Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Promoting Medication Adherence Among Older Adults With Hypertension

15. oktober 2020 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

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
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University

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

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Sædvanlig pleje
Eksperimentel: 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
Adfærdsmæssigt: Overcoming Immunity to Change health coaching

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Tulane University School of Medicine

Samarbejdspartnere

Ohio State University
Minds at Work

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. oktober 2016

Primær færdiggørelse (Faktiske)

30. december 2019

Studieafslutning (Faktiske)

30. december 2019

Datoer for studieregistrering

Først indsendt

24. maj 2016

Først indsendt, der opfyldte QC-kriterier

22. juli 2016

Først opslået (Skøn)

27. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 735133

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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 .

Kliniske forsøg med Forhøjet blodtryk

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mauritania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner