Recruiting

Digital Health Care

Sponsor:

OSF Healthcare System

Code:

NCT05555095

Conditions

Hypertension

Diabetes Mellitus

Maternal Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

digital health delivered multicomponent intervention

Study Details

Brief summary:

The purpose of this study is to examine the intervention effectiveness and dissemination of digital health care delivery models for improving selected health outcomes in the Medicaid population.

Conditions

Hypertension

Diabetes Mellitus

Maternal Health

Study ID

NCT05555095

Start date

Sep 26, 2022

Status verified date

Apr, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient of one of four medically qualified health care centers and/or OSF HealthCare as defined by insurance type
  • Insured by Medicaid or dually eligible for Medicare or Medicaid
  • Has one or more of the three following conditions:

Hypertension, Diabetes Mellitus, or Pregnancy

  • Able to read and understand English or read translated materials in language provided (e.g. Spanish)
  • Minors who are pregnant and less 18 years of age who are enrolled in the MIC Program

Exclusion Criteria:

  • Not enrolled in the MIC Program
  • No one will be excluded on basis of sex or race

Study Design

Enrollment

19331 participants

Anticipated

Interventions and Outcome Measures

Arms

OSF HealthCare

Subjects from OSF HealthCare

Federally Qualified Health Center (FQHC) - 1

Subjects from Eagle View Community Health System enrolled in MIC Program

Federally Qualified Health Center (FQHC) - 2

Subjects from Chestnut Health System Inc. enrolled in MIC Program

Federally Qualified Health Center (FQHC) - 3

Subjects from Heartland Community Health System enrolled in MIC Program

Federally Qualified Health Center (FQHC) - 4

Subjects from Aunt Martha's enrolled in MIC Program

Interventions

digital health delivered multicomponent intervention

The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.

Primary outcome measure

  • Change in participant's blood pressure control at three points in time [ Time Frame: 3 months, 6 months, 12 months ]
  • Change in participant's glycemic control at three points in time [ Time Frame: 3 months, 6 months, 12 months ]
  • Change in Patient Assessment of Chronic Illness Care scale (PACIC) from baseline to exit from program [ Time Frame: baseline, end of program, on average of 1 year ]
  • Change in Patient Perception of Health Care Management (adapted form of PACIC to reflect pre/postnatal care) from baseline to exit from program [ Time Frame: baseline, end of program, on average 6 months ]
  • Patient satisfaction, 1-item researcher generated question [ Time Frame: at exit from program, on average 1 year ]

Central Contacts and Locations

Central contacts

Colleen J. Klein, PhD, APRN

309-655-3899colleen.klein@osfhealthcare.org

Melinda B Cooling, DNP, APRN

309-624-4649melinda.b.cooling@osfhealthcare.org

Locations

OSF HealthCare System

Recruiting

Peoria, Illinois, United States, 61602

More Information

Sponsor

OSF Healthcare System

Last update posted

Apr 30, 2025

Last verified

Apr, 2025

Keywords

  • hypertension
  • diabetes
  • maternal health
  • digital health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OSF Healthcare System on 2025-04-30.