NCT00644267

Brief Summary

We have established a Telemedicine System for chronic disease management. Based on a personal health record, we have successfully used this system in diverse populations, in over 600 patients, and in multiple disease states (heart failure, CVD risk reduction, gestational diabetes). In this proposal, we will enhance this Telemedicine system to support patient centered care (PCC) by increasing access, incorporating hypertension treatment guideline, quality measures, automating reminders and feedback for both patients and health care providers. Inner-city, primarily African-American patients (N=252) with uncontrolled hypertension (BP\<140/90 mmHg) and who are followed by primary care physicians will be randomized to either a usual care or a telemedicine group (Telemedicine plus usual care). Blood pressure, weight, BMI, blood glucose and lipids, and physical activity will be measured at baseline and at 6 months. We hypothesize that more subjects in the telemedicine group will achieve goal blood pressure than in the control group. This will occur through increases in knowledge, self-management, shared decision-making, and improved doctor-patient interaction. Primary end- point will be the proportion of subjects who achieve goal blood pressure. Secondary end-points will include: Rate of self-monitoring, steps per day, weight, CVD knowledge, number of patients at medication guidelines, and increased satisfaction with practice. Telemedicine utilization will also be determined. We believe that telemedicine can facilitate PCC and reduce blood pressure in a cost effective manner.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
242

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 1, 2010

Status Verified

September 1, 2010

Enrollment Period

2.5 years

First QC Date

March 24, 2008

Last Update Submit

September 30, 2010

Conditions

Hypertension

Keywords

hypertensioncardiovascular riskrisk score

Outcome Measures

Primary Outcomes (1)

  • Lowering of blood pressure from hypertension to prehypertension in 50% of study subjects

    6 months

Secondary Outcomes (1)

  • significant reduction in systolic blood pressure in the telemedicine arm

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Subjects will use a telemedicine system for blood pressure control

Behavioral: Telemedicine

2

NO INTERVENTION

Patients with hypertension receiving usual care by a primary care physician

Behavioral: Telemedicine

Interventions

TelemedicineBEHAVIORAL

Telemedicine reporting of blood pressure, weight, physical activity

Also known as: Internet, world wide web
12

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • uncontrolled hypertension
  • systolic blood pressure \> 140
  • access to a telephone or internet

You may not qualify if:

  • angina
  • cognitive defects, dementia
  • end stage renal disease
  • living in nursing or boarding homes
  • pregnant
  • unable to sign informed consent
  • unable to use a scale, sphygmomanometer, pedometer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

  • Bove AA, Homko CJ, Santamore WP, Kashem M, Kerper M, Elliott DJ. Managing hypertension in urban underserved subjects using telemedicine--a clinical trial. Am Heart J. 2013 Apr;165(4):615-21. doi: 10.1016/j.ahj.2013.01.004. Epub 2013 Mar 6.

    PMID: 23537980DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Alfred A Bove, MD PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2008

First Posted

March 26, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 1, 2010

Record last verified: 2010-09

Locations

US(1)