Constipation Clinical Trial
Official title:
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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