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.Study Status:
Recruiting
Disease:
ALS
Study Type:
Interventional
Type of Intervention:
Device, Behavioral
Intervention Name:
remote pulmonary function testing, standard pulmonary function testing, Nurse Respiratory Health Coaching (NRHC)
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Hershey Medical Center ALS Clinic
Andrew Geronimo, PhD / email hidden; JavaScript is required / 717-531-0003
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
Estimated Enrollment:
40
Estimated Study Start Date:
07 / 01 / 2020
Estimated Study Completion Date:
06 / 30 / 2024
Posting Last Modified Date:
03 / 23 / 2023
Date Study Added to neals.org:
07 / 28 / 2020
Minimum Age:
18 Years
Maximum Age:
N/A
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
Hershey Medical Center ALS Clinic | Recruiting
Andrew Geronimo, PhD / 717-531-0003 Ext. 282576 / email hidden; JavaScript is required
Hershey, Pennsylvania
17033
United States