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OpenTrials
Completed

NCT Number: NCT02846220

Promoting 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).

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tulane University

New Orleans, Louisiana, 70112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Overcoming Immunity to Change health coaching

Behavioral

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tulane University School of Medicine

Other

Collaborators

  • Minds at Work
  • Ohio State University

Registry information

Official study title

Overcoming Immunity to Change: A Feasibility Study of a New Method to Promote Medication Adherence Among Older Adults With Hypertension

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2016
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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