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OpenTrials
Completed

NCT Number: NCT00277381

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated feedback regarding drug adherence

Behavioral

Primary outcomes

  1. Adherence rates as measured using data held in the SIMpill database

  2. Patient satisfaction with intervention as assessed by questionnaire at the end of the study.

  3. Technical difficulties as assessed by interview at the end of the study and by review of the technical log.

Secondary outcomes

  1. Discontinuation rates of medication as assessed at the end of trial debrief.

  2. Changes to medication regime as assessed at the end of trial debrief.

  3. Adverse events (e.g. hospitalisation) as assessed from the log of withdrawals from the trial.

  4. Blood pressure as measured on enrollment and at end of trial debrief.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 16, 2006
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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