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| Name | Class |
|---|---|
| Minds at Work | UNKNOWN |
| Ohio State University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health coaching | Experimental | 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 |
|
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overcoming Immunity to Change health coaching | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in medication adherence (PDC) | Change in proportion of days covered (PDC) from baseline to 6 months | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in medication adherence (MMAS-8) | Change in MMAS-8 score from baseline to 6 months | Baseline to 6 months |
| Change in medication adherence (KWood-4) | Change in KWood-4 score from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hidden motives score | Change in hidden motives score from baseline to 6 months | Baseline to 6 months |
| Change in hidden motives score | Change in hidden motives score from baseline to 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie A Krousel-Wood, MD MSPH | Tulane University | Principal Investigator |
| Erin M Peacock, PhD MPH | Tulane University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24978395 | Background | Krousel-Wood M, Kegan R, Whelton PK, Lahey LL. Immunity-to-change: are hidden motives underlying patient nonadherence to chronic disease medications? Am J Med Sci. 2014 Aug;348(2):121-8. doi: 10.1097/MAJ.0000000000000310. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| Baseline to 6 months |
| Change in medication adherence (MMAS-8) | Change in MMAS-8 score from baseline to 3 months | Baseline to 3 months |
| Change in medication adherence (KWood-4) | Change in KWood-4 score from baseline to 3 months | Baseline to 3 months |
| Change in proportion with low adherence (PDC) | 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) | 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) | 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) | 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) | Change in proportion with low adherence (KWood-4>0) from baseline to 3 months | Baseline to 3 months |
| Change in systolic blood pressure | Change in systolic blood pressure from baseline to 6 months | Baseline to 6 months |
| Change in diastolic blood pressure | Change in diastolic blood pressure from baseline to 6 months | Baseline to 6 months |
| Change in systolic blood pressure | Change in systolic blood pressure from baseline to 3 months (if available from insurance records) | Baseline to 3 months |
| Change in diastolic blood pressure | 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 | 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 | 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 | 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 | Change in health-related quality of life score (SF-36) from baseline to 3 months | Baseline to 3 months |
| Baseline to 3 months |
| Change in explicit attitudes score | Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 6 months | Baseline to 6 months |
| Change in explicit attitudes score | Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 3 months | Baseline to 3 months |
| Change in implicit attitudes score | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Change in long switch point on risk aversion scale from baseline to 3 months | Baseline to 3 months |
| Change in risk valuation | Change in value indicated on risk aversion scale from baseline to 6 months | Baseline to 6 months |
| Change in risk valuation | Change in value indicated on risk aversion scale from baseline to 3 months | Baseline to 3 months |
| Change in medication-taking self-efficacy (MUSE) | Change in score on MUSE medication-taking subscale from baseline to 6 months | Baseline to 6 months |
| Change in medication-taking self-efficacy (MUSE) | 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) | 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) | Change in score on MUSE learning-about-medications subscale from baseline to 3 months | Baseline to 3 months |
| Change in self-efficacy (MUSE) | Change in score on MUSE scale from baseline to 6 months | Baseline to 6 months |
| Change in self-efficacy (MUSE) | 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) | 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) | Change in score on SEMCD scale from baseline to 3 months | Baseline to 3 months |
| Change in chronic stress | Change in chronic stress from baseline to 6 months, as measured by salivary cortisol | Baseline to 6 months |
| Change in perceived stress | Change in score on 4-item version of Perceived Stress Scale from baseline to 6 months | Baseline to 6 months |
| Change in perceived stress | Change in score on 4-item version of Perceived Stress Scale from baseline to 3 months | Baseline to 3 months |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |