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Promoting Medication Adherence Among Older Adults With Hypertension

15. oktober 2020 oppdatert av: Marie Krousel-Wood, Tulane University School of Medicine

Overcoming Immunity to Change: A Feasibility Study of a New Method to Promote Medication Adherence Among Older Adults With Hypertension

Over 70% of US adults 65 or older are diagnosed with hypertension, the leading cause of cardiovascular disease and premature deaths in the world. Despite availability of effective drugs to control blood pressure, uncontrolled blood pressure and low adherence to antihypertensive drugs persist as major public health and clinical challenges. On average, 50% of adults adhere to chronic disease medications and lower levels of adherence are associated with worse blood pressure control and adverse outcomes. Many barriers to adherence are well known and have been targeted in interventions to improve medication adherence. As of yet, no single intervention has emerged as superior or even particularly effective in improving adherence. The investigators have recently identified unconscious, self-protective 'hidden motives' that contribute to nonadherence to chronic disease medications. There is a critical need to expand on this insight to test the potential for targeting individuals' 'hidden motives' for low adherence using an innovative learning process called Immunity-to-Change.

As a critical step in testing this intervention to target these 'hidden motives', the investigators will undertake a pilot study to assess the feasibility and acceptability of the Overcoming Immunity-to-Change intervention and determine effect sizes of the intervention on adherence, blood pressure (BP) control, and quality of life (QOL). The investigators will test the Immunity-to-Change intervention in a sample of nonadherent older adults with hypertension (n=18). Another sample of nonadherent older adults with hypertension will be monitored for comparison (n=18).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

36

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
      • New Orleans, Louisiana, Forente stater, 70112
        • Tulane University

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

55 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Men and women ages 55 and older, with the goal of a sex- and race-balanced sample
  • Diagnosis of essential hypertension
  • Uncontrolled hypertension
  • Current treatment with antihypertensive medication
  • Low antihypertensive pharmacy refill
  • English speaking
  • Telephone access
  • Ability to read print on a computer screen and use the computer keyboard
  • Written consent to participate and HIPAA authorization
  • Written acceptance of study contract
  • Approval of health care provider

Exclusion Criteria:

  • Cognitive impairment
  • Enrollment in another clinical trial

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: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Vanlig omsorg
Eksperimentell: Health coaching

Two-hour in-person group counseling session led by health coach, involving development of personalized immunity maps that lay out adherence goal, behaviors that distract from goal, hidden motives that compete with achieving goal, and underlying assumptions

Eight 50-minute individual telephone counseling sessions every three weeks with a health coach, focusing on uncovering hidden motives and challenging assumptions with the goal of overturning nonadherence mindsets
Atferdsmessig: Overcoming Immunity to Change health coaching

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in medication adherence (PDC)
Tidsramme: Baseline to 6 months
Change in proportion of days covered (PDC) from baseline to 6 months
Baseline to 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in medication adherence (MMAS-8)
Tidsramme: Baseline to 6 months
Change in MMAS-8 score from baseline to 6 months
Baseline to 6 months
Change in medication adherence (KWood-4)
Tidsramme: Baseline to 6 months
Change in KWood-4 score from baseline to 6 months
Baseline to 6 months
Change in medication adherence (MMAS-8)
Tidsramme: Baseline to 3 months
Change in MMAS-8 score from baseline to 3 months
Baseline to 3 months
Change in medication adherence (KWood-4)
Tidsramme: Baseline to 3 months
Change in KWood-4 score from baseline to 3 months
Baseline to 3 months
Change in proportion with low adherence (PDC)
Tidsramme: Baseline to 6 months
Change in proportion with low adherence (PDC<0.8) from baseline to 6 months
Baseline to 6 months
Change in proportion with low adherence (MMAS-8)
Tidsramme: Baseline to 6 months
Change in proportion with low adherence (MMAS-8<6) from baseline to 6 months
Baseline to 6 months
Change in proportion with low adherence (KWood-4)
Tidsramme: Baseline to 6 months
Change in proportion with low adherence (KWood-4>0) from baseline to 6 months
Baseline to 6 months
Change in proportion with low adherence (MMAS-8)
Tidsramme: Baseline to 3 months
Change in proportion with low adherence (MMAS-8<6) from baseline to 3 months
Baseline to 3 months
Change in proportion with low adherence (KWood-4)
Tidsramme: Baseline to 3 months
Change in proportion with low adherence (KWood-4>0) from baseline to 3 months
Baseline to 3 months
Change in systolic blood pressure
Tidsramme: Baseline to 6 months
Change in systolic blood pressure from baseline to 6 months
Baseline to 6 months
Change in diastolic blood pressure
Tidsramme: Baseline to 6 months
Change in diastolic blood pressure from baseline to 6 months
Baseline to 6 months
Change in systolic blood pressure
Tidsramme: Baseline to 3 months
Change in systolic blood pressure from baseline to 3 months (if available from insurance records)
Baseline to 3 months
Change in diastolic blood pressure
Tidsramme: Baseline to 3 months
Change in diastolic blood pressure from baseline to 3 months (if available from insurance records)
Baseline to 3 months
Change in proportion with controlled blood pressure
Tidsramme: Baseline to 6 months
Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 6 months
Baseline to 6 months
Change in proportion with controlled blood pressure
Tidsramme: Baseline to 3 months
Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 3 months
Baseline to 3 months
Change in health-related quality of life
Tidsramme: Baseline to 6 months
Change in health-related quality of life score (SF-36) from baseline to 6 months
Baseline to 6 months
Change in health-related quality of life
Tidsramme: Baseline to 3 months
Change in health-related quality of life score (SF-36) from baseline to 3 months
Baseline to 3 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in hidden motives score
Tidsramme: Baseline to 6 months
Change in hidden motives score from baseline to 6 months
Baseline to 6 months
Change in hidden motives score
Tidsramme: Baseline to 3 months
Change in hidden motives score from baseline to 3 months
Baseline to 3 months
Change in explicit attitudes score
Tidsramme: Baseline to 6 months
Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 6 months
Baseline to 6 months
Change in explicit attitudes score
Tidsramme: Baseline to 3 months
Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 3 months
Baseline to 3 months
Change in implicit attitudes score
Tidsramme: Baseline to 6 months
Change in implicit attitudes score (d-score from single-category implicit association test) from baseline to 6 months
Baseline to 6 months
Change in explicit ambivalence score
Tidsramme: Baseline to 6 months
Change in explicit ambivalence score (absolute value of difference between standardized positive and negative explicit attitudes scores) from baseline to 6 months
Baseline to 6 months
Change in explicit ambivalence score
Tidsramme: Baseline to 3 months
Change in explicit ambivalence score (absolute value of difference between standardized positive and negative explicit attitudes scores) from baseline to 3 months
Baseline to 3 months
Change in implicit ambivalence score
Tidsramme: Baseline to 6 months
Change in implicit ambivalence score (absolute value of difference between standardized explicit and implicit attitude scores)
Baseline to 6 months
Change in short risk aversion switch point
Tidsramme: Baseline to 6 months
Change in short switch point on risk aversion scale from baseline to 6 months
Baseline to 6 months
Change in short risk aversion switch point
Tidsramme: Baseline to 3 months
Change in short switch point on risk aversion scale from baseline to 3 months
Baseline to 3 months
Change in long risk aversion switch point
Tidsramme: Baseline to 6 months
Change in long switch point on risk aversion scale from baseline to 6 months
Baseline to 6 months
Change in long risk aversion switch point
Tidsramme: Baseline to 3 months
Change in long switch point on risk aversion scale from baseline to 3 months
Baseline to 3 months
Change in risk valuation
Tidsramme: Baseline to 6 months
Change in value indicated on risk aversion scale from baseline to 6 months
Baseline to 6 months
Change in risk valuation
Tidsramme: Baseline to 3 months
Change in value indicated on risk aversion scale from baseline to 3 months
Baseline to 3 months
Change in medication-taking self-efficacy (MUSE)
Tidsramme: Baseline to 6 months
Change in score on MUSE medication-taking subscale from baseline to 6 months
Baseline to 6 months
Change in medication-taking self-efficacy (MUSE)
Tidsramme: Baseline to 3 months
Change in score on MUSE medication-taking subscale from baseline to 3 months
Baseline to 3 months
Change in learning-about-medications self-efficacy (MUSE)
Tidsramme: Baseline to 6 months
Change in score on MUSE learning-about-medications subscale from baseline to 6 months
Baseline to 6 months
Change in learning-about-medications self-efficacy (MUSE)
Tidsramme: Baseline to 3 months
Change in score on MUSE learning-about-medications subscale from baseline to 3 months
Baseline to 3 months
Change in self-efficacy (MUSE)
Tidsramme: Baseline to 6 months
Change in score on MUSE scale from baseline to 6 months
Baseline to 6 months
Change in self-efficacy (MUSE)
Tidsramme: Baseline to 3 months
Change in score on MUSE scale from baseline to 3 months
Baseline to 3 months
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
Tidsramme: Baseline to 6 months
Change in score on SEMCD scale from baseline to 6 months
Baseline to 6 months
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
Tidsramme: Baseline to 3 months
Change in score on SEMCD scale from baseline to 3 months
Baseline to 3 months
Change in chronic stress
Tidsramme: Baseline to 6 months
Change in chronic stress from baseline to 6 months, as measured by salivary cortisol
Baseline to 6 months
Change in perceived stress
Tidsramme: Baseline to 6 months
Change in score on 4-item version of Perceived Stress Scale from baseline to 6 months
Baseline to 6 months
Change in perceived stress
Tidsramme: Baseline to 3 months
Change in score on 4-item version of Perceived Stress Scale from baseline to 3 months
Baseline to 3 months

Samarbeidspartnere og etterforskere

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

Sponsor

Tulane University School of Medicine

Samarbeidspartnere

Ohio State University
Minds at Work

Etterforskere

  • Hovedetterforsker: Marie A Krousel-Wood, MD MSPH, Tulane University
  • Studieleder: Erin M Peacock, PhD MPH, 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)

1. oktober 2016

Primær fullføring (Faktiske)

30. desember 2019

Studiet fullført (Faktiske)

30. desember 2019

Datoer for studieregistrering

Først innsendt

24. mai 2016

Først innsendt som oppfylte QC-kriteriene

22. juli 2016

Først lagt ut (Anslag)

27. juli 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 735133

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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