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Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)

Primary Purpose

ALS

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

remote pulmonary function testing

standard pulmonary function testing

About this trial

This is an interventional health services research trial for ALS focused on measuring Telemedicine, Pulmonary Function Testing, Telehealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

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:

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

Sites / Locations

Hershey Medical Center ALS Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

remote PFT (rPFT) validation

Arm Description

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

Outcomes

Primary Outcome Measures

Standard PFT - Forced Vital Capacity

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

Standard PFT - Maximal Inspiratory Pressure

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

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.

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.

Secondary Outcome Measures

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)]

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)]

Full Information

NCT ID

NCT03214224

First Posted

June 30, 2017

Last Updated

July 22, 2020

Sponsor

Milton S. Hershey Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03214224

Brief Title

Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)

Official Title

Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ALS

Keywords

Telemedicine, Pulmonary Function Testing, Telehealth

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

remote PFT (rPFT) validation

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

remote pulmonary function testing

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

standard pulmonary function testing

Intervention Description

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

Primary Outcome Measure Information:

Title

Standard PFT - Forced Vital Capacity

Description

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

Time Frame

One administration - 10 minutes

Title

Standard PFT - Maximal Inspiratory Pressure

Description

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

Time Frame

One administration - 10 minutes

Title

Remote PFT - Forced Vital Capacity

Description

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.

Time Frame

One administration - 10 minutes

Title

Remote PFT - Maximal Inspiratory Pressure

Description

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.

Time Frame

One administration - 10 minutes

Secondary Outcome Measure Information:

Title

Patient and Caregiver Reported Outcomes

Description

Time Frame

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

Title

Therapist Reported Outcomes

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). 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: 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

Facility Information:

Facility Name

Hershey Medical Center ALS Clinic

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan at this time to share data with other researchers

Learn more about this trial

Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)

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