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Measuring Adherence to Control Hypertension (MATCH)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ian Kronish, Columbia University
ClinicalTrials.gov Identifier:
NCT01257347
First received: December 8, 2010
Last updated: February 15, 2017
Last verified: February 2017
Results First Received: July 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Hypertension
Interventions: Behavioral: Disclosure of adherence report to clinician
Device: MedSignals pillbox

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Primary care providers (the cluster units) and patients were recruited from 2010 to 2014 from 2 hospital-based primary care clinics in New York City.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
200 patients were consented for the run-in and 100 were eligible for the trial and data analysis. 24 out of 49 primary care providers recruited had patients in the trial.

Reporting Groups
  Description
Usual Care Control: Physicians Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.35 patients belonged to providers in the control group.
Electronically-Measuring Adherence Intervention: Physicians Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm 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, and will list suggested clinical actions according to adherence status. 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. 65 patients belonged to providers in the intervention group.
Usual Care Control: Patients Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
Electronically-Measuring Adherence Intervention: Patients Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.

Participant Flow:   Overall Study
    Usual Care Control: Physicians   Electronically-Measuring Adherence Intervention: Physicians   Usual Care Control: Patients   Electronically-Measuring Adherence Intervention: Patients
STARTED   12 [1]   12 [2]   35   65 
COMPLETED   12   12   35   65 
NOT COMPLETED   0   0   0   0 
[1] Median patients per provider = 3; range 1-10 (35 patients)
[2] Median patients per provider = 4; range 1-13 (65 patients)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
12 usual care clinicians had visits with 35 patients; 12 intervention clinicians has visits with 65 patients. 'Participant' in this study could mean a clinician or a patient.

Reporting Groups
  Description
Usual Care Control: Physicians Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
Electronically-measuring Adherence Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm 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, and will list suggested clinical actions according to adherence status. 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.
Usual Care Control: Patients Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
Electronically-Measuring Adherence Intervention: Patients Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
Total Total of all reporting groups

Baseline Measures
   Usual Care Control: Physicians   Electronically-measuring Adherence   Usual Care Control: Patients   Electronically-Measuring Adherence Intervention: Patients   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   35   65   124 
Age 
[Units: Years]
Mean (Standard Deviation)
 46  (11)   48  (10)   64  (9)   64  (8)   47  (11) 
Sex/Gender, Customized 
[Units: Participants]
         
Female   6   7   22   50   13 
Male   6   5   13   15   11 
Race/Ethnicity, Customized 
[Units: Participants]
         
Hispanic or Latino   3   1   28   47   4 
Not Hispanic or Latino   9   11   7   18   20 
Unknown or Not Reported   0   0   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
         
American Indian or Alaska Native   0   0   0   1   0 
Asian   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   0   1   18   25   1 
White   10   9   8   17   19 
More than one race   0   0   2   4   0 
Unknown or Not Reported   2   2   7   18   4 
Region of Enrollment 
[Units: Participants]
         
United States   12   12   35   65   124 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Visits With Appropriate Hypertension Management   [ Time Frame: 1 month clinic visit ]

2.  Secondary:   Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only   [ Time Frame: 1 month clinic visit ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ian Kronish, MD, MPH
Organization: Columbia University Medical Center
phone: 2123421335
e-mail: ik2293@columbia.edu


Publications of Results:
Other Publications:

Responsible Party: Ian Kronish, Columbia University
ClinicalTrials.gov Identifier: NCT01257347     History of Changes
Other Study ID Numbers: AAAI1720
K23HL098359 ( U.S. NIH Grant/Contract )
Study First Received: December 8, 2010
Results First Received: July 25, 2016
Last Updated: February 15, 2017