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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Palo Alto Medical Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
Sutter Health
Information provided by (Responsible Party):
Paul Tang, Palo Alto Medical Foundation
ClinicalTrials.gov Identifier:
NCT00542204
First received: October 9, 2007
Last updated: August 22, 2011
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Behavioral: Online disease management
Other: Usual care - no intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Patient-Centered Online Disease Management Using a Personal Health Record System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Palo Alto Medical Foundation:

Primary Outcome Measures:
  • Hemoglobin A1C [ Time Frame: Baseline, 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise) [ Time Frame: Baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Processes of care (e.g., frequency of lab testing) [ Time Frame: Baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Cardiovascular risk (e.g., blood pressure and lipids) [ Time Frame: Baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Patient experience and satisfaction (e.g., relevant CAHPS measures) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Patient psychosocial well-being (e.g., diabetes-related emotional distress) [ Time Frame: Baseline, 6 months and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2008
Estimated Study Completion Date: August 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: EMPOWER-D
No Intervention: Usual care
Usual medical care. No access to the PHCP electronic system and self-management tools supporting this care management.
 Other: Usual care - no intervention
Usual medical care. No access to the electronic system and self-management tools supporting this care management.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542204

Locations
United States, California
PAMF Palo Alto Health Care Division
Fremont, California, United States, 94538
PAMF Palo Alto Health Care Division
Los Altos, California, United States, 94022
PAMF Camino Region
Mountain View, California, United States, 94040
PAMF Palo Alto Health Care Division
Palo Alto, California, United States, 94301
PAMF Palo Alto Health Care Division
Redwood City, California, United States, 94063
PAMF Santa Cruz Medical Clinic
Santa Cruz, California, United States, 95062
Sponsors and Collaborators
Palo Alto Medical Foundation
Agency for Healthcare Research and Quality (AHRQ)
Sutter Health
Investigators
Principal Investigator: Paul Tang, M.D. Palo Alto Medical Foundation
  More Information

No publications provided by Palo Alto Medical Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paul Tang, Vice President, Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT00542204     History of Changes
Other Study ID Numbers: 1 R18 HS017179-01
Study First Received: October 9, 2007
Last Updated: August 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Palo Alto Medical Foundation:
Diabetes
Blood Glucose Self-Monitoring
Home Blood Glucose Monitoring
Internet
Personal Health Record (PHR)
Health Information Technology (HIT)
Care management
Disease Management
 Diabetes self-management
Consumer Health Information
Medical Records Systems, Computerized
Computerized Medical Records System
Automated Medical Records System
Electronic Health Record (EHR)
Remote patient monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013