Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
Studieoversikt
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin Hospital & Clinics
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Eksperimentell: 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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Hva måler studien?
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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Freddy Caldera, DO, University of Wisconsin, Madison
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2012 - 0726
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