Clinical trial NCT00542204: Use of Online Personalized Health Record System to Promote Self-Management of Diabetes
Official title: Patient-Centered Online Disease Management Using a Personal Health Record System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: 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
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Sutter Health
First posted: 2007-10-10
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise)
timeFrame: Baseline, 6 months and 12 months
measure: Processes of care (e.g., frequency of lab testing)
timeFrame: Baseline, 6 months and 12 months
measure: Cardiovascular risk (e.g., blood pressure and lipids)
timeFrame: Baseline, 6 months and 12 months
measure: Patient experience and satisfaction (e.g., relevant CAHPS measures)
timeFrame: Baseline and 12 months
measure: Patient psychosocial well-being (e.g., diabetes-related emotional distress)
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Fremont
country: United States
facility: PAMF Palo Alto Health Care Division
state: California
city: Los Altos
country: United States
facility: PAMF Palo Alto Health Care Division
state: California
city: Mountain View
country: United States
facility: PAMF Camino Region
state: California
city: Palo Alto
country: United States
facility: PAMF Palo Alto Health Care Division
state: California
city: Redwood City
country: United States
facility: PAMF Palo Alto Health Care Division
state: California
city: Santa Cruz
country: United States
facility: PAMF Santa Cruz Medical Clinic
state: California
Study officials:
affiliation: Palo Alto Medical Foundation
name: Paul Tang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang PC, Overhage JM, Chan AS, Brown NL, Aghighi B, Entwistle MP, Hui SL, Hyde SM, Klieman LH, Mitchell CJ, Perkins AJ, Qureshi LS, Waltimyer TA, Winters LJ, Young CY. Online disease management of diabetes: engaging and motivating patients online with enhanced resources-diabetes (EMPOWER-D), a randomized controlled trial. J Am Med Inform Assoc. 2013 May 1;20(3):526-34. doi: 10.1136/amiajnl-2012-001263. Epub 2012 Nov 20.