Measuring Adherence to Control Hypertension

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study is to test whether accurately measuring patients' adherence to their blood pressure medications with electronic pillbox monitors and then providing clinicians with this information can improve the clinical management of uncontrolled hypertension.

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Detailed Description

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Despite the presence of numerous effective medications, one-half of the adults receiving treatment for hypertension in the United States have uncontrolled blood pressure. At least one-third of these hypertensive patients are not adherent to their blood pressure medications. Given this high rate of non-adherence, clinicians will ideally consider whether their patients are taking their pills before deciding whether to intensify a blood pressure regimen. Yet, in practice, clinicians are often unsure about their patients' level of adherence. This uncertainty limits clinicians' ability to optimally manage hypertension. Electronic medication monitors represent the gold-standard for objectively measuring day-to-day adherence. As a result, they have the potential to best reduce uncertainty regarding medication adherence. The goal of this study is to test whether providing clinicians with an objective measure of medication adherence obtained through electronic monitoring can improve clinician management of uncontrolled hypertension. When data from monitoring indicate poor adherence, it may motivate clinicians to counsel their patients on adherence. Conversely, when data from monitoring indicate good adherence among patients with uncontrolled hypertension, it may motivate clinicians to intensify treatment rather than presume patients were non-adherent.

To test this hypothesis, this study will first enroll and randomize 30 primary care clinicians. Clinicians randomized to the intervention will be trained in the use of a quantitative report that summarizes their patients' adherence to blood pressure medications; they will receive these reports during visits with patients who later get enrolled in the study.

The study will then enroll 300 patients with uncontrolled hypertension from the same clinic. These patients will then have their adherence to up to 4 blood pressure medications measured by an electronic pillbox. The MedSignals® pillbox (LIFETECHniques Inc., San Antonio, TX) is small (5"x3½"x1"), easily portable, and can simultaneous monitor adherence to up to four medications. The device records a pill as taken each time the individual pillbox lid is opened and closed. Data on adherence are easily uploaded (\< 1 minute) by connecting the pillbox to a telephone line.

Patients will return to the clinic after 1 month of taking their pills from the electronic pillbox for a visit with a research assistant and their clinician. At this time, data from the pillboxes will be downloaded and used to generate an adherence report. The report will summarize the percent of days that blood pressure medications were taken as prescribed during the monitoring period and will provide guidance on how to take action based on the data. After the report is generated (\< 5 minutes), patients will attend visits with their clinicians. Clinicians in the intervention group will receive the adherence report at the time of this visit whereas clinicians in the control group will treat patients according to usual care (without report). Hypertension management during the 1-month clinic visit will be assessed after the visit by 1) reviewing the medical note to determine if clinicians intensified hypertension treatment and 2) surveying patients to determine if clinicians counseled them on adherence. Hypertension management will then be compared between groups.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Concealment (control)

Clinicians in the control arm will not receive any electronically-monitored medication adherence information (collected via MedSignals pillbox) at the 1-month visit and will be expected to manage hypertension according to their usual care.

Group Type OTHER

MedSignals pillbox

Intervention Type DEVICE

(Non-experimental) Patients will be given an electronic pillbox. The device records the date and time when each compartment is opened. Adherence to each BP medication was calculated as the percent of doses taken as prescribed. Patients are informed that their adherence was recorded by the electronic pillbox and might be shared with their clinician depending on randomization.

Disclosure (intervention)

Disclosure of adherence report to clinician:

At clinic visits with patients with uncontrolled hypertension, clinicians in the intervention arm were provided with a quantitative summary of their patients' electronic adherence to antihypertensive medications (collected via MedSignals pillbox).

Group Type EXPERIMENTAL

Disclosure of adherence report to clinician

Intervention Type BEHAVIORAL

During clinical visits with patients with uncontrolled hypertension, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. Clinicians in the intervention arm will get a brief training (\<10 minutes) in the interpretation and use of the report at the time of enrollment.

MedSignals pillbox

Intervention Type DEVICE

(Non-experimental) Patients will be given an electronic pillbox. The device records the date and time when each compartment is opened. Adherence to each BP medication was calculated as the percent of doses taken as prescribed. Patients are informed that their adherence was recorded by the electronic pillbox and might be shared with their clinician depending on randomization.

Interventions

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Disclosure of adherence report to clinician

During clinical visits with patients with uncontrolled hypertension, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. Clinicians in the intervention arm will get a brief training (\<10 minutes) in the interpretation and use of the report at the time of enrollment.

Intervention Type BEHAVIORAL

MedSignals pillbox

(Non-experimental) Patients will be given an electronic pillbox. The device records the date and time when each compartment is opened. Adherence to each BP medication was calculated as the percent of doses taken as prescribed. Patients are informed that their adherence was recorded by the electronic pillbox and might be shared with their clinician depending on randomization.

Intervention Type DEVICE

Other Intervention Names

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electronic pillbox

Eligibility Criteria

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Inclusion Criteria

* established diagnosis of hypertension
* prescribed at least one blood pressure (BP) medication
* at least two consecutive clinic visits with elevated BP according to Joint National Committee (JNC-7) guidelines (i.e., BP ≥ 140/90 mmHg or ≥ 130/80 mmHg if diabetes or chronic kidney disease)
* 18 to 80 years old
* at least one prior visit with a clinician enrolled in the study

Exclusion Criteria

* severe mental illness
* resided in a long-term care facility
* unable to use the electronic adherence device due to physical or cognitive impairment
* non-English or non-Spanish speaking
* unavailable for follow-up

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No