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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up updated every six months for the active three year intervention period.

Awards & highlights

IC Trial 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.

IC Trial 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.

IC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and every three months for a 12 month intervention period.

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

IC 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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,720 Previous Clinical Trials

16,341,411 Total Patients Enrolled

18 Trials studying Diabetes

107,220 Patients Enrolled for Diabetes

Patient-Centered Outcomes Research InstituteOTHER

550 Previous Clinical Trials

29,995,548 Total Patients Enrolled

6 Trials studying Diabetes

2,846,076 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives does this research endeavor seek to accomplish?

"This trial's primary objective is to observe the change in participants' health status over a three year intervention period, which will be evaluated every six months. Other key metrics include patient satisfaction (measured with the Patient Assessment of Care for Chronic Conditions survey), quality of life and enjoyment (assessed through Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form) and functional capabilities (calculated using PROMIS Physical Function - Short Form 6b)."

Answered by AI

Are any opportunities available for participants to join this experiment?

"According to the clinicaltrials.gov portal, this clinical trial is not currently recruiting new candidates; it was initially posted on April 23rd 2018 and most recently updated on May 11th 2022. However, there are a plethora of other studies in need of participants at this moment in time - 4674 trials total!"

Answered by AI