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Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents (STOOL)

22. november 2010 opdateret af: Synergy Health Solutions

Surveying The Outcomes Of Lubiprostone (The STOOL Study): The Effect of Lubiprostone on Reducing the Number of Medications Prescribed to Nursing Home Residents and Its Impact on Selected Quality Indicators

The purpose is to assess the efficacy, clinical outcomes, and potential Quality Indicator benefits associated with the use of Lubiprostone in nursing home residents with a confirmed diagnosis of chronic idiopathic constipation.

Studieoversigt

Status

Trukket tilbage

Betingelser

Forstoppelse

Detaljeret beskrivelse

The study is a prospective, observational, open-label, non-placebo, controlled study to measure the effects of Lubiprostone on CIC in nursing home residents. All clinical sites will follow a common protocol using standardizes definitions in which eligible patients will be asked to participate in the proposed study. During the course of the study, various selected parameters will be measured and compared to establish the clinical efficacy of Lubiprostone in the treatment of CIC.

The study sample (N=105) will be comprised of nursing home residents with a confirmed diagnosis of CIC. A power analysis generated a sample size of 97 residents. To protect the validity of the test, 8 residents were added to the final study sample to allow for losses to followup. Therefore, a final sample size of 105 residents was identified for the study.

Patients meeting the inclusion criteria will be recruited for participation in the study. 3 sites in Central Florida with multiple Nursing Homes per site will be recruited to participate in the proposed study.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

105

Kontakter og lokationer

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

Studiesteder

Forenede Stater
- Florida
  - Brooksville, Florida, Forenede Stater
    - Geriatric Medical Associates
  - Casselberry, Florida, Forenede Stater
    - Cassellberry Family Practice
  - Melbourne, Florida, Forenede Stater
    - Osler Geriatrics

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Nursing Home Residents (adult subjects living in Nursing Homes)

Beskrivelse

Inclusion Criteria:

Patients must meet all of the following criteria to be eligible for the study:

Adult men and women nursing home residents;
Confirmed diagnosis of CIC using Rome criteria;
Prescribed two or more laxatives, at recruitment;
Taking 9 or more oral medicines (including prescription, OTC and prn)
Free from conditions likely to be fatal within six months;
Able to read or understand English; and
Able and willing to provide informed consent or has a guardian/agent who can provide consent.

Exclusion Criteria:

Currently pregnant;
Presence of megacolon;
Presence of rectal sigmoid cancer;
Presence of colon cancer;
Presence of anal incompetence;
Conditions likely to be fatal within six months;
Taking 8 or fewer medicines;
Enrolled in hospice;
Non-English speaking patients; and
Unwilling or unable to provide informed consent and has no guardian/agent.
Expected to be discharged within 3 months.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
Lubiprostone Subjects switching from current bowel medicines to lubiprostone

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
To determine the overall reduction in the number of oral medicines taken by each NH resident at enrollment and at 60 days. Tidsramme: 60 days	60 days

Sekundære resultatmål

Resultatmål	Tidsramme
Reduce the number of oral medicines being taken by any nursing home resident from 9 or more to fewer than 9. (Quality Indicator Number 6) Tidsramme: 60 days	60 days
To compare the occurrence of fecal impaction during a 60-day period prior to initiating Lubiprostone with a 60 day period after initiating Lubiprostone. (Quality Indicator Number 11) Tidsramme: 60 days	60 days
To compare the occurrence of fecal incontinence during a 60-day period prior to initiating Lubiprostone with a 60 day period after initiating Lubiprostone. Tidsramme: 60 days	60 days

Samarbejdspartnere og efterforskere

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

Sponsor

Synergy Health Solutions

Efterforskere

Ledende efterforsker: Malcolm R Fraser, MD, Synergy Health Solutions

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. november 2009

Primær færdiggørelse (Forventet)

1. april 2010

Studieafslutning (Forventet)

1. november 2010

Datoer for studieregistrering

Først indsendt

24. september 2009

Først indsendt, der opfyldte QC-kriterier

25. september 2009

Først opslået (Skøn)

28. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. november 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. november 2010

Sidst verificeret