NCT02169999

Brief Summary

The purpose of this study is to determine the impact of web-based personalized decision support on:

  1. 1.Patient awareness of treatment goal options and ability to articulate their goals of diabetes care.
  2. 2.Provider awareness of patients' clinical status (e.g. life expectancy) and treatment preferences.
  3. 3.Individualization of care plans in accordance with geriatric diabetes guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable diabetes

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

June 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

2.5 years

First QC Date

June 18, 2014

Last Update Submit

February 17, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients' change in knowledge about diabetes and its treatments

    We asked patients to identify knowledge of an A1C goal and specific goals for glucose control in pre and post surveys for both arms.

    06/2011 - 12/2013 (32 months)

Secondary Outcomes (1)

  • Patients' Change in Decisional Conflict Scores

    6/2011 - 12/2013 (32 months)

Study Arms (2)

Personalized Diabetes Care Website

EXPERIMENTAL

Subjects are exposed to Personalized Diabetes Care website.

Other: Personalized Diabetes Care Website

No Exposure To Website

NO INTERVENTION

Subjects are not exposed to Personalized Diabetes Care website

Interventions

Subjects enrolled in the intervention view the Personalized Diabetes Care website and enter their self-reported medical history and personal preferences into the website. A model runs and creates a 2 page print out with risk estimates for the subject to review with their physician.

Personalized Diabetes Care Website

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • Dx of diabetes
  • HbA1C greater than 6.0%
  • English speaking

You may not qualify if:

  • Telephone Mini Mental less than 17
  • Blind

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Huang ES, Nathan AG, Cooper JM, Lee SM, Shin N, John PM, Dale W, Col NF, Meltzer DO, Chin MH. Impact and Feasibility of Personalized Decision Support for Older Patients with Diabetes: A Pilot Randomized Trial. Med Decis Making. 2017 Jul;37(5):611-617. doi: 10.1177/0272989X16654142. Epub 2016 Jun 16.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Elbert S Huang

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 23, 2014

Study Start

June 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 19, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations