Clinical trial NCT01439256: Telehealth & Remote Measurement Technologies to Improve Medication Adherence in Hypertension
Official title: Telehealth & Remote Measurement Technologies to Improve Medication Adherence in Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study focuses on an important patient behavior, medication-taking, and important physician behaviors: promoting medication regimen adherence in patients and appropriately modifying therapy when existing therapy results in inadequate therapeutic effect. The study will also explore the caregivers' (clinicians) behavior after relevant information about their patients' medication adherence and blood pressure control has been provided to them. The investigators focus on behavior change for patients and physicians and seek to change their behaviors to improve the health care delivery process and outcomes. The study aims at facilitating tertiary prevention of cardiovascular, cerebrovascular, and reno-vascular diseases by promoting better blood pressure control.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood Pressure
timeFrame: Up to 1 year
Secondary outcomes:
measure: Medication Adherence
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Ramesh Farzanfar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friedman RH, Kazis LE, Jette A, Smith MB, Stollerman J, Torgerson J, Carey K. A telecommunications system for monitoring and counseling patients with hypertension. Impact on medication adherence and blood pressure control. Am J Hypertens. 1996 Apr;9(4 Pt 1):285-92. doi: 10.1016/0895-7061(95)00353-3.
citation: King AC, Friedman R, Marcus B, Castro C, Napolitano M, Ahn D, Baker L. Ongoing physical activity advice by humans versus computers: the Community Health Advice by Telephone (CHAT) trial. Health Psychol. 2007 Nov;26(6):718-27. doi: 10.1037/0278-6133.26.6.718.
citation: Kazis LE, Friedman RH. Improving medication compliance in the elderly. Strategies for the health care provider. J Am Geriatr Soc. 1988 Dec;36(12):1161-2. doi: 10.1111/j.1532-5415.1988.tb04406.x. No abstract available.
citation: Friedman RH, Stollerman JE, Mahoney DM, Rozenblyum L. The virtual visit: using telecommunications technology to take care of patients. J Am Med Inform Assoc. 1997 Nov-Dec;4(6):413-25. doi: 10.1136/jamia.1997.0040413.