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High-Touch, High-Tech Care for Chronic Conditions (IC Trial)

N/A
Waitlist Available
Led By Dan Swayze, DrPH, MBA
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Enrollment Phase I: Medicaid or dual-eligible (Medicare-Medicaid) adults age 21 years and older with Multiple Chronic Conditions (MCC)
Enrollment Phase II: Be insured through physical and/or behavioral health payers within the UPMC ISD
Must not have
Individuals who are unable to operate a smart phone due to reasons of literacy, vision or dexterity
Individuals on hemodialysis for kidney disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up updated every six months for the active three year intervention period.
Awards & highlights

Summary

This trial will enroll 1,927 adults with multiple chronic conditions who are at risk for repeated hospitalizations. The investigators will assess the impact of three payer-led options (e.g. High-Touch, High-Tech, Usual Care) on patient-centered outcomes, namely patient activation in health care, health status, and subsequent re-hospitalization.

Who is the study for?
Adults over 21 in Pennsylvania with multiple chronic conditions like heart disease, high blood pressure, COPD, or diabetes. They must be insured through UPMC ISD and not pregnant, in active cancer treatment, in nursing facilities, on hemodialysis for kidney disease or unable to use a smartphone.Check my eligibility
What is being tested?
The study tests three care options for people with multiple health issues: usual care with optimal discharge planning; High-Touch (personalized support); and High-Tech (technology-based assistance). It aims to see which improves patient involvement and health while reducing re-hospitalizations.See study design
What are the potential side effects?
This trial does not involve medication so typical drug side effects are not expected. However, participants may experience stress or discomfort from changes in their healthcare routine or the burden of additional monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 21, have Medicaid or Medicare-Medicaid, and multiple chronic conditions.
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I am insured by UPMC for health services.
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I have a physical health condition like heart disease or diabetes.
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I am over 21, on Medicaid or Medicare-Medicaid, and have multiple chronic conditions.
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I am over 21, on Medicaid or Medicare-Medicaid, and have multiple chronic conditions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot use a smartphone because of issues with reading, seeing, or using my hands.
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I am on hemodialysis for kidney disease.
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I am currently receiving treatment for cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and every three months for a 12 month intervention period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every three months for a 12 month intervention period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Health Status
Change in Hospital Readmission Rate
Patient activation
Secondary outcome measures
Care satisfaction
Emergent care
Engagement in primary, specialty, mental health care
+3 more

Trial Design

3Treatment groups
Active Control
Group I: High-TouchActive Control1 Intervention
Delivered primarily via face-to-face interactions, with telephonic interactions and information sharing that does not require access to mobile devices or the Internet. In-person support and/or telephonic interactions to occur at least four times over at least a four-month period.
Group II: High-TechActive Control1 Intervention
Delivered via a remote care management platform and digital health tools. Remote care support interactions to occur for at least a four-month period.
Group III: Usual CareActive Control1 Intervention
Delivered via Health Plan support and resources within 14 days of an initial home or telephonic visit.

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
563 Previous Clinical Trials
29,990,750 Total Patients Enrolled
6 Trials studying Diabetes
2,846,076 Patients Enrolled for Diabetes
University of PittsburghLead Sponsor
1,737 Previous Clinical Trials
16,337,857 Total Patients Enrolled
18 Trials studying Diabetes
107,220 Patients Enrolled for Diabetes
Dan Swayze, DrPH, MBAPrincipal InvestigatorUniversity of Pittsburgh

Media Library

High-Tech Clinical Trial Eligibility Overview. Trial Name: NCT03451630 — N/A
Diabetes Research Study Groups: High-Touch, High-Tech, Usual Care
Diabetes Clinical Trial 2023: High-Tech Highlights & Side Effects. Trial Name: NCT03451630 — N/A
High-Tech 2023 Treatment Timeline for Medical Study. Trial Name: NCT03451630 — N/A
Diabetes Patient Testimony for trial: Trial Name: NCT03451630 — N/A
~195 spots leftby Jul 2025