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Pressure Ulcer Prevention Study in SCI (PUPS)

26. oktober 2016 opdateret af: Florence Clark, University of Southern California

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

170

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Downey, California, Forenede Stater, 90242
        • Rancho Los Amigos National Rehabilitation Center (RLANRC)
      • Los Angeles, California, Forenede Stater, 90033
        • University of Southern California

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Sædvanlig pleje
Eksperimentel: Lifestyle Redesign
Occupational therapist led lifestyle redesign program to prevent pressure ulcers
Adfærdsmæssigt: Lifestyle Redesign
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
Andre navne:
  • Ergoterapi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of serious pressure ulcers
Tidsramme: Throughout 12-month study intervention
New stage 3 or 4 pressure ulcers
Throughout 12-month study intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of ulcer related surgeries
Tidsramme: Throughout 12-month study intervention and 12-months post intervention period
Surgical wound repair (flap, skin graft, girdlestone, other)
Throughout 12-month study intervention and 12-months post intervention period
Quality of life
Tidsramme: Throughout 12-month study intervention and 12-months post intervention period
Measured by the Medical Outcomes Study Short Form (SF-36)
Throughout 12-month study intervention and 12-months post intervention period
Healthcare service utilization
Tidsramme: Throughout 12-month study intervention and 12-months post intervention period
Estimated cost of healthcare services including inpatient, outpatient, ER, home healthcare, lab, imaging, etc.
Throughout 12-month study intervention and 12-months post intervention period
Incidence of serious pressure ulcers
Tidsramme: Throughout 12-months post intervention period
New stage 3 or 4 pressure ulcers during the second study year
Throughout 12-months post intervention period
Life Satisfaction
Tidsramme: Throughout 12-month study intervention and 12-months post intervention period
Measured by the Satisfaction with Life Scale (SWLS)
Throughout 12-month study intervention and 12-months post intervention period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Southern California

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

  • Ledende efterforsker: Florence Clark, PhD, University of Southern California
  • Ledende efterforsker: Salah Rubayi, MD, Rancho Los Amigos National Rehabilitation Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2008

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

25. november 2013

Først indsendt, der opfyldte QC-kriterier

25. november 2013

Først opslået (Skøn)

3. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HS-06-00064
  • R01HD056267 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

We will submit de-identified data to ICPSR

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rygmarvsskader

Kliniske forsøg med Lifestyle Redesign

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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