Promoting Medication Adherence Among Older Adults With Hypertension

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).

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Overcoming Immunity to Change health coaching

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tulane University School of Medicine
• Collaborators: Ohio State University; Minds at Work
• Investigators: Principal Investigator: Marie A Krousel-Wood, MD MSPH, Tulane University; Study Director: Erin M Peacock, PhD MPH, Tulane University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Medication Adherence; Aged, 80 and over; Middle Aged 45-64; Aged 65-79
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 735133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No