Clinical trial NCT02846220: Promoting Medication Adherence Among Older Adults With Hypertension
Official title: Overcoming Immunity to Change: A Feasibility Study of a New Method to Promote Medication Adherence Among Older Adults With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Medication Adherence
Middle Aged 45-64
Aged 65-79
Aged, 80 and over
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Minds at Work
name: Ohio State University
First posted: 2016-07-27
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Change in medication adherence (PDC)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in medication adherence (MMAS-8)
timeFrame: Baseline to 6 months
measure: Change in medication adherence (KWood-4)
timeFrame: Baseline to 6 months
measure: Change in medication adherence (MMAS-8)
timeFrame: Baseline to 3 months
measure: Change in medication adherence (KWood-4)
timeFrame: Baseline to 3 months
measure: Change in proportion with low adherence (PDC)
timeFrame: Baseline to 6 months
measure: Change in proportion with low adherence (MMAS-8)
timeFrame: Baseline to 6 months
measure: Change in proportion with low adherence (KWood-4)
timeFrame: Baseline to 6 months
measure: Change in proportion with low adherence (MMAS-8)
timeFrame: Baseline to 3 months
measure: Change in proportion with low adherence (KWood-4)
timeFrame: Baseline to 3 months
measure: Change in systolic blood pressure
timeFrame: Baseline to 6 months
measure: Change in diastolic blood pressure
timeFrame: Baseline to 6 months
measure: Change in systolic blood pressure
timeFrame: Baseline to 3 months
measure: Change in diastolic blood pressure
timeFrame: Baseline to 3 months
measure: Change in proportion with controlled blood pressure
timeFrame: Baseline to 6 months
measure: Change in proportion with controlled blood pressure
timeFrame: Baseline to 3 months
measure: Change in health-related quality of life
timeFrame: Baseline to 6 months
measure: Change in health-related quality of life
timeFrame: Baseline to 3 months
Other outcomes:
measure: Change in hidden motives score
timeFrame: Baseline to 6 months
measure: Change in hidden motives score
timeFrame: Baseline to 3 months
measure: Change in explicit attitudes score
timeFrame: Baseline to 6 months
measure: Change in explicit attitudes score
timeFrame: Baseline to 3 months
measure: Change in implicit attitudes score
timeFrame: Baseline to 6 months
measure: Change in explicit ambivalence score
timeFrame: Baseline to 6 months
measure: Change in explicit ambivalence score
timeFrame: Baseline to 3 months
measure: Change in implicit ambivalence score
timeFrame: Baseline to 6 months
measure: Change in short risk aversion switch point
timeFrame: Baseline to 6 months
measure: Change in short risk aversion switch point
timeFrame: Baseline to 3 months
measure: Change in long risk aversion switch point
timeFrame: Baseline to 6 months
measure: Change in long risk aversion switch point
timeFrame: Baseline to 3 months
measure: Change in risk valuation
timeFrame: Baseline to 6 months
measure: Change in risk valuation
timeFrame: Baseline to 3 months
measure: Change in medication-taking self-efficacy (MUSE)
timeFrame: Baseline to 6 months
measure: Change in medication-taking self-efficacy (MUSE)
timeFrame: Baseline to 3 months
measure: Change in learning-about-medications self-efficacy (MUSE)
timeFrame: Baseline to 6 months
measure: Change in learning-about-medications self-efficacy (MUSE)
timeFrame: Baseline to 3 months
measure: Change in self-efficacy (MUSE)
timeFrame: Baseline to 6 months
measure: Change in self-efficacy (MUSE)
timeFrame: Baseline to 3 months
measure: Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
timeFrame: Baseline to 6 months
measure: Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
timeFrame: Baseline to 3 months
measure: Change in chronic stress
timeFrame: Baseline to 6 months
measure: Change in perceived stress
timeFrame: Baseline to 6 months
measure: Change in perceived stress
timeFrame: Baseline to 3 months
Locations:
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
affiliation: Tulane University
name: Marie A Krousel-Wood, MD MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University
name: Erin M Peacock, PhD MPH
role: STUDY_DIRECTOR
References:
citation: 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.