Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)

NCT03214224 | Completed Results FDA Device

• 1 other identifier: STUDY00006924part1
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The specific objective of this study is to validate the practice of remote pulmonary function testing (rPFT) conducted in the home through the use of connected mobile health devices and the Penn State Hershey ALS Telemanagement program.

Conditions

ALS

Keywords

Telemedicine; Pulmonary Function Testing; Telehealth

Outcome Measures

Primary Outcomes (4)

• Standard PFT - Forced Vital Capacity

  Respiratory therapist will administer three valid maneuvers of forced vital capacity (FVC) The best FVC value is the outcome.

  One administration - 10 minutes

• Standard PFT - Maximal Inspiratory Pressure

  Respiratory therapist will administer three valid maneuvers of maximal inspiratory pressure (MIP). The best MIP value is the outcome.

  One administration - 10 minutes

• Remote PFT - Forced Vital Capacity

  Respiratory therapist will use the telehealth interface to guide the patient and caregiver to self-administer three valid FVC maneuvers. The best FVC value is the outcome.

  One administration - 10 minutes

• Remote PFT - Maximal Inspiratory Pressure

  Respiratory therapist will use the telehealth interface to guide the patient and caregiver to self-administer three valid MIP maneuvers. The best MIP value is the outcome.

  One administration - 10 minutes

Secondary Outcomes (2)

• Patient and Caregiver Reported Outcomes

  10 minute survey administered following completion of standard and remote PFT of Part 1

• Therapist Reported Outcomes

  10 minute survey administered following completion of standard and remote PFT of Part 1

Study Arms (1)

remote PFT (rPFT) validation

EXPERIMENTAL

Subjects in this arm perform both standard and remote PFT assessments in order to validate the procedure.

Device: remote pulmonary function testing; Device: standard pulmonary function testing

Interventions

remote pulmonary function testing DEVICE

Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

remote PFT (rPFT) validation

standard pulmonary function testing DEVICE

Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

remote PFT (rPFT) validation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1
• Patients:
• Possess a diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria \[Brooks2000\].
• Be 18 years of age or older.
• Have a caregiver available to participate in the study
• Caregivers:
• Be 18 years of age or older, of either gender.
• Be able and willing to provide informed consent.
• Respiratory Therapist
• Be a member of the Hershey Medical Center ALS multidisciplinary care team.
• Be able and willing to provide verbal informed consent after receiving a summary explanation of research (SER).
• Patients:
• \) Symptom onset within the last three years. 5) Have a computer and home internet service sufficient for engaging in telemedicine sessions.
• \) Have a second device capable of downloading the spirometer application from an app store (Android- or iOS-based smartphone or tablet).

You may not qualify if:

• Patients:
• Use of NIV or diaphragm pacer at time of obtaining informed consent.
• FVC ≤50% predicted or MIP \> -60 cm H2O.
• ALS Functional Rating Scale (ALSFRS-R) \[Cedarbaum1999\] score on day of screening of ≥2 on items for speech, swallowing, and salivation. These items are indicators of bulbar dysfunction, which limits the reliability of PFT administration.
• Cognitive impairment, as judged by the ALS clinic neurologist, that prevents participation in the study.
• Caregivers: None
• Respiratory Therapists: None

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Hershey Medical Center ALS Clinic

Hershey, Pennsylvania, 17033, United States

Location

Results Point of Contact

• Title: Andrew Geronimo
• Organization: Penn State College of Medicine

geronimo@psu.edu

717-531-0003

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and Humanities

Model Details: A self-controlled validation study of experimental remote PFT assessment vs standard of care (non-randomized)

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 11, 2017
• Study Start: November 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 7, 2020
• Results First Posted: April 9, 2019

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)