Medication Adherence in Hypertension Study

NCT00688350 | Completed

• 1 other identifier: UMC1114797
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; Aging; Medication adherence; Medication compliance

Outcome Measures

Primary Outcomes (1)

• Outcome Measure: Medication adherence

  4 and 12 weeks post-intervention

Secondary Outcomes (1)

• Resting blood pressure

  4 and 12 weeks post-intervention

Study Arms (2)

Behavioral feedback

EXPERIMENTAL

Behavioral feedback intervention to improve adherence to antihypertensive medication

Behavioral: Behavioral feedback

Control

NO INTERVENTION

Control group

Interventions

Behavioral feedback BEHAVIORAL

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.

Behavioral feedback

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• The John A. Hartford Foundation: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

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

• Todd M. Ruppar, PhD, RN

  University of Missouri - Columbia Sinclair School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 4, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)