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Promoting Medication Adherence Among Older Adults With Hypertension

15 oktober 2020 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

36

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten, 70112
        • Tulane University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

55 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Gebruikelijke zorg
Experimenteel: 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
Gedragsmatig: Overcoming Immunity to Change health coaching

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in medication adherence (PDC)
Tijdsspanne: Baseline to 6 months
Change in proportion of days covered (PDC) from baseline to 6 months
Baseline to 6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in medication adherence (MMAS-8)
Tijdsspanne: Baseline to 6 months
Change in MMAS-8 score from baseline to 6 months
Baseline to 6 months
Change in medication adherence (KWood-4)
Tijdsspanne: Baseline to 6 months
Change in KWood-4 score from baseline to 6 months
Baseline to 6 months
Change in medication adherence (MMAS-8)
Tijdsspanne: Baseline to 3 months
Change in MMAS-8 score from baseline to 3 months
Baseline to 3 months
Change in medication adherence (KWood-4)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Baseline to 6 months
Change in systolic blood pressure from baseline to 6 months
Baseline to 6 months
Change in diastolic blood pressure
Tijdsspanne: Baseline to 6 months
Change in diastolic blood pressure from baseline to 6 months
Baseline to 6 months
Change in systolic blood pressure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline to 3 months
Change in health-related quality of life score (SF-36) from baseline to 3 months
Baseline to 3 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in hidden motives score
Tijdsspanne: Baseline to 6 months
Change in hidden motives score from baseline to 6 months
Baseline to 6 months
Change in hidden motives score
Tijdsspanne: Baseline to 3 months
Change in hidden motives score from baseline to 3 months
Baseline to 3 months
Change in explicit attitudes score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Baseline to 6 months
Change in score on MUSE scale from baseline to 6 months
Baseline to 6 months
Change in self-efficacy (MUSE)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Baseline to 3 months
Change in score on SEMCD scale from baseline to 3 months
Baseline to 3 months
Change in chronic stress
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline to 3 months
Change in score on 4-item version of Perceived Stress Scale from baseline to 3 months
Baseline to 3 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tulane University School of Medicine

Medewerkers

Ohio State University
Minds at Work

Onderzoekers

  • Hoofdonderzoeker: Marie A Krousel-Wood, MD MSPH, Tulane University
  • Studie directeur: Erin M Peacock, PhD MPH, Tulane University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 oktober 2016

Primaire voltooiing (Werkelijk)

30 december 2019

Studie voltooiing (Werkelijk)

30 december 2019

Studieregistratiedata

Eerst ingediend

24 mei 2016

Eerst ingediend dat voldeed aan de QC-criteria

22 juli 2016

Eerst geplaatst (Schatting)

27 juli 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 oktober 2020

Laatste update ingediend die voldeed aan QC-criteria

15 oktober 2020

Laatst geverifieerd

1 oktober 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 735133

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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