Promoting Medication Adherence Among Older Adults With Hypertension
15 oktober 2020 uppdaterad 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Louisiana
-
New Orleans, Louisiana, Förenta staterna, 70112
- Tulane University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
55 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Vanlig skötsel
|
|
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in medication adherence (PDC)
Tidsram: Baseline to 6 months
|
Change in proportion of days covered (PDC) from baseline to 6 months
|
Baseline to 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in medication adherence (MMAS-8)
Tidsram: Baseline to 6 months
|
Change in MMAS-8 score from baseline to 6 months
|
Baseline to 6 months
|
|
Change in medication adherence (KWood-4)
Tidsram: Baseline to 6 months
|
Change in KWood-4 score from baseline to 6 months
|
Baseline to 6 months
|
|
Change in medication adherence (MMAS-8)
Tidsram: Baseline to 3 months
|
Change in MMAS-8 score from baseline to 3 months
|
Baseline to 3 months
|
|
Change in medication adherence (KWood-4)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: Baseline to 6 months
|
Change in systolic blood pressure from baseline to 6 months
|
Baseline to 6 months
|
|
Change in diastolic blood pressure
Tidsram: Baseline to 6 months
|
Change in diastolic blood pressure from baseline to 6 months
|
Baseline to 6 months
|
|
Change in systolic blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to 3 months
|
Change in health-related quality of life score (SF-36) from baseline to 3 months
|
Baseline to 3 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in hidden motives score
Tidsram: Baseline to 6 months
|
Change in hidden motives score from baseline to 6 months
|
Baseline to 6 months
|
|
Change in hidden motives score
Tidsram: Baseline to 3 months
|
Change in hidden motives score from baseline to 3 months
|
Baseline to 3 months
|
|
Change in explicit attitudes score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline to 6 months
|
Change in score on MUSE scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in self-efficacy (MUSE)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline to 3 months
|
Change in score on SEMCD scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in chronic stress
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to 3 months
|
Change in score on 4-item version of Perceived Stress Scale from baseline to 3 months
|
Baseline to 3 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Marie A Krousel-Wood, MD MSPH, Tulane University
- Studierektor: Erin M Peacock, PhD MPH, Tulane University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 oktober 2016
Primärt slutförande (Faktisk)
30 december 2019
Avslutad studie (Faktisk)
30 december 2019
Studieregistreringsdatum
Först inskickad
24 maj 2016
Först inskickad som uppfyllde QC-kriterierna
22 juli 2016
Första postat (Uppskatta)
27 juli 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 oktober 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 oktober 2020
Senast verifierad
1 oktober 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 735133
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .