Remote Pulmonary Function Testing and Nurse Coaching in ALS

July 15, 2024 updated by: Zachary Simmons, MD, Milton S. Hershey Medical Center

Remote Pulmonary Function Testing and Nurse Respiratory Health Coaching in Amyotrophic Lateral Sclerosis

Comparison of respiratory outcomes in patients receiving telemedicine-guided remote pulmonary function testing (rPFT) with or without the additional support of nurse coaching. This is a randomized controlled study which assesses the effects rPFT and coaching on respiratory outcomes and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a two-arm, randomized study to determine 1) whether weekly monitoring of respiratory function can lead to timelier initiation of NIV and 2) whether structured nurse coaching leads to improved self-efficacy for managing disease and better maintenance of respiratory health. For enrollees in both arms, standard FVC and MIP measurements obtained approximately every three months by the respiratory therapist during ALS Clinic are supplemented with self-administered rPFTs performed weekly. Enrollees in the rPFT+NRHC (nurse respiratory health coaching) arm will additionally receive monthly coaching with the study nurse via telehealth. Outcomes include measures of quality of life and self-efficacy for managing disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Andrew Geronimo, PhD
  • Phone Number: 282576 717-531-0003
  • Email: geronimo@psu.edu

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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
  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).

Caregivers:

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

Exclusion Criteria:

Patients:

  1. Use of NIV or diaphragm pacer at time of obtaining informed consent.
  2. FVC ≤50% predicted or MIP > -60 cm of water.
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: remote PFT (rPFT) longitudinal
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.
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)
Experimental: remote PFT (rPFT) + Nurse Coaching longitudinal
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.
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)
Behavioral: Nurse Respiratory Health Coaching (NRHC)
Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. [Bennett2010], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Date of Identification of Noninvasive Ventilation (NIV) Need From rPFT Monitoring
Time Frame: 1 year
NIV is typically prescribed when an individual demonstrates signs of respiratory failure. In this study, forced vital capacity (FVC) of 50% or less of the predicted value serves as a surrogate for respiratory failure and constitutes identification of NIV need. First date of remote measurement of FVC 50% or less of the predicted value is reported here.
1 year
Date of Identification of NIV Need From Standard PFT Monitoring
Time Frame: From date of enrollment until first identification of non-invasive ventilation need, assessed up to 1.5 years
NIV is typically prescribed when an individual demonstrates signs of respiratory failure. In this study, forced vital capacity (FVC) of 50% or less of the predicted value serves as a surrogate for respiratory failure and constitutes identification of NIV need. First date of standard, in-clinic measurement of FVC 50% or less of the predicted value is reported here.
From date of enrollment until first identification of non-invasive ventilation need, assessed up to 1.5 years
Self-efficacy for Managing Medications and Treatments
Time Frame: 1 year
The self-efficacy assessment contains questions from the Patient-Reported Outcomes Measurement Information System (PROMIS) item banks on Self-Efficacy for Managing Medications and Treatments (4 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.
1 year
Self-efficacy for Managing Social Interactions
Time Frame: 1 year
The self-efficacy assessment contains questions from the PROMIS item bank on Self-Efficacy for Managing Social Interactions (5 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.
1 year
Self-efficacy for Managing Symptoms
Time Frame: 1 year
The self-efficacy assessment contains questions from the PROMIS item bank on Self-Efficacy for Managing Symptoms (9 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
rPFT Adherence
Time Frame: 1 year
Participant adherence to rPFT protocol, defined as the percentage of eligible weeks with a submitted rPFT report.
1 year
Dyspnea Characteristics
Time Frame: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS) Pool v1.0 - Dyspnea Characteristics (5 items), which uses Likert-type scaling that are summed to a total score. Participants complete this questionnaire each month (12 total administrations). Total score range 0-44, with higher numbers indicating more severe dyspnea. The reported value is the slope of regression of total score on time, in point change per month.
1 year
Respiratory-related Symptoms
Time Frame: 1 year
Subjects were asked to report whether they experienced the following symptoms in the past month during each month on the study (12 administrations): excessive secretions, drooling, choking on secretions, morning headache. Reported value is the sum of experienced symptoms (0-4) summed over 12 months. Participants could experience none of these symptoms (0) up to experiencing all symptoms each month (48).
1 year
Dyspnea Functional Limitations
Time Frame: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Dyspnea Functional Limitations - Short Form 10a (10 items), which uses Likert-type scaling that are summed to a total score. Participants complete this questionnaire each month (12 total administrations). Total score range 0-30, with higher numbers indicating more functional limitations due to dyspnea. The reported value is the slope of regression of total score on time, in point change per month.
1 year
Sleep Related Impairment
Time Frame: 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Sleep Related Impairment - Short Form 8a (8 items), which uses Likert-type scaling that are summed to a total score. Participants complete this questionnaire each month (12 total administrations). Total score range 8-40, with higher numbers indicating more sleep-related impairment. The reported value is the slope of regression of total score on time, in point change per month.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ALS Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00006924part2

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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