Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
연구 개요
상세 설명
Inflammatory bowel disease is a chronic condition that requires maintenance medication to maintain clinical remission. During clinical remission patient can be free of symptoms for long periods of time. Inflammatory bowel disease patients have been shown to have adherence rates around 40-60%. Non-adherence in patients in clinical remission is high with rates around 60%. Non adherence in patients in clinical remission can have significant impact because it can lead to higher rates of clinical flares and increased health care cost.
This will be a single-blinded randomized controlled trial to evaluate if patients randomized to an iPphone application vs. control can increase the adherence of their maintenance medication. The trial will last three months and we hope to enroll 99 patients.
The primary outcome will be adherence measured by the medication possession ratio. The secondary objective will be to evaluate if a validated adherence questionnaire can predict adherence in patients with inflammatory bowel disease.
Having an intervention that can increase adherence can provide better care for patients. Also having a validated survey tool can accurately identify non-adherence in inflammatory bowel disease patient would be a valuable tool for patient care.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- University of Wisconsin Hospital & Clinics
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- At least 18 -65 years of age.
- Diagnosed with ulcerative colitis established by history and biopsy confirmed by gastroenterology.
- On a stable dose of mesalamine for at least two months prior to entering the study
- Have an iPhone (personal iPhone)
- Patient may receive steroid or mesalamine enemas during the study only on an as needed basis
Exclusion Criteria:
• Are on more than one medication for their inflammatory bowel disease
공부 계획
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디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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가짜 비교기: Control (Arm A)
Patients randomized to Arm A(control group) will receive an iPhone application without any of the adherence intervention turned on. The control phone application will allow patients to record their medications and how many refills they have remaining. The application will also provide patients with links about their medication. No adherence intervention will be done to these patients. |
All subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on.
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실험적: Cases (Arm B)
Patients randomized to Arm B will receive an iPhone application with the adherence intervention turned on. The study coordinator will help with the installation of the iPhone application. Participants in this group will not need to pay for the iPhone application. |
All subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Medication adherence using iPhone App
기간: 3 months
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3 months
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2차 결과 측정
결과 측정 |
기간 |
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Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ)
기간: 3 months
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3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Freddy Caldera, DO, University of Wisconsin, Madison
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .