NCT03692208

Brief Summary

The purpose of this novel patient-facing disease management intervention is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2018

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

First Submitted

Initial submission to the registry

September 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

February 21, 2023

Completed
Last Updated

February 21, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

September 20, 2018

Results QC Date

April 8, 2022

Last Update Submit

January 25, 2023

Conditions

Diabetes Mellitus, Type 2

Keywords

Geriatrics

Outcome Measures

Primary Outcomes (1)

  • Documentation of Diabetes Goal

    Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).

    Baseline, 6 months

Secondary Outcomes (2)

  • Personalized A1C Goals

    Baseline, 6 months

  • Patient Ability to Reach Personalized Goals

    Baseline, 6 month

Other Outcomes (1)

  • Health Care Utilization

    1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart.

Behavioral: My Diabetes Goal Survey and Optional Care Management

Delayed Intervention/Control

ACTIVE COMPARATOR

Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated above.

Behavioral: My Diabetes Goal Survey and Optional Care Management

Interventions

My Diabetes Goal Survey and Optional Care ManagementBEHAVIORAL

The intervention is already described in the intervention arm description.

Delayed Intervention/ControlIntervention

Eligibility Criteria

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

You may qualify if:

  • years and older
  • Diagnosis of Type 2 Diabetes
  • Enrolled in MyChart (University of Chicago Patient Portal)
  • Outpatient clinic visit in the prior year

You may not qualify if:

  • Under 64 years of age
  • No type 2 diabetes
  • Not enrolled in MyChart
  • No outpatient clinic visit in the prior year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Zhu M, Cui M, Nathan AG, Press VG, Wan W, Miles C, Ali R, Pusinelli M, Huisingh-Scheetz M, Huang ES. A nurse driven care management program to engage older diabetes patients in personalized goal setting and disease management. Health Sci Rep. 2024 Jun 23;7(6):e2208. doi: 10.1002/hsr2.2208. eCollection 2024 Jun.

    PMID: 38915356DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Elbert Huang
Organization
The University of Chicago
ehuang@medicine.bsd.uchicago.edu
(773) 834-9143

Study Officials

  • Elbert S Huang, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2018

First Posted

October 2, 2018

Study Start

October 29, 2018

Primary Completion

August 12, 2020

Study Completion

September 29, 2020

Last Updated

February 21, 2023

Results First Posted

February 21, 2023

Record last verified: 2023-01

Locations

US(1)