i-STRONGER for Medically Complex
Phase-Based Progress Estimates
Effectiveness
Safety
Aegis Therapies, Frisco, TX
Medically Complex+4 More
i-STRONGER - OtherEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This cluster randomized clinical trial seeks to provide large-scale, foundational evidence that high-intensity rehabilitation is effective and can be systematically implemented to improve functional outcomes for patients admitted to skilled nursing facilities following hospitalization. Additionally, this study will generate a descriptive overview of factors that predict implementation success while informing effective implementation strategies for future skilled nursing facilities innovation.
Eligible Conditions
- Medically Complex
- Functional Recovery
- Aging
- Skilled Nursing Facility
- Deconditioning
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Assessed from 16 months up to 22 months
Month 22
RE-AIM Component: Maintenance
Day 21
Change in Gait Speed
Change in Short Physical Performance Battery (SPPB)
Change in Total Score Modified Barthel ADL Index (MBI)
Day 30
Post-discharge Rehospitalization Rate
Up to 16 months
RE-AIM Component: Adoption
RE-AIM Component: Implementation
RE-AIM Component: Reach
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Usual Care
1 of 2
i-STRONGER
1 of 2
Active Control
Experimental Treatment
2880 Total Participants · 2 Treatment Groups
Primary Treatment: i-STRONGER · No Placebo Group · N/A
i-STRONGER
Other
Experimental Group · 1 Intervention: i-STRONGER · Intervention Types: OtherUsual Care
Other
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: OtherTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed from 16 months up to 22 months
Closest Location: Aegis Therapies · Frisco, TX
N/AFirst Recorded Clinical Trial
1 TrialsResearching Medically Complex
0 CompletedClinical Trials
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,554 Previous Clinical Trials
1,907,648 Total Patients Enrolled
Aegis Therapies, Inc.UNKNOWN
National Institute on Aging (NIA)NIH
1,348 Previous Clinical Trials
3,259,017 Total Patients Enrolled
Jennifer Stevens-Lapsley, PhDPrincipal InvestigatorUniversity of Colorado, Denver
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are at least 50 years of age.
You are a patient.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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