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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Florida
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Brooksville、Florida、アメリカ
- Geriatric Medical Associates
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Casselberry、Florida、アメリカ
- Cassellberry Family Practice
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Melbourne、Florida、アメリカ
- Osler Geriatrics
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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Lubiprostone
Subjects switching from current bowel medicines to lubiprostone
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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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.
時間枠：60 days
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60 days
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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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)
時間枠：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)
時間枠：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.
時間枠：60 days
|
60 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Malcolm R Fraser, MD、Synergy Health Solutions
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。