Telehealth & Remote Measurement Technologies to Improve Medication Adherence in Hypertension (HTNMedTrack)
Behavioral: Computer Controlled Telephone Counseling
Other: Physician information and management recommendations
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Health Services Research
|Official Title:||Telehealth & Remote Measurement Technologies to Improve Medication Adherence in Hypertension|
- Blood Pressure [ Time Frame: Up to 1 year ]This study will follow the Joint National Committee's (JNC) recommendations for blood pressure. JNC recommends that blood pressure should be reduced to less than 140/90 mm Hg. In this study the investigators will consider blood pressure as a continuous variable and as a binary categorical variable, following the guidelines of the JNC on blood pressure evaluation.
- Medication Adherence [ Time Frame: Up to 1 year ]
Adherence at or over 80% is considered overall medication adherence.
It is likely that some patient subjects in the intervention group who increase their medication regimen adherence will experience a reduction in their blood pressure. In rare instances, this reduction might lead to a syncopal episode or other medical complications due to hypotension. The investigators expect that such events will be exceedingly rare, yet, possible. TLC is designed to monitor for occurrence of hypotension, and if it occurs, TLC will generate an alert to the patient-subjects' responsible physicians.
|Study Start Date:||September 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Computer Controlled Telephone Counseling
This arm intervenes with subjects and their treating physicians. The intervention is periodic medical adherence promotion counseling for subjects regarding their prescribed HTN medications through a computer-controlled telephone counseling program that has data on subject's recent BP values and their prescribed HTN medications. The subjects' treating physicians receive at regularly scheduled office visits information about subject's recent BP and medication adherence for each prescribed medication and also get physician information and management recommendations
Behavioral: Computer Controlled Telephone Counseling
The subjects in the intervention arm receive medication adherence counseling through a computer controlled telephone counseling programOther: Physician information and management recommendations
Treating physicians for those subjects in the intervention arm receive through the medical record system a summary of blood pressure values and adherence data and recommendations.
No Intervention: Usual Care
In this arm, patients with hypertension that is not adequately controlled receive usual care from their physicians. Usual care is defined as receiving regular care from the physician and no additional care or intervention from the study.
The study will use state-of-the-art technologies, including two systems that use a telephone-based platform called TLC (Telephone-Linked Care). The two TLC applications have been developed for patients with hypertension (TLC-HTN) as well as patients who have difficulty adhering to their medication regimen (TLC-MED). The investigators will also use state-of-the-art medication monitoring technology (electronic pill trays) that monitor patients' medication-taking behaviors in the intervention and control arms.
The TLC-HTN system was designed for patients with hypertension (HTN) whose blood pressure (BP) was out of control and who were given a home blood pressure monitor. All study subjects (intervention and control) were asked to take their blood pressure at home on a weekly basis. The system gave them feedback on how the reported blood pressure compared to their previous blood pressure values and goals set by their physician. Using self-reported medication-taking behavior provided to the TLC-MED module, TLC-HTN gave the patient additional feedback that linked their adherence to their blood pressure control. At the end of each weekly TLC-HTN conversation, the system sent a report to the patient's physician that displayed recent and previous blood pressure values, identified trends, compared the blood pressures to the physician's goal for the patient and accepted norms, and displayed anti-hypertensive medication use/adherence levels in a similar manner so that the physician could relate adherence to blood pressure control.
TLC-Medication Adherence (TLC-MED): TLC-MED is an additional module that is added to the TLC chronic disease systems including TLC-HTN, with the purpose of promoting medication regimen adherence. In each TLC conversation, TLC-MED will assess the patient's adherence to the medications prescribed for that disease. In this project, the investigators will evaluate two versions of TLC-MED, one which uses an electronic medication event monitoring system to determine medication taking, and the other which uses patient self-report information for determining the same information. The investigators will compare both the self-report method of obtaining medication-taking behavior/adherence and the electronic pill trays to usual care.
Commercially available electronic pill trays for oral, solid medications (e.g., tablets and capsules) will be used by both arms to assess patient medication adherence along with subject self-report of medication-taking. There are a number of methods for conducting medication event monitoring for solid medications. The investigators will use electronic pill trays, consisting of a pillbox containing 28 cups arranged in a 7x4 matrix. Each cup has a sensor that registers when the cup is opened.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439256
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Ramesh Farzanfar, PhD||Boston Medical Center|