NCT00221455

Brief Summary

We seek to determine if patient data entry, data entered based alerts, and data review in a secure patient portal may provide a sustainable approach to improve diabetic outcomes in a cost effective manner. We plan to study the extent to which the portal can improve diabetic outcomes and quality of care. We recognize, however, that some patients will be more predisposed to adopting technology and some will be more predisposed to improving their compliance than others. Hence, we will also develop and test interventions that may improve adoption and compliance. The goals of the proposed study are: 1) to assess whether a web portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics of patients whose health behavior improves over the study period; 2b) to describe the characteristics of patients who adopt the web portal-based disease management technology; 3) to develop and test targeted interventions to increase the adoption of the web portal and improve patient health behavior; and 4) to monitor the ongoing costs associated with the web portal and patient healthcare resource utilization, and to monitor the incremental costs of the interventions designed to improve utilization of the technology and patient compliance with their diabetic regimens.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_1 diabetes-mellitus

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2011

First QC Date

September 15, 2005

Last Update Submit

July 25, 2011

Conditions

Keywords

Diabetes MellitusChronic disease managementPatient portalPatient empowerment

Outcome Measures

Primary Outcomes (1)

  • Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.

Secondary Outcomes (1)

  • Technology Adoption will be measured by tracking the patient usage of the various portal features

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

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    BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes MellitusPatient Participation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Martin Harris, MD, MBA

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR
  • Holly D Miller, MD, MBA

    The Cleveland Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

September 1, 2004

Study Completion

September 1, 2007

Last Updated

July 27, 2011

Record last verified: 2011-07

Locations