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Promoting Medication Adherence Among Older Adults With Hypertension

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ClinicalTrials.gov Identifier: NCT02846220
Recruitment Status : Active, not recruiting
First Posted : July 27, 2016
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Minds at Work
Ohio State University
Information provided by (Responsible Party):
Marie Krousel-Wood, Tulane University School of Medicine

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Overcoming Immunity to Change health coaching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Overcoming Immunity to Change: A Feasibility Study of a New Method to Promote Medication Adherence Among Older Adults With Hypertension
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Behavioral: Overcoming Immunity to Change health coaching
No Intervention: Usual care



Primary Outcome Measures :
  1. Change in medication adherence (PDC) [ Time Frame: Baseline to 6 months ]
    Change in proportion of days covered (PDC) from baseline to 6 months


Secondary Outcome Measures :
  1. Change in medication adherence (MMAS-8) [ Time Frame: Baseline to 6 months ]
    Change in MMAS-8 score from baseline to 6 months

  2. Change in medication adherence (KWood-4) [ Time Frame: Baseline to 6 months ]
    Change in KWood-4 score from baseline to 6 months

  3. Change in medication adherence (MMAS-8) [ Time Frame: Baseline to 3 months ]
    Change in MMAS-8 score from baseline to 3 months

  4. Change in medication adherence (KWood-4) [ Time Frame: Baseline to 3 months ]
    Change in KWood-4 score from baseline to 3 months

  5. Change in proportion with low adherence (PDC) [ Time Frame: Baseline to 6 months ]
    Change in proportion with low adherence (PDC<0.8) from baseline to 6 months

  6. Change in proportion with low adherence (MMAS-8) [ Time Frame: Baseline to 6 months ]
    Change in proportion with low adherence (MMAS-8<6) from baseline to 6 months

  7. Change in proportion with low adherence (KWood-4) [ Time Frame: Baseline to 6 months ]
    Change in proportion with low adherence (KWood-4>0) from baseline to 6 months

  8. Change in proportion with low adherence (MMAS-8) [ Time Frame: Baseline to 3 months ]
    Change in proportion with low adherence (MMAS-8<6) from baseline to 3 months

  9. Change in proportion with low adherence (KWood-4) [ Time Frame: Baseline to 3 months ]
    Change in proportion with low adherence (KWood-4>0) from baseline to 3 months

  10. Change in systolic blood pressure [ Time Frame: Baseline to 6 months ]
    Change in systolic blood pressure from baseline to 6 months

  11. Change in diastolic blood pressure [ Time Frame: Baseline to 6 months ]
    Change in diastolic blood pressure from baseline to 6 months

  12. Change in systolic blood pressure [ Time Frame: Baseline to 3 months ]
    Change in systolic blood pressure from baseline to 3 months (if available from insurance records)

  13. Change in diastolic blood pressure [ Time Frame: Baseline to 3 months ]
    Change in diastolic blood pressure from baseline to 3 months (if available from insurance records)

  14. Change in proportion with controlled blood pressure [ Time Frame: Baseline to 6 months ]
    Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 6 months

  15. Change in proportion with controlled blood pressure [ Time Frame: Baseline to 3 months ]
    Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 3 months

  16. Change in health-related quality of life [ Time Frame: Baseline to 6 months ]
    Change in health-related quality of life score (SF-36) from baseline to 6 months

  17. Change in health-related quality of life [ Time Frame: Baseline to 3 months ]
    Change in health-related quality of life score (SF-36) from baseline to 3 months


Other Outcome Measures:
  1. Change in hidden motives score [ Time Frame: Baseline to 6 months ]
    Change in hidden motives score from baseline to 6 months

  2. Change in hidden motives score [ Time Frame: Baseline to 3 months ]
    Change in hidden motives score from baseline to 3 months

  3. Change in explicit attitudes score [ Time Frame: Baseline to 6 months ]
    Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 6 months

  4. Change in explicit attitudes score [ Time Frame: Baseline to 3 months ]
    Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 3 months

  5. Change in implicit attitudes score [ Time Frame: Baseline to 6 months ]
    Change in implicit attitudes score (d-score from single-category implicit association test) from baseline to 6 months

  6. Change in explicit ambivalence score [ Time Frame: 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

  7. Change in explicit ambivalence score [ Time Frame: 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

  8. Change in implicit ambivalence score [ Time Frame: Baseline to 6 months ]
    Change in implicit ambivalence score (absolute value of difference between standardized explicit and implicit attitude scores)

  9. Change in short risk aversion switch point [ Time Frame: Baseline to 6 months ]
    Change in short switch point on risk aversion scale from baseline to 6 months

  10. Change in short risk aversion switch point [ Time Frame: Baseline to 3 months ]
    Change in short switch point on risk aversion scale from baseline to 3 months

  11. Change in long risk aversion switch point [ Time Frame: Baseline to 6 months ]
    Change in long switch point on risk aversion scale from baseline to 6 months

  12. Change in long risk aversion switch point [ Time Frame: Baseline to 3 months ]
    Change in long switch point on risk aversion scale from baseline to 3 months

  13. Change in risk valuation [ Time Frame: Baseline to 6 months ]
    Change in value indicated on risk aversion scale from baseline to 6 months

  14. Change in risk valuation [ Time Frame: Baseline to 3 months ]
    Change in value indicated on risk aversion scale from baseline to 3 months

  15. Change in medication-taking self-efficacy (MUSE) [ Time Frame: Baseline to 6 months ]
    Change in score on MUSE medication-taking subscale from baseline to 6 months

  16. Change in medication-taking self-efficacy (MUSE) [ Time Frame: Baseline to 3 months ]
    Change in score on MUSE medication-taking subscale from baseline to 3 months

  17. Change in learning-about-medications self-efficacy (MUSE) [ Time Frame: Baseline to 6 months ]
    Change in score on MUSE learning-about-medications subscale from baseline to 6 months

  18. Change in learning-about-medications self-efficacy (MUSE) [ Time Frame: Baseline to 3 months ]
    Change in score on MUSE learning-about-medications subscale from baseline to 3 months

  19. Change in self-efficacy (MUSE) [ Time Frame: Baseline to 6 months ]
    Change in score on MUSE scale from baseline to 6 months

  20. Change in self-efficacy (MUSE) [ Time Frame: Baseline to 3 months ]
    Change in score on MUSE scale from baseline to 3 months

  21. Change in self-efficacy (Self-Efficacy for Managing Chronic Disease) [ Time Frame: Baseline to 6 months ]
    Change in score on SEMCD scale from baseline to 6 months

  22. Change in self-efficacy (Self-Efficacy for Managing Chronic Disease) [ Time Frame: Baseline to 3 months ]
    Change in score on SEMCD scale from baseline to 3 months

  23. Change in chronic stress [ Time Frame: Baseline to 6 months ]
    Change in chronic stress from baseline to 6 months, as measured by salivary cortisol

  24. Change in perceived stress [ Time Frame: Baseline to 6 months ]
    Change in score on 4-item version of Perceived Stress Scale from baseline to 6 months

  25. Change in perceived stress [ Time Frame: Baseline to 3 months ]
    Change in score on 4-item version of Perceived Stress Scale from baseline to 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846220


Locations
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United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University School of Medicine
Minds at Work
Ohio State University
Investigators
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Principal Investigator: Marie A Krousel-Wood, MD MSPH Tulane University
Study Director: Erin M Peacock, PhD MPH Tulane University

Publications:
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Responsible Party: Marie Krousel-Wood, Professor, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT02846220     History of Changes
Other Study ID Numbers: 735133
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marie Krousel-Wood, Tulane University School of Medicine:
Medication Adherence
Middle Aged 45-64
Aged 65-79
Aged, 80 and over

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases