Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-31 @ 3:26 PM
Study NCT ID:
NCT01439256
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2011-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth & Remote Measurement Technologies to Improve Medication Adherence in Hypertension
Sponsor:
Boston Medical Center
Organization:
Study Overview
Official Title:
Telehealth & Remote Measurement Technologies to Improve Medication Adherence in Hypertension
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HTNMedTrack
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: