Skip to main content
Clinical Trials/NCT00542204
NCT00542204
Completed
N/A

Patient-Centered Online Disease Management Using a Personal Health Record System

Palo Alto Medical Foundation3 sites in 1 country415 target enrollmentMarch 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Palo Alto Medical Foundation
Enrollment
415
Locations
3
Primary Endpoint
Hemoglobin A1C
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management (CCCM) program that actively supports a partnership between the patient and his/her multidisciplinary care management (CM) team using an online disease management (ODM) system, which is integrated with a comprehensive electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. The CCCM program builds upon CM strategies proven effective in past studies and creates an ODM system that is built upon and fully integrated with a leading, commercially available EHR product - providing a blueprint for instituting customized, continuous care management for many different chronic conditions in a range of ambulatory care settings.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
August 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul Tang

Vice President

Palo Alto Medical Foundation

Eligibility Criteria

Inclusion Criteria

  • \>= 18 years of age
  • Have a designated Palo Alto Medical Foundation Primary Care Provider (PCP)
  • Seen in primary or specialty care at the Palo Alto Division at least once in the preceding 24 months
  • Diagnosis of diabetes
  • Baseline A1C \>= 7.5%

Exclusion Criteria

  • Initial diagnosis of diabetes within the last 12 months
  • Diagnosis of Type 1 diabetes
  • Inability to speak and read in English
  • Lack of regular access to a computer with Internet and email capabilities
  • Unwilling to perform any self-monitoring at home, including blood glucose and blood pressure%
  • Pregnant, planning to become pregnant, or lactating
  • Currently enrolled in a care management program at Palo Alto Medical Foundation or elsewhere
  • PCP determination that the study is inappropriate or unsafe for the patient
  • Investigator discretion for clinical safety or protocol adherence reasons

Outcomes

Primary Outcomes

Hemoglobin A1C

Time Frame: Baseline, 6 months and 12 months

Secondary Outcomes

  • Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise)(Baseline, 6 months and 12 months)
  • Cardiovascular risk (e.g., blood pressure and lipids)(Baseline, 6 months and 12 months)
  • Patient experience and satisfaction (e.g., relevant CAHPS measures)(Baseline and 12 months)
  • Patient psychosocial well-being (e.g., diabetes-related emotional distress)(Baseline, 6 months and 12 months)
  • Processes of care (e.g., frequency of lab testing)(Baseline, 6 months and 12 months)

Study Sites (3)

Loading locations...

Similar Trials