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Financial Incentives for Medication Adherence (FIMA)

30. januar 2015 oppdatert av: Boston Medical Center

This study is a pilot study. The investigators have designed a randomized, controlled trial of financial incentives in medication adherence, focusing primarily on poorly-controlled diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that many patients do not take their medications as prescribed by their doctors. This contributes to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and death. The investigators hypothesize that use of a financial incentive will motivate patients to improve their medication adherence and ultimately their control of their chronic diseases.

The investigators plan to identify patients who get Primary Care at Boston Medical Center who still have high blood sugars more than a year after their diabetes diagnosis, and randomize them to a control arm, or one of two intervention arms. Subjects will be approached at the time of a regularly-scheduled appointment with their Primary Care doctor and offered the opportunity to participate in the study. All subjects who agree to participate in the study will meet with a Clinical Pharmacologist to review their medications in detail, and then undergo randomization. Subjects in the first intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month. Subjects in the second intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month, and a one-time payment at the conclusion of the study based on the amount of hemoglobin A1c decrease. The investigators will enroll a total of 100 subjects in the study, and anticipate an observational cohort of approximately 1,000 patients.

All patients who are eligible for the study but who are not enrolled in the study and have not declined to participate in the study will become the observational cohort for the study. The observational cohort will be used to determine whether randomization to the control arm of the study has a negative, rather than neutral, effect on patients.

At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to have their blood pressure checked and to have their blood drawn so that their blood sugar and cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid panel, systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and macrovascular complications, and death.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

74

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Boston Medical 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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Speaks English, Spanish, or Haitian Creole
  • Established patient in Boston Medical Center Section of General Internal Medicine Primary Care Practice
  • Uses Boston Medical Center Pharmacy
  • Diagnosed with diabetes for more than one year
  • Prescribed medications for diabetes
  • Last hemoglobin A1c > 7.9

Exclusion Criteria:

  • Pregnant
  • History of Brittle Diabetes
  • Meets April, 2012 American Diabetes Association criteria for an increased goal hemoglobin A1c

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Monthly Incentive
Subjects in this arm will receive a cash incentive each month when they pick up their medications for diabetes, hypertension, and hypercholesterolemia at the pharmacy on time. The intervention is the cash incentive.
A cash payment.
Eksperimentell: Monthly and Final Incentive
Subjects in this arm will receive a cash incentive each month when they pick up their medications for diabetes, hypertension and hypercholesterolemia at the pharmacy on time, as well as an additional financial incentive for each full percentage point of decrease in their hemoglobin A1c over the eight-month course of the study. The two cash incentives are the intervention.
A cash payment.
One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.
Ingen inngripen: Control
These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Improvement in hemoglobin A1c
Tidsramme: 8 months
The investigators will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.
8 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Improvement in blood pressure.
Tidsramme: Eight months
The investigators will assess blood pressure measurements at the start and end of the study.
Eight months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lipid levels
Tidsramme: Eight months
The investigators will assess lipid levels at the start and end of the study.
Eight months

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Elizabeth Rourke, MD, Boston Medical Center
  • Hovedetterforsker: Amitabh Chandra, Ph.D., Harvard Kennedy School, National Bureau of Economic Research
  • Hovedetterforsker: Katherine Baicker, Ph.D., Harvard School of Public Health, National Bureau of Economic Research

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. september 2012

Primær fullføring (Faktiske)

1. april 2014

Studiet fullført (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først innsendt

30. august 2012

Først innsendt som oppfylte QC-kriteriene

31. august 2012

Først lagt ut (Anslag)

3. september 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. februar 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. januar 2015

Sist bekreftet

1. januar 2015

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • BU IRB H-30045
  • WS2069417 (Annet stipend/finansieringsnummer: Pfizer)

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. .

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