Remote Pulmonary Function Testing and Nurse Coaching in ALS

NCT ID: NCT04490148

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2024-06-30

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.

Conditions

ALS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

remote pulmonary function testing

Intervention Type: DEVICE

Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

standard pulmonary function testing

Intervention Type: DEVICE

Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

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.

Group Type: EXPERIMENTAL

remote pulmonary function testing

Intervention Type: DEVICE

Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

standard pulmonary function testing

Intervention Type: DEVICE

Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

Nurse Respiratory Health Coaching (NRHC)

Intervention Type: BEHAVIORAL

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.

Interventions

remote pulmonary function testing

Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

Intervention Type: DEVICE

standard pulmonary function testing

Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALS Association

OTHER

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Zachary Simmons, MD

Professor of Neurology and Humanities

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hershey Medical Center ALS Clinic

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00006924part2

Identifier Type: -

Identifier Source: org_study_id