Promoting Medication Adherence Among Older Adults With Hypertension

NCT ID: NCT02846220

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Overcoming Immunity to Change health coaching

Intervention Type: BEHAVIORAL

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Overcoming Immunity to Change health coaching

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minds at Work

UNKNOWN

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

Tulane University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Marie Krousel-Wood

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie A Krousel-Wood, MD MSPH

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Erin M Peacock, PhD MPH

Role: STUDY_DIRECTOR

Tulane University

Locations

Tulane University

New Orleans, Louisiana, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24978395 (View on PubMed)

Other Identifiers

735133

Identifier Type: -

Identifier Source: org_study_id