Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Hospital & Clinics
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Sham-komparator: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Medication adherence using iPhone App
Tidsramme: 3 months
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3 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ)
Tidsramme: 3 months
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3 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Freddy Caldera, DO, University of Wisconsin, Madison
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012 - 0726
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