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

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT04490148

Neals Affiliated?

No

Coordinating Center Contact Information

Hershey Medical Center ALS Clinic
Andrew Geronimo, PhD / .(JavaScript must be enabled to view this email address) / 717-531-0003 ext 282576
Anne Haulman, MPH / .(JavaScript must be enabled to view this email address) / 717-531-0003 ext 289123
Hershey, Pennsylvania 17033 United States

Full Study Summary:

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 Sponsor:

Milton S. Hershey Medical Center

Participant Duration:

Estimated Enrollment:

40

Estimated Study Start Date:

07/01/2020

Estimated Study Completion Date:

12/31/2022

Posting Last Modified Date:

09/28/2020

Date Study Added to alsconsortium.org:

09/28/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Min Vital Capacity (% predicted normal):

    50

    Time since Symptom Onset:

    >36 months

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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

  • Site Contact Information

    Hershey Medical Center ALS Clinic
    Andrew Geronimo, PhD / .(JavaScript must be enabled to view this email address) / 717-531-0003 ext 282576
    Hershey, Pennsylvania 17033
    United States