Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Study on Incentives for Glaucoma Medications Adherence (SIGMA)

28. april 2017 oppdatert av: Marcel Bilger, Duke-NUS Graduate Medical School

A Randomized Controlled Trial to Increase Glaucoma Medication Adherence Using Value Pricing

Glaucoma topical eye medications, when adhered to, are effective at controlling disease progression. Yet evidence shows that many glaucoma patients have incomplete adherence to medications, with disease progression resulting in significant costs to the patient and health system. Through the approach of value pricing, a link can be made between non-adherence and its resulting costs by granting subsidies to adherent patients for their medications and physician visits. This 6-month randomized controlled trial among 100 glaucoma patients from the Singapore National Eye Centre aims to test the extent to which value pricing can improve medication adherence.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

By reducing intraocular pressure, glaucoma topical eye medications are effective at controlling disease progression for the majority of patients. Yet evidence shows that many glaucoma patients have incomplete adherence to medications, resulting in significant personal costs in terms of disease progression and visual field loss. The cost to the health system from poor adherence is also substantial as glaucoma surgery is more costly than treatment with topical medication. Behavioural economics theory suggests that adherence rates can be improved by providing a clearer link between non-adherence and the resulting costs thereof. In the proposed study, this link is made by granting subsidies to adherent patients for their medications and physician visits, whereas those who are not sufficiently adherent would not receive the subsidy and thus pay a higher rate for their treatment.

These subsidies provide a financial incentive for patients to take their medicines as prescribed, and because prescription refills and visits occur regularly, also provide a tangible and near-term cost resulting from non-adherence. The investigators refer to this approach as value pricing as subsidies are allocated to medications that have not only been shown to be clinically effective but that are also effectively used by the patient. In efforts to increase adherence among glaucoma patients in Singapore, the investigators propose to conduct a 6-month proof-of-concept randomized controlled trial among 100 participants from the Singapore National Eye Centre (SNEC) to test the extent to which value pricing can improve medication adherence. As Singapore's population continues to age and a larger share of the population requires daily medications to treat chronic diseases, such innovative solutions are needed to ensure not only that patients take their medications as prescribed and receive the full benefit of their treatment but also that Government subsidies are allocated effectively so that to ensure the sustainability of the health system.

Specific Aim and hypothesis tested:

Aim: Test whether adding Value Pricing (VP) to Usual Care (UC) can improve medication adherence over a 6-month period.

Hypothesis: VP patients will show greater adherence rates at 6 months compared to those receiving only UC.

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Singapore
      • Singapore, Singapore
        • Singapore National Eye Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Singaporean citizens or permanent residents
  • Conversant in English or Mandarin
  • Taking at least one glaucoma eye drop medication
  • Shown to be non-adherent based on a value of 6 or less on the Modified Medication Adherence Scale (MMAS)

Exclusion Criteria:

  • Significant comorbid conditions preventing application of medications without assistance
  • Stage 4 (advanced) or Stage 5 (end stage) glaucoma according to the Glaucoma Staging System

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Usual Care (UC)

Patients receiving Usual Care for Glaucoma comprising:

  • Education on effective glaucoma treatment
  • Routine check-ups with an ophthalmologist and prescription of glaucoma eye drops

  • Glaucoma counselling [Can be recommended by ophthalmologist for non-adherent patients] covering:

    • Glaucoma risk factors and symptoms
    • Management and treatment
    • Medications and optimal dosage windows
    • Risks of medication non-adherence
    • Formulation of a dosing schedule that compliments each patient's lifestyle
Eksperimentell: Value Pricing (VP)
Patient receiving Usual Care for Glaucoma and given the opportunity to receive Value Pricing Subsidies.
Atferdsmessig: Value Pricing Subsidies
  • Usual care for glaucoma
  • Subsidies granted to adherent patients for their glaucoma medications and physician visits, lowering the costs of treatment and providing a financial incentive for patients to take their medicines as prescribed.
  • Subsidy (25 / 50%) granted based on meeting dose-rate adherence percentage targets (75 / 90%) at the month 3 and 6 assessment points.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Monthly dose-rate adherence percentage
Tidsramme: Month 6
The proportion of days across a month where a patient took all medication(s) within the appropriate dosing windows (morning, afternoon, evening) for the day.
Month 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dose-rate adherence percentage
Tidsramme: Months 1 - 6
The proportion of days across the study period where a patient took all medication(s) within the appropriate dosing windows (morning, afternoon, evening) for the day.
Months 1 - 6
Proportion meeting 90% dose-rate adherence percentage
Tidsramme: Months 3 & 6
The proportion of participants at each time point who met the 90% dose-rate adherence percentage cut-off for each monitoring period.
Months 3 & 6
Proportion meeting 75% dose-rate adherence percentage
Tidsramme: Months 3 & 6
The percentage of participants at each time point who met the 75% dose-rate adherence percentage cut-off for each monitoring period.
Months 3 & 6
Intraocular Pressure
Tidsramme: Baseline & Month 6
Intraocular Pressure measured using established protocols at SNEC.
Baseline & Month 6
EQ-5D-5L
Tidsramme: Baseline & Month 6
Scale to assess health related quality of life.
Baseline & Month 6
Glaucoma Quality of Life (GQL-15)
Tidsramme: Baseline & Month 6
Scale to measure quality of life, pertaining specifically to aspects of QoL that can be affected by the glaucoma condition.
Baseline & Month 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Duke-NUS Graduate Medical School

Samarbeidspartnere

Singapore National Eye Centre

Etterforskere

  • Hovedetterforsker: Marcel Bilger, PhD, Duke-NUS Graduate Medical School

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2014

Primær fullføring (Faktiske)

1. januar 2017

Studiet fullført (Faktiske)

1. februar 2017

Datoer for studieregistrering

Først innsendt

19. oktober 2014

Først innsendt som oppfylte QC-kriteriene

21. oktober 2014

Først lagt ut (Anslag)

22. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HSRNIG12nov007

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere