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Spinal Cord InjuriesPhase 3PUPSNCT01999816

Pressure Ulcer Prevention Study in SCI

A Phase 3 study testing Lifestyle Redesign in people with Spinal Cord Injuries, run by University of Southern California at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to conduct a randomized controlled trial of a lifestyle redesign intervention's ability to (1)reduce the incidence of medically serious pressure ulcers and associated surgeries in adults with spinal cord injury, and (2)assess the intervention's cost-effectiveness and potential cost savings… 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?
Lifestyle Redesign
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
2 sitesUnited States
Study dates
Sep 2008to Sep 2015
Phase
Phase 3
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

  • Spinal cord injury (paraplegia or tetraplegia)
  • Non-ambulatory
  • Able to undergo intervention and testing in English or Spanish
  • At least 6 months post-injury
  • History of at least one serious (Stage 3 or 4) pressure ulcer in the past 5 years
  • Cognitively intact
Show all 10Show fewer
  • Personally expressed willingness to undertake recommended lifestyle changes for ulcer prevention.
  • Can be reached by telephone.
  • Reside in or within 100 miles of Rancho Los Amigos National Rehabilitation Center (Downey, CA) with no plans to relocate beyond this area.
  • Agreement to participate and completion of consent form.

Who cannot join

  • Present serious stage 4 pressure ulcer
  • Participation in our preliminary research studies
  • Participating in the neuromuscular stimulation study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rancho Los Amigos National Rehabilitation Center (RLANRC)

    Downey, California, 90242

  • University of Southern California

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury

The purpose of this study is to conduct a randomized controlled trial of a lifestyle redesign intervention's ability to (1)reduce the incidence of medically serious pressure ulcers and associated surgeries in adults with spinal cord injury, and (2)assess the intervention's cost-effectiveness and potential cost savings and its effects on participants' quality of life.

Read the detailed description

Medically serious pressure ulcers are a common complication of spinal cord injury (SCI), and are associated with high treatment costs and reduced quality of life. This study will examine the efficacy and cost-effectiveness of a promising lifestyle-based intervention designed to reduce the incidence of pressure ulcers among culturally diverse, community dwelling adults with SCI who have had serious pressure ulcers.

The intervention being tested, termed lifestyle redesign (LR), is based on prior SCI literature as well as on the results of a qualitative pilot study undertaken by our study group. This intervention targets several psychosocial mediating variables that have been shown to be important in prevention of pressure ulcers in daily living contexts. Participants assigned to the LR condition receive individualized in-home sessions, personal phone calls, and incident-based contacts for a 12-month period, followed by 12 months of no intervention. Participants in the control condition do not receive any study-based intervention, but (along with the LR group) have continuing access to the standard options for prevention and treatment that are available through Rancho Los Amigos National Rehabilitation Center.

In addition to identifying a pressure ulcer prevention strategy, the planned research will lead to the development of testable theoretical models of the intervening process mechanisms that link the intervention to pressure ulcer reduction.

Being tested
Lifestyle Redesign
Keywords
pressure ulcer, lifestyle redesign, spinal cord injury
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.

  • Lifestyle RedesignBehavioural

    Also called Occupational therapy

    Individualized program for lifestyle redesign aimed at decreasing the risk of medically serious pressure ulcers led by licensed occupational therapists trained in the implementation of the lifestyle redesign program

Study groups in NCT01999816
Study groupRoleWhat they receive
Lifestyle RedesignExperimentalOccupational therapist led lifestyle redesign program to prevent pressure ulcers
Receives: Behavioral: Lifestyle Redesign
ControlNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of serious pressure ulcers

    New stage 3 or 4 pressure ulcers

    Measured: Throughout 12-month study intervention

Secondary outcomes (5)

  1. Incidence of ulcer related surgeries

    Surgical wound repair (flap, skin graft, girdlestone, other)

    Measured: Throughout 12-month study intervention and 12-months post intervention period

  2. Quality of life

    Measured by the Medical Outcomes Study Short Form (SF-36)

    Measured: Throughout 12-month study intervention and 12-months post intervention period

  3. Healthcare service utilization

    Estimated cost of healthcare services including inpatient, outpatient, ER, home healthcare, lab, imaging, etc.

    Measured: Throughout 12-month study intervention and 12-months post intervention period

  4. Incidence of serious pressure ulcers

    New stage 3 or 4 pressure ulcers during the second study year

    Measured: Throughout 12-months post intervention period

  5. Life Satisfaction

    Measured by the Satisfaction with Life Scale (SWLS)

    Measured: Throughout 12-month study intervention and 12-months post intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2013 (estimated)
  2. Study startSep 2008
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01999816
Sponsor's protocol ID
HS-06-00064
Other IDs
R01HD056267
Acronym
PUPS
Status last verified
Oct 2016
First submitted
25 Nov 2013
Last updated
27 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: We will submit de-identified data to ICPSR

Publications

  • Pyatak EA, Blanche EI, Garber SL, Diaz J, Blanchard J, Florindez L, Clark FA. Conducting intervention research among underserved populations: lessons learned and recommendations for researchers. Arch Phys Med Rehabil. 2013 Jun;94(6):1190-8. doi: 10.1016/j.apmr.2012.12.009. Epub 2012 Dec 21.

    PubMed 23262157

  • Blanche EI, Fogelberg D, Diaz J, Carlson M, Clark F. Manualization of occupational therapy interventions: illustrations from the pressure ulcer prevention research program. Am J Occup Ther. 2011 Nov-Dec;65(6):711-9. doi: 10.5014/ajot.2011.001172.

    PubMed 22214116

  • Vaishampayan A, Clark F, Carlson M, Blanche EI. Preventing pressure ulcers in people with spinal cord injury: targeting risky life circumstances through community-based interventions. Adv Skin Wound Care. 2011 Jun;24(6):275-84; quiz 285-6. doi: 10.1097/01.ASW.0000398663.66530.46.

    PubMed 21586911

  • Fogelberg D, Atkins M, Blanche EI, Carlson M, Clark F. Decisions and Dilemmas in Everyday Life: Daily Use of Wheelchairs by Individuals with Spinal Cord Injury and the Impact on Pressure Ulcer Risk. Top Spinal Cord Inj Rehabil. 2009 Fall;15(2):16-32. doi: 10.1310/sci1502-16.

    PubMed 21603085

  • Clark F, Pyatak EA, Carlson M, Blanche EI, Vigen C, Hay J, Mallinson T, Blanchard J, Unger JB, Garber SL, Diaz J, Florindez LI, Atkins M, Rubayi S, Azen SP; PUPS Study Group. Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS). Clin Trials. 2014 Apr;11(2):218-29. doi: 10.1177/1740774514521904. Epub 2014 Feb 26.

    PubMed 24577972

  • Blanchard J, Vigen C, Mallinson T, Carlson M, Garber SL, Bates-Jensen B. Pressure Injury Data Reconciliation in a Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 Nov;104(11):1833-1839. doi: 10.1016/j.apmr.2023.04.009. Epub 2023 Apr 28.

    PubMed 37121533

  • Carlson M, Vigen CLP, Rubayi S, Blanche EI, Blanchard J, Atkins M, Bates-Jensen B, Garber SL, Pyatak EA, Diaz J, Florindez LI, Hay JW, Mallinson T, Unger JB, Azen SP, Scott M, Cogan A, Clark F. Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study. J Spinal Cord Med. 2019 Jan;42(1):2-19. doi: 10.1080/10790268.2017.1313931. Epub 2017 Apr 17.

    PubMed 28414254

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lifestyle Redesign in people with Spinal Cord Injuries, run by University of Southern California at 2 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 10 inclusion and 3 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Incidence of serious pressure ulcers (time frame: Throughout 12-month study intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01999816, which also lists 7 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 27 Oct 2016.

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Pressure Ulcer Prevention Study in SCI (NCT01999816) | AzTrials