Medication Adherence in Hypertension Study

This study has been completed.
Sponsor:
Collaborator:
The John A. Hartford Foundation
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00688350
First received: May 28, 2008
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

The purpose of this study is to test an intervention to help older adults do a better job of following blood pressure medication regimens prescribed by their health care providers.


Condition Intervention
Hypertension
Behavioral: Feedback-based behavioral medication adherence intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interventions to Improve Medication-Taking Behavior in Older Adults With Hypertension: An Exploratory Study

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Outcome Measure: Medication adherence [ Time Frame: 4 and 12 weeks post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resting blood pressure [ Time Frame: 4 and 12 weeks post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Feedback-based behavioral medication adherence intervention
    The medication adherence intervention consists of five components: medication feedback, hypertension feedback, medication-taking skills, habit adjustment, and succinct medication and disease information delivered over an 8-week period.
Detailed Description:

Hypertension is present in 26.7% of the U.S. adult population between ages 20 to 74 (National Center for Health Statistics, 2006). The prevalence increases with age. Sixty-seven percent of adults aged 60 years or older have hypertension, a rise from 58% just ten years earlier (Ostchega, Dillon, Hughes, Carroll, & Yoon, 2007). Uncontrolled hypertension increases the risk for heart attack, stroke, congestive heart failure, and kidney disease (Chobanian et al., 2003; Stamler, Stamler, & Neaton, 1993; Vasan et al., 2001). Maintaining a normal blood pressure has been shown to be associated with a greater probability of living to age 85, and of living to age 85 without major health concerns (Terry et al., 2005). The most common treatment for managing hypertension involves the use of antihypertensive medications. These medications have been shown to effectively lower blood pressure (BP) and prevent the development of serious sequelae (Chobanian et al., 2003). Unfortunately, failure to adhere to antihypertensive medication regimens can impede the effectiveness of therapy.

Studies have reported levels of medication adherence among the elderly ranging from 26% to 59% (Botelho & Dudrak, 1992; van Eijken, Tsang, Wensing, de Smet, & Grol, 2003). Adherence to a medication regimen requires a set of behaviors that include obtaining the medication; timely administration of the correct drug, dose, and route; and persisting with taking the medication as long as the medication is needed. Success at these behaviors can be hampered by many of the changes often seen with age. Sensory loss, disturbances in memory and cognition, depression, and lifestyle changes such as retirement can disrupt routines or affect skills previously used to maintain medication adherence (Brown et al., 2005; Conn, Taylor, & Miller, 1994; Coons et al., 1994; Gehi, Haas, Pipkin, & Whooley, 2005; Schlenk, Dunbar-Jacob, & Engberg, 2004; Vik, Maxwell, & Hogan, 2004). Effective community-based interventions are needed to equip health care providers with tools to improve antihypertensive medication regimen adherence among their older patients. Many interventions have been tested to improve medication adherence in hypertension, but few addressing the unique needs of older adults. Of those that have been tested, there has been great variation in outcomes and ability to translate interventions into clinical practice.

This exploratory randomized controlled trial will test an 8-week behavioral intervention to improve medication adherence in older adults with hypertension.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be aged 60 years or greater at time of study entry.
  • Participants must be able to read, write, and converse in English.
  • Participants will have a diagnosis of hypertension (based on participant report).
  • Participants will have an active prescription for at least one antihypertensive medication with no antihypertensive prescription changes for 30 days at the time of study entry.
  • Participants must self-administer his or her own medications without prompts from any other person or device.
  • Baseline medication adherence rate of < 85%.
  • Participants must be free of cognitive deficit as determined by a score of "normal" (0 - 2) on the Short Portable Mental Status Questionnaire (SPMSQ).
  • Participants agree to complete all study contacts and measurements, including the use a special medication bottle with a Medication Event Monitoring System (MEMS) cap for the duration of the study.
  • Able to open and close MEMS caps.

Exclusion Criteria:

  • Participant is in state of severe hypertension (BP of >180/120 mmHg) at the time of study enrollment. Participants presenting with severely elevated blood pressure will be referred to their primary care provider.
  • Participant resides in a residential facility where medications are administered by facility staff. Participants who reside in assisted living facilities but maintain control of their medications remain eligible.
  • Participant has a terminal chronic illness with a life expectancy of six months or less.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688350

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Missouri-Columbia
The John A. Hartford Foundation
Investigators
Principal Investigator: Todd M. Ruppar, PhD, RN University of Missouri - Columbia Sinclair School of Nursing
  More Information

No publications provided

Responsible Party: Todd Ruppar, PhD, RN, GCNS-BC, University of Missouri Sinclair School of Nursing
ClinicalTrials.gov Identifier: NCT00688350     History of Changes
Other Study ID Numbers: UMC1114797
Study First Received: May 28, 2008
Last Updated: August 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Hypertension
Aging
Medication adherence
Medication compliance

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014