N/A N=124 Randomized Double-blind Prevention

Measuring Adherence to Control Hypertension

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01257347 ↗

Enrolled (actual)

124

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Percentage of Visits With Appropriate Hypertension Management — 34; 69 percentage of patient-clinician visits — p=<=0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Disclosure of adherence report to clinician (Behavioral); MedSignals pillbox (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Visits With Appropriate Hypertension Management	34; 69	<=0.001 sig
SECONDARY Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only	26; 56	—
SECONDARY Percentage of Visits With Counseling Performed During 1-month Visit, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period	39; 84	—
SECONDARY Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period	6; 9	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01257347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.