deviation 18.1
Education (ED)Skin Behavior ChangeBaseline to 3 months5.4 % ChangeStandard Deviation 22.9
Primary

Skin Status

Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have \>20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.

Time frame: Admission (Baseline), 3 months, 6 months

ArmMeasureGroupValue (NUMBER)
Self Management (SM) + Motivational Interviewing (MI)Skin StatusWorse 4-6 Months9 participants
Self Management (SM) + Motivational Interviewing (MI)Skin StatusNo Skin Worsening36 participants
Self Management (SM) + Motivational Interviewing (MI)Skin StatusWorse 0-3 Months26 participants
Education (ED)Skin StatusWorse 0-3 Months28 participants
Education (ED)Skin StatusWorse 4-6 Months11 participants
Education (ED)Skin StatusNo Skin Worsening33 participants
Secondary

Mean Number of Skin-related Admissions

Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown.

Time frame: Discharge to end of study (6 months)

Population: Mean number of skin-related post-discharge admissions (ICD9 code =707.xx)

ArmMeasureValue (MEAN)Dispersion
Self Management (SM) + Motivational Interviewing (MI)Mean Number of Skin-related Admissions1.5 admissions/participantStandard Deviation 0.8
Education (ED)Mean Number of Skin-related Admissions1.6 admissions/participantStandard Deviation 0.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026