Use of Online Personalized Health Record System to Promote Self-Management of Diabetes (EMPOWER-D)

April 27, 2015 updated by: Paul Tang, Palo Alto Medical Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

415

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fremont, California, United States, 94538
        • PAMF Palo Alto Health Care Division
      • Los Altos, California, United States, 94022
        • PAMF Palo Alto Health Care Division
      • Mountain View, California, United States, 94040
        • PAMF Camino Region
      • Palo Alto, California, United States, 94301
        • PAMF Palo Alto Health Care Division
      • Redwood City, California, United States, 94063
        • PAMF Palo Alto Health Care Division
      • Santa Cruz, California, United States, 95062
        • PAMF Santa Cruz Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online disease management
The PAMFOnline-mediated Personalized Health Care Program, which couples a multidisciplinary diabetes care management team with an EHR-integrated Online Disease Management (ODM) system.
Behavioral: Online disease management
The Personalized Health Care Program couples a multidisciplinary care management team with an EHR-integrated Online Disease Management (ODM) system.
Other Names:
  • EMPOWER-D
No Intervention: Usual care
Usual medical care. No access to the PHCP electronic system and self-management tools supporting this care management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1C
Time Frame: Baseline, 6 months and 12 months
Baseline, 6 months and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Medical Foundation

Collaborators

Agency for Healthcare Research and Quality (AHRQ)
Sutter Health

Investigators

  • Principal Investigator: Paul Tang, M.D., Palo Alto Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

October 9, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R18HS017179-01 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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