Remote Pulmonary Function Testing and Nurse Coaching in ALS

Brief Title

Remote Pulmonary Function Testing and Nurse Coaching in ALS

Official Title

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

Brief 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.
    

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

Interventional


Primary Outcome

Date of identification of noninvasive ventilation (NIV) need from rPFT monitoring

Secondary Outcome

 Respiratory-related quality of life

Condition

ALS

Intervention

remote pulmonary function testing

Study Arms / Comparison Groups

 remote PFT (rPFT) longitudinal
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

40

Start Date

July 1, 2020

Completion Date

December 31, 2022

Primary Completion Date

June 30, 2022

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 717-531-0003, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04490148

Organization ID

STUDY00006924part2


Responsible Party

Principal Investigator

Study Sponsor

Milton S. Hershey Medical Center

Collaborators

 ALS Association

Study Sponsor

, , 


Verification Date

July 2020