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Promoting Medication Adherence Among Older Adults With Hypertension

Not Applicable
Completed
Conditions
Hypertension
Interventions
Behavioral: Overcoming Immunity to Change health coaching
Registration Number
NCT02846220
Lead Sponsor
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Health coachingOvercoming Immunity to Change health coachingTwo-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
Primary Outcome Measures
NameTimeMethod
Change in medication adherence (PDC)Baseline to 6 months

Change in proportion of days covered (PDC) from baseline to 6 months

Secondary Outcome Measures
NameTimeMethod
Change in medication adherence (MMAS-8)Baseline to 3 months

Change in MMAS-8 score from baseline to 3 months

Change in proportion with low adherence (PDC)Baseline to 6 months

Change in proportion with low adherence (PDC\<0.8) from baseline to 6 months

Change in proportion with low adherence (MMAS-8)Baseline to 3 months

Change in proportion with low adherence (MMAS-8\<6) from baseline to 3 months

Change in proportion with low adherence (KWood-4)Baseline to 3 months

Change in proportion with low adherence (KWood-4\>0) from baseline to 3 months

Change in systolic blood pressureBaseline to 3 months

Change in systolic blood pressure from baseline to 3 months (if available from insurance records)

Change in diastolic blood pressureBaseline to 3 months

Change in diastolic blood pressure from baseline to 3 months (if available from insurance records)

Change in proportion with controlled blood pressureBaseline to 3 months

Change in proportion with controlled blood pressure (SBP\<140 \& DBP\<90) from baseline to 3 months

Change in health-related quality of lifeBaseline to 3 months

Change in health-related quality of life score (SF-36) from baseline to 3 months

Change in medication adherence (KWood-4)Baseline to 3 months

Change in KWood-4 score from baseline to 3 months

Trial Locations

Locations (1)

Tulane University

🇺🇸

New Orleans, Louisiana, United States

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