Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents (STOOL)
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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Florida
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Brooksville, Florida, Vereinigte Staaten
- Geriatric Medical Associates
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Casselberry, Florida, Vereinigte Staaten
- Cassellberry Family Practice
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Melbourne, Florida, Vereinigte Staaten
- Osler Geriatrics
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Lubiprostone
Subjects switching from current bowel medicines to lubiprostone
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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To determine the overall reduction in the number of oral medicines taken by each NH resident at enrollment and at 60 days.
Zeitfenster: 60 days
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60 days
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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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)
Zeitfenster: 60 days
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60 days
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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)
Zeitfenster: 60 days
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60 days
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To compare the occurrence of fecal incontinence during a 60-day period prior to initiating Lubiprostone with a 60 day period after initiating Lubiprostone.
Zeitfenster: 60 days
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60 days
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Malcolm R Fraser, MD, Synergy Health Solutions
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STOOL
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