Telehealth & Remote Measurement Technologies to Improve Medication Adherence in Hypertension

NCT01439256 | Completed

• 1 other identifier: H-28783
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  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.

  Up to 1 year

Secondary Outcomes (1)

• Medication Adherence

  Up to 1 year

Study Arms (2)

Computer Controlled Telephone Counseling

EXPERIMENTAL

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; Other: Physician information and management recommendations

Usual Care

NO INTERVENTION

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.

Interventions

Computer Controlled Telephone Counseling BEHAVIORAL

The subjects in the intervention arm receive medication adherence counseling through a computer controlled telephone counseling program

Computer Controlled Telephone Counseling

Physician information and management recommendations OTHER

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.

Computer Controlled Telephone Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Not having a patient or patients in the study.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (4)

• 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.

  PMID: 8722429 BACKGROUND

• 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.

  PMID: 18020844 BACKGROUND

• 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.

  PMID: 3192895 BACKGROUND

• 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.

  PMID: 9391929 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ramesh Farzanfar, PhD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BUMC Faculty

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 23, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)