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Promoting Medication Adherence Among Older Adults With Hypertension

15. Oktober 2020 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Interventionell

Einschreibung (Tatsächlich)

36

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70112
        • Tulane University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

55 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Übliche Pflege
Experimental: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in medication adherence (PDC)
Zeitfenster: Baseline to 6 months
Change in proportion of days covered (PDC) from baseline to 6 months
Baseline to 6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in medication adherence (MMAS-8)
Zeitfenster: Baseline to 6 months
Change in MMAS-8 score from baseline to 6 months
Baseline to 6 months
Change in medication adherence (KWood-4)
Zeitfenster: Baseline to 6 months
Change in KWood-4 score from baseline to 6 months
Baseline to 6 months
Change in medication adherence (MMAS-8)
Zeitfenster: Baseline to 3 months
Change in MMAS-8 score from baseline to 3 months
Baseline to 3 months
Change in medication adherence (KWood-4)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Baseline to 6 months
Change in systolic blood pressure from baseline to 6 months
Baseline to 6 months
Change in diastolic blood pressure
Zeitfenster: Baseline to 6 months
Change in diastolic blood pressure from baseline to 6 months
Baseline to 6 months
Change in systolic blood pressure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline to 3 months
Change in health-related quality of life score (SF-36) from baseline to 3 months
Baseline to 3 months

Andere Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Marie A Krousel-Wood, MD MSPH, Tulane University
  • Studienleiter: Erin M Peacock, PhD MPH, Tulane University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2016

Primärer Abschluss (Tatsächlich)

30. Dezember 2019

Studienabschluss (Tatsächlich)

30. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

24. Mai 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juli 2016

Zuerst gepostet (Schätzen)

27. Juli 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Oktober 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Oktober 2020

Zuletzt verifiziert

1. Oktober 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 735133

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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