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Remote Pulmonary Function Testing and Nurse Coaching in ALS

NCT04490148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-07-24

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • ALS Association

    collaborator OTHER

  • Milton S. Hershey Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-12-31
Completion
2024-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04490148 on ClinicalTrials.gov