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HypertensionNCT00688350

Medication Adherence in Hypertension Study

A study testing Behavioral feedback in people with Hypertension, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hypertension
What is being tested?
Behavioral feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Jul 2008to Jun 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Missouri

    Columbia, Missouri, 65211

Other trials in United States

About this study

Official title: Interventions to Improve Medication-Taking Behavior in Older Adults With Hypertension: An Exploratory Study

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.

Read the 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.

Conditions
Hypertension
Being tested
Behavioral feedback
Keywords
Hypertension, Aging, Medication adherence, Medication compliance
Medical subject headings
Hypertension, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral feedbackBehavioural

    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.

Study groups in NCT00688350
Study groupRoleWhat they receive
Behavioral feedbackExperimentalBehavioral feedback intervention to improve adherence to antihypertensive medication
Receives: Behavioral: Behavioral feedback
ControlNo interventionControl group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Outcome Measure: Medication adherence

    Measured: 4 and 12 weeks post-intervention

Secondary outcomes (1)
  1. Resting blood pressure

    Measured: 4 and 12 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionApr 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00688350
Sponsor's protocol ID
UMC1114797
Status last verified
Oct 2016
First submitted
28 May 2008
Last updated
4 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral feedback in people with Hypertension, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Outcome Measure: Medication adherence (time frame: 4 and 12 weeks post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.

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Medication Adherence in Hypertension Study | AzTrials