Liver DiseasesPRIMERNCT03584646

Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation

A study testing Nokia GO Wearable StepTracker, Medication Reminder and Weekly Check-in appointment with study team or provider in people with Liver Diseases and End Stage Liver Disease, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 95 years
Conditions the study is for: Liver Diseases, End Stage Liver Disease, Frailty
What is being tested?: Nokia GO Wearable StepTracker, Medication Reminder and Weekly Check-in appointment with study team or provider
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 28 Feb 2018to 1 Oct 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 95 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
Patient and physician feel that individual can safely participate in an exercise program;
Meeting at least one 'at risk' criterion for impaired physical performance, frailty, or malnutrition (by SPPB, abPG-SG, dynamometer measured grip strength), or physical deconditioning as determined by physical therapist, or treating clinician.

Who cannot join

The patient is unable to provide informed consent;
The patient has been hospitalized within the last 30 days;
A score of 0-3 points on the SPPB assessment indicating inability to participate in a physical activity program or a score of 12 in the absence of frailty or malnutrition (indicating low risk for poor physical or performance or malnutrition);
The patient is at risk for falling as defined by clinician assessment results or if the patient states that he/she has a history of falling (record of a fall(s) in the past 30 days);
The patient is already enrolled in a financial incentive-based exercise program using a wearable device;
Any other medical conditions that would prohibit participation in a physical activity program as determined by transplant clinicians or severe vision, hearing, or mobility impairment precluding participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Development and Testing of a Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation

This is a single center, 2-arm, patient-randomized study evaluating the feasibility and potential efficacy of the PRIMER intervention in improving physical function and reducing frailty in adult Liver Transplant candidates. The intervention will consist of a patient-tailored prehabilitation program designed to reduce frailty, improve physical function and nutritional status, and optimize pre- and post-transplant outcomes.

Read the detailed description

The investigator will pilot-test a two-arm, randomized trial of a prehabilitation intervention in 38 pre-liver transplant patients with End Stage Liver Disease (ESLD). The investigator estimates an attrition rate of 20%, resulting n=30 participants; 10 participants in Arm 1 (control arm) and 20 participants in Arm 2 (intervention arm). To be eligible, patients must be waitlisted or "Penn-Ready" with a MELD-Na less than or equal to 25, English-speaking, able to safely participant in an exercise program, have a smartphone, and be identified as frail. The purpose of this trial is to develop and implement a program of medical optimization, physical activity, and nutrition recommendations specifically tailored to ESLD and designed to reduce frailty, improve physical function, and optimize pre- and post-transplant outcomes.

Conditions: Liver Diseases, End Stage Liver Disease, Frailty
Being tested: Nokia GO Wearable StepTracker, Medication Reminder, Weekly Check-in appointment with study team or provider
Keywords: liver transplantation, malnutrition, exercise, prehabilitation, nutrition, sarcopenia
Medical subject headings: Liver Diseases, End Stage Liver Disease, Frailty, Malnutrition, Motor Activity, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nokia GO Wearable StepTrackerDevice
All participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.
Medication ReminderOther
Medication reminders are sent to participants in Arm 2 on a daily basis.
Weekly Check-in appointment with study team or providerOther
Virtual meeting or telephone call between participants and study team to assess study involvement, adherence to procedures, and following of medical care recommendations.

Study groups in NCT03584646
Study group	Role	What they receive
Arm 1 - Control Arm	Experimental	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. Receives: Device: Nokia GO Wearable StepTracker
Arm 2 - Intervention arm	Experimental	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. Receives: Device: Nokia GO Wearable StepTracker; Other: Medication Reminder; Other: Weekly Check-in appointment with study team or provider

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of the Intervention
Feasibility of the intervention will be evaluated by the percentage of patients that complete the study intervention.
Measured: 14 weeks
Acceptability of the Intervention
Acceptability will be measured using a patient satisfaction questionnaire upon study completion.
Measured: 14 weeks

Secondary outcomes (4)

Performance on the Short Physical Performance Battery (SPPB)
The SPPB is a simple test to measure lower extremity function using tasks that mimic daily activities. The SPPB examines three areas of lower extremity function; static balance, gait speed, and getting in and out of a chair. Static balance is measured in units of time (seconds) and patients are timed holding 3 different stances. Gait speed is measured in time (seconds) to walk 4 meters. Chair sits are measured as the time (seconds) it takes to get up and out of a chair 5 times without using one's arms to assist the exercise. Collectively, the three tests are used to generate a total score (0-12) that reflects a patient's frailty (score of 0) or lack of frailty (score of 12).
Measured: 14 weeks
Grip strength
Grip strength will be measured using a digital hand dynamometer and the unit of measure is kilograms.
Measured: 14 weeks
Grip strength level relative to BMI
Body Mass Index (BMI) will be calculated using height in inches and weight in pounds and reported as 'kg/m^2'. Grip strength will be compared to BMI and a 'BMI-adjusted' grip strength level will be reported using established 'kilogram to BMI ratio' standards.
Measured: 14 weeks
Body composition/BIA
Bioelectrical impedance analysis will be completed using the Bodystat Quadscan 4000, which is a multi-frequency body composition analyzer. Body fat percentage (%) will be compared to lean body mass percentage and total body water percentage to assess sarcopenia and nutritional status.
Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 20181 Oct 2022

First posted12 Jul 2018
Study start28 Feb 2018
Primary completion1 Oct 2022
Study completion1 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Liver DiseasesStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The investigator will conduct a patient-randomized, two-arm pilot study of 38 participants with a predicted attrition rate of 20% resulting in 30 total participants; n=10 in Arm 1 and n=20 in Arm 2. Arm 1 will serve as the control arm and Arm 2 will serve as the intervention arm.
Masking: Single blind
Who is masked: Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03584646
Sponsor's protocol ID: 828669
Acronym: PRIMER
Status last verified: Jan 2023
First submitted: 1 Feb 2018
Last updated: 11 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Testing of a Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation
ClinicalTrials.gov ID: NCT03584646
Acronym / sponsor ID: PRIMER / 828669
Conditions: Liver Diseases, End Stage Liver Disease, Frailty
Keywords: liver transplantation, malnutrition, exercise, prehabilitation, nutrition, sarcopenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 28 Feb 2018 (actual)
Primary completion: 1 Oct 2022 (actual)
Study completion: 1 Oct 2022 (actual)
First posted: 12 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: The investigator will conduct a patient-randomized, two-arm pilot study of 38 participants with a predicted attrition rate of 20% resulting in 30 total participants; n=10 in Arm 1 and n=20 in Arm 2. Arm 1 will serve as the control arm and Arm 2 will serve as the intervention arm.

Arm	Type	Receives
Arm 1 - Control Arm	Experimental	Device: Nokia GO Wearable StepTrackerUsual 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.
Arm 2 - Intervention arm	Experimental	Device: Nokia GO Wearable StepTracker, Other: Medication Reminder, Other: Weekly Check-in appointment with study team or providerPhysical 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.

Who may qualify

Ages: 21 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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;
Patient and physician feel that individual can safely participate in an exercise program;
Meeting at least one 'at risk' criterion for impaired physical performance, frailty, or malnutrition (by SPPB, abPG-SG, dynamometer measured grip strength), or physical deconditioning as determined by physical therapist, or treating clinician.

Key exclusion criteria (6 listed)

The patient is unable to provide informed consent;
The patient has been hospitalized within the last 30 days;
A score of 0-3 points on the SPPB assessment indicating inability to participate in a physical activity program or a score of 12 in the absence of frailty or malnutrition (indicating low risk for poor physical or performance or malnutrition);
The patient is at risk for falling as defined by clinician assessment results or if the patient states that he/she has a history of falling (record of a fall(s) in the past 30 days);
The patient is already enrolled in a financial incentive-based exercise program using a wearable device;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nokia GO Wearable StepTrackerAll participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.	Device	Arm 1 - Control Arm, Arm 2 - Intervention arm
Medication ReminderMedication reminders are sent to participants in Arm 2 on a daily basis.	Other	Arm 2 - Intervention arm
Weekly Check-in appointment with study team or providerVirtual meeting or telephone call between participants and study team to assess study involvement, adherence to procedures, and following of medical care recommendations.	Other	Arm 2 - Intervention arm

Primary outcome

Feasibility of the Intervention
Time frame: 14 weeks
Feasibility of the intervention will be evaluated by the percentage of patients that complete the study intervention.
Acceptability of the Intervention
Time frame: 14 weeks
Acceptability will be measured using a patient satisfaction questionnaire upon study completion.

4 secondary outcomes

Performance on the Short Physical Performance Battery (SPPB)
Time frame: 14 weeks
Grip strength
Time frame: 14 weeks
Grip strength level relative to BMI
Time frame: 14 weeks
Body composition/BIA
Time frame: 14 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the Intervention (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03584646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.