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Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03214224
Recruitment Status : Completed
First Posted : July 11, 2017
Results First Posted : April 9, 2019
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Zachary Simmons, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
ALS Device: remote pulmonary function testing Device: standard pulmonary function testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A self-controlled validation study of experimental remote PFT assessment vs standard of care (non-randomized)
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019


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)




Primary Outcome Measures :
  1. Standard PFT - Forced Vital Capacity [ Time Frame: One administration - 10 minutes ]
    Respiratory therapist will administer three valid maneuvers of forced vital capacity (FVC) The best FVC value is the outcome.

  2. Standard PFT - Maximal Inspiratory Pressure [ Time Frame: One administration - 10 minutes ]
    Respiratory therapist will administer three valid maneuvers of maximal inspiratory pressure (MIP). The best MIP value is the outcome.

  3. Remote PFT - Forced Vital Capacity [ Time Frame: One administration - 10 minutes ]
    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.

  4. Remote PFT - Maximal Inspiratory Pressure [ Time Frame: One administration - 10 minutes ]
    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 :
  1. Patient and Caregiver Reported Outcomes [ Time Frame: 10 minute survey administered following completion of standard and remote PFT of Part 1 ]

    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)]


  2. Therapist Reported Outcomes [ Time Frame: 10 minute survey administered following completion of standard and remote PFT of Part 1 ]

    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)]




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214224


Locations
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United States, Pennsylvania
Hershey Medical Center ALS Clinic
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
  Study Documents (Full-Text)

Documents provided by Zachary Simmons, Milton S. Hershey Medical Center:
Informed Consent Form  [PDF] April 17, 2018

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Responsible Party: Zachary Simmons, Professor of Neurology and Humanities, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03214224    
Other Study ID Numbers: STUDY00006924part1
First Posted: July 11, 2017    Key Record Dates
Results First Posted: April 9, 2019
Last Update Posted: August 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan at this time to share data with other researchers

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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
Keywords provided by Zachary Simmons, Milton S. Hershey Medical Center:
Telemedicine
Pulmonary Function Testing
Telehealth
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases