NCT04490148Completed
Remote Pulmonary Function Testing and Nurse Coaching in ALS
Remote Pulmonary Function Testing and Nurse Respiratory Health Coaching in Amyotrophic Lateral Sclerosis
Source: ClinicalTrials.gov · Last updated 24 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 22 Jul 2020
- Start date
- 1 Jul 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Milton S. Hershey Medical Center
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT04490148
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 1 Jul 2020 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive impairment, as judged by the ALS clinic neurologist, that prevents participation in the study.
- Caregivers: None
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hershey Medical Center ALS Clinic Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.