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Improving Adherence in Patients With Hypertension - A Novel Use of Communication Technology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph C. Kvedar, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00277381
First received: January 13, 2006
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

Treating hypertension is known to decrease morbidity and mortality. Despite this 70% of patients do not have adequately controlled blood pressure. The main reason for this is non-adherence to recommended drug therapy. Although strategies have been developed to improve adherence many are time consuming and expensive. We propose to use communications technology to develop a novel means of improving adherence to antihypertensive therapy. We will conduct a randomised, single-blinded, controlled study to assess the impact of a real-time, automated reminder system on adherence rates. This will involve adapting two pieces of currently available technology - the electronic pill bottle and the Ambient Globe. The Globe will change colour in response to information received, via a wireless link, from the patient's electronic pill bottle. We hypothesise that this will provide patients with an up to date, but unobtrusive, reminder of their adherence status and thus effect positive behavioural change. We will measure the impact of this intervention on adherence rates as well as assessing patient views and the impact on provider workload. This trial will elucidate the role of communications technology in improving adherence behaviour and allow us to develop further strategies to tackle this major health issue.


Condition Intervention
Hypertension
 Behavioral: Automated feedback regarding drug adherence

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: Improving Adherence in Patients With Hypertension - A Novel Use of Communication Technology

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Adherence rates as measured using data held in the SIMpill database
  • Patient satisfaction with intervention as assessed by questionnaire at the end of the study.
  • Technical difficulties as assessed by interview at the end of the study and by review of the technical log.

Secondary Outcome Measures:
  • Discontinuation rates of medication as assessed at the end of trial debrief.
  • Changes to medication regime as assessed at the end of trial debrief.
  • Adverse events (e.g. hospitalisation) as assessed from the log of withdrawals from the trial.
  • Blood pressure as measured on enrollment and at end of trial debrief.

Enrollment: 84
Study Start Date: July 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prescription of a once-a-day dose of atenolol.
  • Morisky Score of less than or equal to 2 (explanation in 'Equitable Selection of Subjects').
  • Fluency in English.
  • Age 45-65 inclusive.
  • Primary Care Physician consent to the patient taking part.

Exclusion Criteria:

  • Patients prescribed more than two anti-hypertensive agents.
  • Patients prescribed more than four medications in total.
  • Patients on secondary prevention following cardiac event or stroke.
  • Morisky Score of more than 2.
  • Patients with visual impairment or color-blindness.
  • Patients with congenital or acquired cognitive impairment.
  • Patients with a cardiac pacemaker
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277381

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Joseph C. Kvedar, MD Partners Healthcare System
  More Information

No publications provided

Responsible Party: Joseph C. Kvedar, Director, Center for Connected Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00277381     History of Changes
Other Study ID Numbers: 2005-P-002248
Study First Received: January 13, 2006
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Adherence
Hypertension
Telemedicine

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013