Promoting Medication Adherence Among Older Adults With Hypertension

NCT02846220 | Completed DMC

• 1 other identifier: 735133
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension

Keywords

Medication Adherence; Middle Aged 45-64; Aged 65-79; Aged, 80 and over

Outcome Measures

Primary Outcomes (1)

• Change in medication adherence (PDC)

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

  Baseline to 6 months

Secondary Outcomes (17)

• Change in medication adherence (MMAS-8)

  Baseline to 6 months

• Change in medication adherence (KWood-4)

  Baseline to 6 months

• Change in medication adherence (MMAS-8)

  Baseline to 3 months

• Change in medication adherence (KWood-4)

  Baseline to 3 months

• Change in proportion with low adherence (PDC)

  Baseline to 6 months

Other Outcomes (25)

• Change in hidden motives score

  Baseline to 6 months

• Change in hidden motives score

  Baseline to 3 months

• Change in explicit attitudes score

  Baseline to 6 months

Study Arms (2)

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

Behavioral: Overcoming Immunity to Change health coaching

Usual care

NO INTERVENTION

Interventions

Overcoming Immunity to Change health coaching BEHAVIORAL

Health coaching

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment
• Enrollment in another clinical trial

Sponsors & Collaborators

• Tulane University School of Medicine: lead
• Minds at Work: collaborator
• Ohio State University: collaborator

Study Sites (1)

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

• 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.

  PMID: 24978395 BACKGROUND

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie A Krousel-Wood, MD MSPH

  Tulane University

  PRINCIPAL INVESTIGATOR

• Erin M Peacock, PhD MPH

  Tulane University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: July 27, 2016
• Study Start: October 1, 2016
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)