Using a Telemedicine System to Promote Patient Care Among Underserved Individuals (AHRQ)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Temple University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00644267
First received: March 24, 2008
Last updated: September 30, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Telemedicine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Using a Telemedicine System to Promote Patient Care Among Underserved Individuals

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Lowering of blood pressure from hypertension to prehypertension in 50% of study subjects [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • significant reduction in systolic blood pressure in the telemedicine arm [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: April 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subjects will use a telemedicine system for blood pressure control
Behavioral: Telemedicine
Telemedicine reporting of blood pressure, weight, physical activity
Other Name: Internet, world wide web
No Intervention: 2
Patients with hypertension receiving usual care by a primary care physician
Behavioral: Telemedicine
Telemedicine reporting of blood pressure, weight, physical activity
Other Name: Internet, world wide web

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644267

Locations
United States, Pennsylvania
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Alfred A Bove, MD PhD Temple University
  More Information

No publications provided by Temple University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alfred A. Bove, MD, PhD, Temple University
ClinicalTrials.gov Identifier: NCT00644267     History of Changes
Other Study ID Numbers: AHRQ (DHHS)-1R18HS017202, AHRQ-1R18HS017202
Study First Received: March 24, 2008
Last Updated: September 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
hypertension
cardiovascular risk
risk score

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014