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

NCT ID: NCT00277381

Last Updated: 2013-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-01-31

Brief Summary

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Interventions

Automated feedback regarding drug adherence

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph C. Kvedar

Director, Center for Connected Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph C. Kvedar, MD

Role: PRINCIPAL_INVESTIGATOR

Partners Healthcare System

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2005-P-002248

Identifier Type: -

Identifier Source: org_study_id