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

Diabetes Mellitus Clinical Trial

— EMPOWER-D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542204
• Other study ID #: 1R18HS017179-01
• Status: Completed
• Phase: N/A
• First received: October 9, 2007
• Last updated: April 27, 2015
• Start date: March 2008
• Est. completion date: August 2011

Study information

• Verified date: April 2015
• Source: Palo Alto Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	PAMF Palo Alto Health Care Division	Fremont	California
United States	PAMF Palo Alto Health Care Division	Los Altos	California
United States	PAMF Camino Region	Mountain View	California
United States	PAMF Palo Alto Health Care Division	Palo Alto	California
United States	PAMF Palo Alto Health Care Division	Redwood City	California
United States	PAMF Santa Cruz Medical Clinic	Santa Cruz	California

Sponsors (3)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation	Agency for Healthcare Research and Quality (AHRQ), Sutter Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C		Baseline, 6 months and 12 months	No
Secondary	Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise)		Baseline, 6 months and 12 months	No
Secondary	Processes of care (e.g., frequency of lab testing)		Baseline, 6 months and 12 months	No
Secondary	Cardiovascular risk (e.g., blood pressure and lipids)		Baseline, 6 months and 12 months	No
Secondary	Patient experience and satisfaction (e.g., relevant CAHPS measures)		Baseline and 12 months	No
Secondary	Patient psychosocial well-being (e.g., diabetes-related emotional distress)		Baseline, 6 months and 12 months	No