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Weekly Check-in appointment with study team or provider for Frailty (PRIMER Trial)
N/A
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be wait-listed, in transplant evaluation, or "Penn Ready" with a MELD-Na score less than or equal to 25;
Patients must be English speaking and own/use a smartphone and cognitively able to consent;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
PRIMER Trial Summary
This trial will test whether a pre-transplant intervention can improve physical function and reduce frailty in adult Liver Transplant candidates.
Eligible Conditions
- Frailty
- Liver Disease
PRIMER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPRIMER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of the Intervention
Feasibility of the Intervention
Secondary outcome measures
Body composition/BIA
Grip strength
Grip strength level relative to BMI
+1 moreOther outcome measures
Clinical Outcomes from Medical Record Review - Death
Clinical Outcomes from Medical Record Review - Hospitalization
Clinical Outcomes from Medical Record Review - Liver Transplant listing
+2 morePRIMER Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2 - Intervention armExperimental Treatment3 Interventions
Physical activity program supported by financial incentives for meeting walking goals and participating in weekly check-in appointments with study team members via telephone calls. Participants in the intervention arm will also receive twice-daily medication reminders via bidirectional text messages to promote medication adherence. Participants in Arm 2 will also receive personalized nutrition and exercise counseling, daily feedback on step counts via the Nokia GO wearable step tracker and their smartphones, and an end-of-study assessment.
Group II: Arm 1 - Control ArmExperimental Treatment1 Intervention
Usual care, nutrition and exercise counseling at baseline, use of the Nokia GO wearable step tracker device and end-of-study assessment at the end of the 14-week study period. Participants will receive the Nokia GO wearable step tracker to monitor daily step counts, but they will not be provided with personalized walking goals or automated feedback on goal attainment via text message.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nokia GO Wearable StepTracker
2018
N/A
~30
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
1,992 Previous Clinical Trials
42,875,330 Total Patients Enrolled
4 Trials studying Frailty
36 Patients Enrolled for Frailty
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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