Clinical trial NCT00277381: Improving Adherence in Patients With Hypertension - A Novel Use of Communication Technology
Official title: Improving Adherence in Patients With Hypertension - A Novel Use of Communication Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Adherence
Hypertension
Telemedicine
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2006-01-16
Enrollment: 84
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.


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

Primary outcomes:
measure: Adherence rates as measured using data held in the SIMpill database
measure: Patient satisfaction with intervention as assessed by questionnaire at the end of the study.
measure: Technical difficulties as assessed by interview at the end of the study and by review of the technical log.
Secondary outcomes:
measure: Discontinuation rates of medication as assessed at the end of trial debrief.
measure: Changes to medication regime as assessed at the end of trial debrief.
measure: Adverse events (e.g. hospitalisation) as assessed from the log of withdrawals from the trial.
measure: Blood pressure as measured on enrollment and at end of trial debrief.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Partners Healthcare System
name: Joseph C. Kvedar, MD
role: PRINCIPAL_INVESTIGATOR
References: