NCT01999816

Brief 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 and its effects on participants' quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_3

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

September 1, 2008

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

7 years

First QC Date

November 25, 2013

Last Update Submit

October 26, 2016

Conditions

Spinal Cord Injuries

Keywords

pressure ulcerlifestyle redesignspinal cord injury

Outcome Measures

Primary Outcomes (1)

  • Incidence of serious pressure ulcers

    New stage 3 or 4 pressure ulcers

    Throughout 12-month study intervention

Secondary Outcomes (5)

  • Incidence of ulcer related surgeries

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

  • Quality of life

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

  • Healthcare service utilization

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

  • Incidence of serious pressure ulcers

    Throughout 12-months post intervention period

  • Life Satisfaction

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

Study Arms (2)

Lifestyle Redesign

EXPERIMENTAL

Occupational therapist led lifestyle redesign program to prevent pressure ulcers

Behavioral: Lifestyle Redesign

Control

NO INTERVENTION

Usual care

Interventions

Lifestyle RedesignBEHAVIORAL

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

Also known as: Occupational therapy
Lifestyle Redesign

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rancho Los Amigos National Rehabilitation Center (RLANRC)

Downey, California, 90242, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (7)

  • 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.

    PMID: 23262157BACKGROUND

  • 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.

    PMID: 22214116BACKGROUND

  • 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.

    PMID: 21586911BACKGROUND

  • 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.

    PMID: 21603085BACKGROUND

  • 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.

    PMID: 24577972BACKGROUND

  • 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.

    PMID: 37121533DERIVED

  • 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.

    PMID: 28414254DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesPressure Ulcer

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Florence Clark, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Salah Rubayi, MD

    Rancho Los Amigos National Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean, Chair, and Professor Occupational Science and Occupational Therapy

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 3, 2013

Study Start

September 1, 2008

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

We will submit de-identified data to ICPSR

Locations

US(2)