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Medikamentoverholdelsesprogram (MAP)

28. september 2026 oppdatert av: Tulane University

Støtte skreddersydd adaptiv endring og forsterkning for medisinoverholdelsesprogram: Randomisert utprøving av en ny tilnærming for å forbedre overholdelse hos eldre hypertensive kvinner og menn

Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Participants (n=402) >=40 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, Blue Cross Blue Shield of Louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. Data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

402

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70808
        • Pennington Biomedical Research Center
      • Covington, Louisiana, Forente stater, 70433
        • Tulane Doctors Dermatology & Multispecialty Clinic
      • Metairie, Louisiana, Forente stater, 70002
        • Tulane Doctors Heart & Vascular and Primary Care Clinic
      • New Orleans, Louisiana, Forente stater, 70112
        • Tulane University Clinical and Translational Unit
      • Shreveport, Louisiana, Forente stater, 71101
        • LSU Health Sciences Shreveport Clinical Trials Office

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

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • fully insured by Blue Cross Blue Shield of Louisiana (BCBSLA)
  • continuously enrolled in BCBSLA for one year
  • planning to remain a member of BCBSLA for next year
  • English-speaking
  • telephone access
  • aged ≥40 years
  • diagnosis of essential hypertension (ICD-10-CM code I10)
  • currently filling antihypertensive medication
  • low antihypertensive medication refill (proportion of days covered (PDC) <0.8)
  • low self-report adherence (4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) score ≥1)
  • uncontrolled blood pressure (BP) (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg)
  • desire to improve BP

Exclusion Criteria:

  • living in a household with someone already enrolled in the study
  • enrollment in another clinical trial for drug adherence or BP control
  • moderate to severe cognitive impairment

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: STAR-MAP

Interactive health coaching sessions and medication reminder tools
Atferdsmessig: STAR-MAP health coaching

Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior

Atferdsmessig: Medication reminder tools

Medication-taking reminder app and pillbox
Aktiv komparator: Medication App and Reminder System Medication Adherence Program (MARS-MAP)

Medication reminder tools only
Atferdsmessig: Medication reminder tools

Medication-taking reminder app and pillbox

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in proportion with PDC >=0.8 at 12 months
Tidsramme: 12 months

Proportion of days covered (PDC) calculated from pharmacy refill data
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in mean change in PDC, baseline to 12 months
Tidsramme: Baseline to 12 months

Proportion of days covered (PDC) calculated from pharmacy refill data
Baseline to 12 months
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months
Tidsramme: Baseline to 12 months

Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))
Baseline to 12 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months
Tidsramme: 12 months

Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))
12 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months
Tidsramme: Baseline to 12 months

Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications
Baseline to 12 months
Difference in proportion with controlled BP at 12 months
Tidsramme: 12 months

Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol
12 months
Difference in mean change in SBP, baseline to 12 months
Tidsramme: Baseline to 12 months

Systolic blood pressure (SBP) measured using standardized protocol
Baseline to 12 months
Difference in mean change in DBP, baseline to 12 months
Tidsramme: Baseline to 12 months

Diastolic blood pressure (DBP) measured using standardized protocol
Baseline to 12 months
Difference in mean change in health-related quality of life scores, baseline to 12 months
Tidsramme: Baseline to 12 months

Quality of life measured using 12-item Short Form Survey (SF-12); scores for eight subscales, Mental Component Summary, and Physical Component Summary calculated and compared (minimum: 0 (worse quality of life); maximum: 100 (better quality of life))
Baseline to 12 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 6 months
Tidsramme: Baseline to 6 months

Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))
Baseline to 6 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 6 months
Tidsramme: 6 months

Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))
6 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 6 months
Tidsramme: Baseline to 6 months

Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications
Baseline to 6 months
Difference in proportion with controlled BP at 6 months
Tidsramme: 6 months

Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol
6 months
Difference in mean change in SBP, baseline to 6 months
Tidsramme: Baseline to 6 months

Systolic blood pressure (SBP) measured using standardized protocol
Baseline to 6 months
Difference in mean change in DBP, baseline to 6 months
Tidsramme: Baseline to 6 months

Diastolic blood pressure (DBP) measured using standardized protocol
Baseline to 6 months
Difference in mean change in health-related quality of life scores, baseline to 6 months
Tidsramme: Baseline to 6 months

Quality of life measured using 12-item Short Form Survey (SF-12); scores for eight subscales, Mental Component Summary, and Physical Component Summary calculated and compared (minimum: 0 (worse quality of life); maximum: 100 (better quality of life))
Baseline to 6 months
Difference in proportion with PDC >=0.8 at 24 months
Tidsramme: 24 months

Proportion of days covered (PDC) calculated from pharmacy refill data
24 months
Difference in mean change in PDC, baseline to 24 months
Tidsramme: Baseline to 24 months

Proportion of days covered (PDC) calculated from pharmacy refill data
Baseline to 24 months
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 24 months
Tidsramme: Baseline to 24 months

Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))
Baseline to 24 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 24 months
Tidsramme: 24 months

Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))
24 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 24 months
Tidsramme: Baseline to 24 months

Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications
Baseline to 24 months
Difference in proportion with controlled BP at 24 months
Tidsramme: 24 months

Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol
24 months
Difference in mean change in SBP, baseline to 24 months
Tidsramme: Baseline to 24 months

Systolic blood pressure (SBP) measured using standardized protocol
Baseline to 24 months
Difference in mean change in DBP, baseline to 24 months
Tidsramme: Baseline to 24 months

Diastolic blood pressure (DBP) measured using standardized protocol
Baseline to 24 months
Difference in mean change in health-related quality of life scores, baseline to 24 months
Tidsramme: Baseline to 24 months

Quality of life measured using 12-item Short Form Survey (SF-12); scores for eight subscales, Mental Component Summary, and Physical Component Summary calculated and compared (minimum: 0 (worse quality of life); maximum: 100 (better quality of life))
Baseline to 24 months

Samarbeidspartnere og etterforskere

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

Sponsor

Tulane University

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)
Ohio State University
Minds at Work

Etterforskere

  • Hovedetterforsker: Marie A Krousel-Wood, MD, MSPH, Tulane University

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 (Faktiske)

7. mars 2022

Primær fullføring (Antatt)

30. april 2027

Studiet fullført (Antatt)

30. april 2027

Datoer for studieregistrering

Først innsendt

17. desember 2021

Først innsendt som oppfylte QC-kriteriene

17. desember 2021

Først lagt ut (Faktiske)

11. januar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2020-2221
  • R01HL153750 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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