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Remote Pulmonary Function Testing + Nurse Coaching for Lou Gehrig's Disease
N/A
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 years of age or older.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial compares the effects of telemedicine-guided remote pulmonary function testing with or without nurse coaching on respiratory outcomes and quality of life.
Who is the study for?
This trial is for adults over 18 with ALS, diagnosed as per El Escorial criteria, who have had symptoms start within the last three years. Participants need a caregiver, home internet, and a second device for an app. Those unable to consent or without the necessary technology cannot join.Check my eligibility
What is being tested?
The study compares remote pulmonary function testing (rPFT) alone versus rPFT combined with Nurse Respiratory Health Coaching (NRHC). It's randomized and checks how these affect breathing outcomes and life quality in ALS patients.See study design
What are the potential side effects?
Since this trial involves non-invasive testing and coaching rather than medication, typical drug side effects are not expected. However, participants may experience fatigue or discomfort from frequent testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Date of identification of NIV need from standard PFT monitoring
Date of identification of noninvasive ventilation (NIV) need from rPFT monitoring
Self-efficacy
Secondary outcome measures
Respiratory-related medical complications
Respiratory-related quality of life
rPFT Adherence
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: remote PFT (rPFT) + Nurse Coaching longitudinalExperimental Treatment3 Interventions
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
Group II: remote PFT (rPFT) longitudinalActive Control2 Interventions
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
remote pulmonary function testing
2017
N/A
~50
standard pulmonary function testing
2017
N/A
~50
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
494 Previous Clinical Trials
2,798,802 Total Patients Enrolled
ALS AssociationOTHER
42 Previous Clinical Trials
16,559 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You understand and agree to participate in the study.You have a working computer and internet connection at home to participate in online medical appointments.You have a second device like a smartphone or tablet that can download the spirometer application from the app store.You have someone available to help you with the study.You have been diagnosed with ALS according to specific research criteria.My symptoms started less than 3 years ago.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: remote PFT (rPFT) longitudinal
- Group 2: remote PFT (rPFT) + Nurse Coaching longitudinal
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots available for this clinical trial?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, first posted on July 1st 2020 and recently updated on the 12th of July 2022, is actively recruiting patients for participation across one location with a target recruitment number of 40 individuals."
Answered by AI
What is the sample size of this investigation?
"Affirmative, clinicaltrials.gov confirms that recruitment for this study is ongoing; the trial was first advertised on July 1st 2020 and has since been updated. 40 participants are required from one medical center."
Answered by AI
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