- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04426331
Vouchers to Increase Uptake of Already Free Eye Care
Providing Vouchers Redeemable for Already Free Eye Exams To Increase Uptake Among a Low-Income Minority Population: A Randomized Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21287
- Johns Hopkins Hospital - Wilmer Eye Institute
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Referred for follow-up at a Screening to Prevent Glaucoma (SToP) study screening event (overarching observational study from which trial sample was drawn). SToP participants were referred for follow-up for any of the following conditions: (1) VA worse than 20/40 in at least 1 eye despite autorefraction; (2) signs of retinal abnormalities on fundus photography; (3) uninterpretable fundus photography; (4) cup-to-disc ratio (CDR) greater than or equal to 0.9, and/or CDR between 0.7 and 0.9 with visual field defects or history of glaucoma; and (5) IOP of 23 mm Hg or greater.
Exclusion Criteria:
- SToP participants who were not referred at the time of screening but later contacted after review of fundus photography
- SToP participants who were referred for follow-up but stated at the time of counseling that they were already under the care of an eye doctor
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: No Voucher
Individuals being referred from screening events randomized to "no intervention" received the standard approach to offering free follow-up examinations (patient education, standard counseling, appointment information packet, reminder phone calls).
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Eksperymentalny: Voucher Without Value Information
In addition to receiving the standard approach above, individuals being referred from screening events randomized to "Voucher Without Value Information" received a personal voucher.
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Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital. The voucher included the patient's name, the screener's name, and an expiration date 90 days from the date of screening. These participants were told: "I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. So, with this voucher, both the exam and the glasses will be completely free." |
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Eksperymentalny: Voucher With Value Information
In addition to receiving the standard approach above, individuals being referred from screening events randomized to "Voucher With Value Information" received a personal voucher, which differed from the voucher in the second arm since it included a statement of value.
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Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital, which would normally cost $250. The voucher included the patient's name, the screener's name, an expiration date 90 days from the date of screening, and a statement about the $250 voucher value. These participants were told: "I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. These services normally cost about $250, but with this voucher, both the exam and the glasses will be completely free." |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Uptake of follow-up appointment
Ramy czasowe: Within 90 days of the date of screening
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The primary endpoint was attending a follow-up appointment, either on the initially scheduled or on a rescheduled date within 90 days of the date of screening.
Individuals who did not meet this endpoint either stated that they were not interested in follow-up at the screening event itself, cancelled or did not show for their appointments on 3 occasions, stated that they were not interested in follow-up when study staff attempted to reschedule, or did not show for an appointment and could not be reached for rescheduling after 3 attempts.
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Within 90 days of the date of screening
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Uptake of initial appointment
Ramy czasowe: Within 90 days of the date of screening
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Binary indicator for completion of the initially scheduled appointment.
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Within 90 days of the date of screening
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Seema Kacker, PhD, Johns Hopkins School of Medicine
- Główny śledczy: David S Friedman, MD PhD, Massachusetts Eye and Ear Hospital
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB00054137
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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