Remote Pulmonary Function Testing and Nurse Coaching in ALS

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Milton S. Hershey Medical Center
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Updated on 5 August 2020
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pulmonary function test

Summary

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.

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.

Details
Condition Amyotrophic Lateral Sclerosis, Antilymphocyte Serum
Age 18years - 100years
Treatment remote pulmonary function testing, standard pulmonary function testing, Nurse Respiratory Health Coaching (NRHC)
Clinical Study IdentifierNCT04490148
SponsorMilton S. Hershey Medical Center
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
Symptom onset within the last three years
Have a computer and home internet service sufficient for engaging in telemedicine sessions
Have a second device capable of downloading the spirometer application from an app store (Android- or iOS-based smartphone or tablet)
Caregivers
Be 18 years of age or older, of either gender
Be able and willing to provide informed consent

Exclusion Criteria

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