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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Online disease management

• Registration Number: NCT00542204
• Lead Sponsor: Palo Alto Medical Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Study Start: 2008-03
• Primary Completion: 2011-03
• Study Completion: 2011-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online disease management	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.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C	Baseline, 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

PAMF Palo Alto Health Care Division; 🇺🇸 Redwood City, California, United States

PAMF Camino Region; 🇺🇸 Mountain View, California, United States

PAMF Santa Cruz Medical Clinic; 🇺🇸 Santa Cruz, California, United States