HypertensionMATCHNCT01257347
Measuring Adherence to Control Hypertension
A study testing Disclosure of adherence report to clinician and MedSignals pillbox in people with Hypertension, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Disclosure of adherence report to clinician and MedSignals pillbox
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Uncontrolled Hypertension: The Role of Medication Adherence and Clinical Inertia
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.
Read the detailed description
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
- Hypertension
- Being tested
- Disclosure of adherence report to clinician, MedSignals pillbox
- Keywords
- Medication adherence, clinical inertia, treatment intensification, quality of care
- 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.
Disclosure of adherence report to clinicianBehavioural
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 pillboxDevice
Also called electronic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Disclosure of adherence report to clinician; Device: MedSignals pillbox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This will be determined based on abstracting information from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider intensified the blood pressure regimen (added or increased dose of medications). All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record.
Measured: 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
This will be determined based on interviewing patients immediately after the 1-month visit using a standardized questionnaire. A research assistant who is blinded to group assignment will ask patients questions that assess whether clinicians counseled them about taking their blood pressure medications during that most recent visit. These questions are adapted from a validated questionnaire that assesses provider communication about blood pressure medications.
Measured: 1 month clinic visit
Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period
This will be determined by abstracting data from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider simplified the regimen by switching from a short-acting, multi-day dosing medication to a long-acting, once per day medication or switched two medication to a single combination pill. All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record.
Measured: 1 month clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ian Kronish, Columbia University
- Investigators
- Ian M Kronish, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257347
- Sponsor's protocol ID
- AAAI1720
- Other IDs
- K23HL098359
- Acronym
- MATCH
- Status last verified
- Feb 2017
- First submitted
- 8 Dec 2010
- Last updated
- 5 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24615061Kronish 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.
PubMed 24296721Alcantara 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.
PubMed 25280825Moise 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.
PubMed 25344354Gallagher 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.
PubMed 25909704Kronish 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.
PubMed 27255750
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled Hypertension: The Role of Medication Adherence and Clinical Inertia
- ClinicalTrials.gov ID
- NCT01257347
- Acronym / sponsor ID
- MATCH / AAAI1720
- Conditions
- Hypertension
- Keywords
- Medication adherence, clinical inertia, treatment intensification, quality of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Posted 5 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concealment (control) | Other | Device: MedSignals pillboxClinicians 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. |
| Disclosure (intervention) | Experimental | Behavioral: Disclosure of adherence report to clinician, Device: MedSignals pillboxDisclosure 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disclosure of adherence report to clinicianDuring 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. | Behavioural | Disclosure (intervention) |
| MedSignals pillboxAlso: electronic 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. | Device | Concealment (control), Disclosure (intervention) |
Primary outcome
Percentage of Visits With Appropriate Hypertension Management
Time frame: 1 month clinic visit
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.
3 secondary outcomes
Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only
Time frame: 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
Time frame: 1 month clinic visit
Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period
Time frame: 1 month clinic visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24615061Moise 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.
- Background: PubMed 24296721Kronish 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.
- Background: PubMed 25280825Alcantara 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.
- Background: PubMed 25344354Moise 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.
- Background: PubMed 25909704Gallagher 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.
- Results publication: PubMed 27255750Kronish 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian M Kronish, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disclosure of adherence report to clinician and MedSignals pillbox in people with Hypertension, run by Columbia University 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 5 inclusion and 5 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 5 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Visits With Appropriate Hypertension Management (time frame: 1 month clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01257347, which also lists 6 linked publications.
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 5 Apr 2017; AzTrials last refreshed its copy on 28 Oct 2026.