Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)

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.

Study Overview

• Status: Completed
• Conditions: ALS
• Intervention / Treatment: Device: remote pulmonary function testing; Device: standard pulmonary function testing

Detailed Description

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. The central hypothesis is that guided home assessment of respiratory function is a valid method for detecting respiratory insufficiency leading to noninvasive ventilation (NIV) recommendation. This study has the potential to transform the current practice of conducting breathing assessments every three months, resulting in timelier detection of respiratory insufficiency, thereby staining quality of life and lengthening survival. This protocol has the potential to demonstrate telemanagement exceeding the standards of ALS care.

This is a self-controlled study which will enroll 40 patients from the ALS clinic. On the day of their clinical visit, study participants will perform both a standard PFT as well as a simulated rPFT, both generating three valid repetitions of forced vital capacity (FVC) and maximal inspiratory pressure (MIP) procedures. The simulated rPFT will mimic the practice of home telemonitoring by having patients be instructed by a respiratory therapist over the telemanagement portal while in a research room within the ALS clinic. The primary hypothesis is that there is no difference in the results of PFT and rPFT for respiratory assessment of FVC and MIP.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Hershey Medical Center ALS Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Part 1

Patients:

1. Possess a diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria [Brooks2000].
2. Be 18 years of age or older.
3. Have a caregiver available to participate in the study

Caregivers:

1. Be 18 years of age or older, of either gender.
2. Be able and willing to provide informed consent.

Respiratory Therapist

1. Be a member of the Hershey Medical Center ALS multidisciplinary care team.
2. Be able and willing to provide verbal informed consent after receiving a summary explanation of research (SER).

Part 2 imposes additional inclusion criteria for patients only.

Patients:

4) Symptom onset within the last three years. 5) Have a computer and home internet service sufficient for engaging in telemedicine sessions.

6) Have a second device capable of downloading the spirometer application from an app store (Android- or iOS-based smartphone or tablet).

Exclusion Criteria:

• Exclusion criteria are the same for both parts of the study.

Patients:

1. Use of NIV or diaphragm pacer at time of obtaining informed consent.
2. FVC ≤50% predicted or MIP > -60 cm H2O.
3. 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.
4. Cognitive impairment, as judged by the ALS clinic neurologist, that prevents participation in the study.

Caregivers: None

Respiratory Therapists: None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: remote PFT (rPFT) validation; Subjects in this arm perform both standard and remote PFT assessments in order to validate the procedure.	Device: remote pulmonary function testing; Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP); Device: standard pulmonary function testing; Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and Caregiver Reported Outcomes	Survey responses from the patient/caregiver pair. Likert-type scales are used to generate subscores pertaining to: General Acceptability, Forced Vital Capacity Acceptability, and Maximal Inspiratory Pressure Acceptability. Subscales (evaluated separately): General Acceptability [0-5 (worst-best)] Forced Vital Capacity Acceptability [0-5 (worst-best) Maximal Inspiratory Pressure Acceptability [0-5 (worst-best)]	10 minute survey administered following completion of standard and remote PFT of Part 1
Therapist Reported Outcomes	Survey responses from the respiratory therapist. Likert-type scales are used to generate subscores pertaining to: General Acceptability, Forced Vital Capacity Acceptability, and Maximal Inspiratory Pressure Acceptability. Subscales (evaluated separately): General Acceptability [0-5 (worst-best)] Forced Vital Capacity Acceptability [0-5 (worst-best) Maximal Inspiratory Pressure Acceptability [0-5 (worst-best)]	10 minute survey administered following completion of standard and remote PFT of Part 1

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (ACTUAL): July 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Telemedicine; Telehealth; Pulmonary Function Testing
• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: STUDY00006924part1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan at this time to share data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No