Skip to main content
OpenTrials
Completed

NCT Number: NCT00542204

Use of Online Personalized Health Record System to Promote Self-Management of Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PAMF Palo Alto Health Care Division, Fremont, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online disease management

Behavioral

The Personalized Health Care Program couples a multidisciplinary care management team with an EHR-integrated Online Disease Management (ODM) system.

Other names: EMPOWER-D

Primary outcomes

  1. Hemoglobin A1C

    Time frame: Baseline, 6 months and 12 months

Secondary outcomes

  1. Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise)

    Time frame: Baseline, 6 months and 12 months

  2. Processes of care (e.g., frequency of lab testing)

    Time frame: Baseline, 6 months and 12 months

  3. Cardiovascular risk (e.g., blood pressure and lipids)

    Time frame: Baseline, 6 months and 12 months

  4. Patient experience and satisfaction (e.g., relevant CAHPS measures)

    Time frame: Baseline and 12 months

  5. Patient psychosocial well-being (e.g., diabetes-related emotional distress)

    Time frame: Baseline, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Palo Alto Medical Foundation

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Sutter Health

Registry information

Official study title

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

Acronym: EMPOWER-D

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 10, 2007
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.