Measuring Adherence to Control Hypertension

NCT01257347 | Completed Results DMC

• 2 other identifiers: AAAI1720K23HL098359
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Medication adherence; clinical inertia; treatment intensification; quality of care

Outcome Measures

Primary Outcomes (1)

• Percentage of Visits With Appropriate Hypertension Management

  This is assessed using an algorithm in which patients are categorized as adherent or non-adherent based on electronic monitoring. If patients are adherent (summary measure of adherence to blood pressure medications in the week prior to visit is ≥ 80%), then hypertension management is appropriate if clinicians intensify the hypertension regimen or order testing for secondary hypertension. If patients are non-adherent (summary measure of adherence \< 80%), then hypertension management is appropriate if clinicians take action to increase adherence through counseling or regimen simplification.

  1 month clinic visit

Secondary Outcomes (3)

• Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only

  1 month clinic visit

• Percentage of Visits With Counseling Performed During 1-month Visit, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period

  1 month clinic visit

• Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period

  1 month clinic visit

Study Arms (2)

Concealment (control)

OTHER

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.

Device: MedSignals pillbox

Disclosure (intervention)

EXPERIMENTAL

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).

Behavioral: Disclosure of adherence report to clinician; Device: MedSignals pillbox

Interventions

Disclosure of adherence report to clinician 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.

Disclosure (intervention)

MedSignals pillbox 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.

Also known as: electronic pillbox

Concealment (control); Disclosure (intervention)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• to 80 years old
• at least one prior visit with a clinician enrolled in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (6)

• Moise N, Davidson KW, Chaplin W, Shea S, Kronish I. Depression and clinical inertia in patients with uncontrolled hypertension. JAMA Intern Med. 2014 May;174(5):818-9. doi: 10.1001/jamainternmed.2014.115. No abstract available.

  PMID: 24615061 BACKGROUND

• Kronish IM, Lin JJ, Cohen BE, Voils CI, Edmondson D. Posttraumatic stress disorder and medication nonadherence in patients with uncontrolled hypertension. JAMA Intern Med. 2014 Mar;174(3):468-70. doi: 10.1001/jamainternmed.2013.12881. No abstract available.

  PMID: 24296721 BACKGROUND

• Alcantara C, Edmondson D, Moise N, Oyola D, Hiti D, Kronish IM. Anxiety sensitivity and medication nonadherence in patients with uncontrolled hypertension. J Psychosom Res. 2014 Oct;77(4):283-6. doi: 10.1016/j.jpsychores.2014.07.009. Epub 2014 Jul 15.

  PMID: 25280825 BACKGROUND

• Moise N, Schwartz J, Bring R, Shimbo D, Kronish IM. Antihypertensive drug class and adherence: an electronic monitoring study. Am J Hypertens. 2015 Jun;28(6):717-21. doi: 10.1093/ajh/hpu199. Epub 2014 Oct 24.

  PMID: 25344354 BACKGROUND

• Gallagher BD, Muntner P, Moise N, Lin JJ, Kronish IM. Are two commonly used self-report questionnaires useful for identifying antihypertensive medication nonadherence? J Hypertens. 2015 May;33(5):1108-13. doi: 10.1097/HJH.0000000000000503.

  PMID: 25909704 BACKGROUND

• Kronish IM, Moise N, McGinn T, Quan Y, Chaplin W, Gallagher BD, Davidson KW. An Electronic Adherence Measurement Intervention to Reduce Clinical Inertia in the Treatment of Uncontrolled Hypertension: The MATCH Cluster Randomized Clinical Trial. J Gen Intern Med. 2016 Nov;31(11):1294-1300. doi: 10.1007/s11606-016-3757-4. Epub 2016 Jun 2.

  PMID: 27255750 RESULT

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

Results Point of Contact

• Title: Ian Kronish, MD, MPH
• Organization: Columbia University Medical Center

ik2293@columbia.edu

2123421335

Study Officials

• Ian M Kronish, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: January 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 5, 2017
• Results First Posted: April 5, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)