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

NCT ID: NCT00542204

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Online disease management

Intervention Type BEHAVIORAL

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

Usual care

Usual medical care. No access to the PHCP electronic system and self-management tools supporting this care management.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Online disease management

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EMPOWER-D

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Sutter Health

OTHER

Sponsor Role collaborator

Palo Alto Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Paul Tang

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Tang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Medical Foundation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

PAMF Palo Alto Health Care Division

Fremont, California, United States

Site Status

PAMF Palo Alto Health Care Division

Los Altos, California, United States

Site Status

PAMF Camino Region

Mountain View, California, United States

Site Status

PAMF Palo Alto Health Care Division

Palo Alto, California, United States

Site Status

PAMF Palo Alto Health Care Division

Redwood City, California, United States

Site Status

PAMF Santa Cruz Medical Clinic

Santa Cruz, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23171659 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R18HS017179-01

Identifier Type: AHRQ

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Internet Diabetes Self-Management
NCT00372463 COMPLETED PHASE2