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Improving Adherence to Statins Among Minority Populations

21. januar 2016 opdateret af: Ana M. Palacio, University of Miami

Improving Adherence to Cholesterol Lowering Medications Among Minority Populations in Florida: A Randomized Trial

Statins are cholesterol lowering medications that reduce the risk of cardiovascular events. However adherence to these medications has been found to be lower among minorities, a group particularly vulnerable for heart disease.

The purpose of this study is to compare the efficacy of a phone based behavioral intervention to mailed educational materials regarding how to control cholesterol and other risk factors. We hypothesized that the behavioral intervention will improve adherence to statins by 15%.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cardiovascular disease (CVD) disproportionately affects members of certain racial/ethnic minority groups.Further in spite of a reduction in rates of cardiovascular events,the gap between certain minority groups and non-minority groups has not diminished. Cholesterol lowering medications are a medically proven intervention that dramatically reduces the risk of primary and secondary cardiovascular outcomes.However, the literature shows that at one year only half of the patients prescribed this medication continue to take a statin. One well known risk factor shown to be a predictor for non adherence is belonging to a racial/ ethnic minority group.

The focus of the proposed study is to examine a non-traditional care-management approach delivered by a large commercial health benefit carrier in the prevention of cardiovascular disease among minority populations who have cardiovascular risk factors and who have been started in cholesterol lowering therapy. In particular, we seek to determine if a culturally tailored phone based intervention (Motivational Interviewing) delivered to Latino and African American enrollees living in predominantly minority neighborhoods in Florida, is effective at improving adherence to Statins.

Specific Aims

  1. To prospectively identify 1200 Latino or African American residing in Florida who have received a new prescription for statin therapy, evaluate their adherence to the statin and determine if the reasons for non-adherence are similar or different from other studies of adherence to cardiovascular medications.
  2. Conduct a randomized control trial to compare the effectiveness of a motivational interviewing telephonic intervention to usual care on the primary outcome of statin adherence among minority subjects living in Florida.

In addition, among the tobacco users at baseline we will evaluate the impact of our phone based MINT intervention on tobacco cessation in this minority populations.

Update: The sponsor and the IRB approved a reduction in the target number of participants to 800. The reason was that we experienced a recruitment delay to ensure HIPAA compliant procedures between the University and the Health Benefits company when the Humana research group moved out of the University campus. Data that became available from another study showed 800 subjects will yield enough power for the analyses planned originally.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

779

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Adult patients over age 35 years
  2. Recent new prescription for a Statin (GPI code 39.40.xx ) which will be the index prescription. We will define new as no GPI code present for any statin over a 6 month period before the index prescription.
  3. Self report of being Latino or AA.

Exclusion Criteria:

  • Enrollment in any other CVD intervention program

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Usual care
Subjects randomized to usual care will receive a brochure once a year on the importance and impact of controlling cardiovascular risk factors, tips to improve statin adherence and smoking cessation strategies and public services. Subjects will also receive a letter every 6 months to remind about study participation along with educational material.
Andet: Usual Care
We selected American Heart Association brochures on a variety of risk factors, including dyslipidemia and mailed them to subjects in the usual care.
Eksperimentel: Motivational Interviewing (MINT)

The MINT intervention will consist of 6 to 9 telephone encounters between a counselor trained in Motivational interviewing. All subjects in the MINT arm will be contacted every 3 months; however subjects who are not filling medication appropriately will receive additional calls.

Each telephone encounter will last from 20 to 30 minutes and have a patient centered approach having the following basic structure and goals:

  • Establishing a connection and reinforcing autonomy: .
  • Empathizing with ambivalence and rolling with resistance.
  • Coach the subject towards expressions of commitment.
Adfærdsmæssigt: Motivational Interviewing (MINT)

MINT has the following basic structure and goals:

  • Establishing a connection and reinforcing autonomy: open ended questions regarding the health status or well being of the participant to establish an empathetic connection with the subject via reflective listening.
  • Empathizing with ambivalence and rolling with resistance. The counselor will help the subject express the ambivalence they may have regarding taking their statins.
  • Coach the subject towards expressions of commitment. Commitment is predictive of change. Speaking commitment out loud to an "other" enhances the likelihood that the commitment will be acted upon

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication possession ratio (MPR)
Tidsramme: 12 months after the statin prescription
The primary outcome will be MPR for statin medication equal or above .80. MPR is a continuous multiple interval measure of medication availability. The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the enrollment and the last day of follow up. The binary dependent variable is: MPR equal to or above .80 (adequate adherence or drug availability during 80% or more of the therapy time) and MPR below .80 (non adherence or drug availability during less than 80% of the therapy time).
12 months after the statin prescription

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Self-reported adherence score (Morisky Medication Adherence Scale-8)
Tidsramme: At baseline and 12 months after statin prescription
8-item questionaire to measure self reported adherence to statin
At baseline and 12 months after statin prescription

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Smoking status
Tidsramme: At baseline and at 12 months
Smoking history questionaire
At baseline and at 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Miami

Samarbejdspartnere

Humana Inc.

Efterforskere

  • Ledende efterforsker: Ana Palacio, University of Miami

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2010

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

14. januar 2014

Først indsendt, der opfyldte QC-kriterier

14. januar 2014

Først opslået (Skøn)

16. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1KG11
  • 4KB13 (Andet bevillings-/finansieringsnummer: James and Esther King BIomedical Research Program)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The IRB application did not include the use of the data for future research

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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