Telehealth & Remote Measurement Technologies to Improve Medication Adherence in Hypertension

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.

Inclusion Criteria for Patients:

- A patient at one of the two primary care practices of General Internal Medicine, or
in Family Medicine, Boston Medical Center (BMC), whose Primary Care Physician (PCP)
is participating in the study.

- A diagnosis of hypertension on the active problem list.

- BP > 140/90 (over 130/80 if diabetic) for two or more consecutive visits (any clinic
in the hospital, not limited to PCP but excluding Emergency Department(ED)) over the
prior 12 months.

- Having been prescribed at least one anti-hypertension medication (currently listed on
the list of prescribed medications).

- Has at least one appointment scheduled with his/her PCP within the next six months.

- Age 18 and over.

- Is planning to continue his/her primary care at Boston Medical Center for at least
the next 7 months.

- Is willing and able to use the electronic medication tray unassisted to take the
study-selected medication for the next seven months.

Inclusion Criteria for Physicians:

- Be a primary care physician in General Internal Medicine, BMC, or be a primary care
physician in Family Medicine, BMC, or be a resident in General Internal Medicine,
BMC.

- Have a patient who is eligible and participates in the study.

Exclusion Criteria for Patients:

- Planning to move from the Boston area during the study period.

- No home telephone or touch tone service.

- Cannot use a telephone unassisted.

- Is not willing to receive calls at his/her phone during the study period.

- Does not understand conversational English over the telephone.

- Currently enrolled in the TLC-MultiDisease study.

- Is planning to use another electronic medication tray or bottle (such as Medication
Events Monitoring Systems (MEMS) to take the study-selected medication for the next
seven months.

Exclusion Criteria for Physicians:

- Not having a patient or patients in the study.