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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Florida
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Brooksville, Florida, Stati Uniti
- Geriatric Medical Associates
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Casselberry, Florida, Stati Uniti
- Cassellberry Family Practice
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Melbourne, Florida, Stati Uniti
- Osler Geriatrics
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Lubiprostone
Subjects switching from current bowel medicines to lubiprostone
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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.
Lasso di tempo: 60 days
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60 days
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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)
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: 60 days
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60 days
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Malcolm R Fraser, MD, Synergy Health Solutions
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STOOL
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