Home Airway Clearance in Patients With Bronchiectasis (Home-Care Bronchiectasis)

NCT04742270 | Completed

• 1 other identifier: 2020-03
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

Bronchiectasis is a chronic multiple etiologies pulmonary disease characterized by permanent dilatation of the caliber of the bronchial tree territory with an alteration of mucociliary clearance. This alteration causes mucus retention and leads to infections and chronic bronchial inflammation. Respiratory physiotherapy is one of the cornerstones of the management of these patients, particularly to facilitate bronchial drainage. In patients with abundant bronchial secretions, it is recommended to carry out airway clearance sessions daily or several times a day, which represents a very significant burden of care. Moreover, access to respiratory physiotherapy care isn't always easy for patients due to geographical, time, or professional availability limitations. In addition, few professionals are trained in France for this specific care dedicated to chronic lung disease. Finally with this kind of remote formation and follow up, it may be more suitable for this at-risk patient population in the context of the COVID-19 pandemic situation (limitation of physical contact). SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device (CE medical mark) for bronchial tree drainage. The use of this device in autonomy by the patient requires however a specific initial training of a few sessions (3-5 sessions). Tele-physiotherapy could allow remote training of patients in the use of SIMEOX®. This SIMEOX® device used autonomously at home, could provide patients with a practical and efficient bronchial clearance technique. The overall objective of this pilot study is to evaluate the use of SIMEOX® at home after education in its use by telecare for bronchial drainage in patients with bronchiectasis (non-cystic Fibrosis Bronchiectasis) and who have difficulty accessing usual respiratory physiotherapy sessions.

Conditions

Bronchiectasis Adult

Keywords

Airway Clearance; Bronchiectasis; Respiratory Physiotherapy Telecare

Outcome Measures

Primary Outcomes (1)

• Compliance

  The compliance with the SIMEOX® device at home is assessed by the change in the percentage of patient with an average of at least 3 sessions/week between D15 and 3 months (self-reported compliance by the patient on a diary)

  3 months after inclusion

Secondary Outcomes (20)

• Compliance reliability

  3 months after inclusion

• Device use

  3 months after inclusion

• Device satisfaction

  3 months after inclusion

• General compliance

  At inclusion

• Link between compliance to treatment and Physical activity

  At inclusion and 3 months after

Study Arms (1)

SIMEOX+ respiratory physiotherapy telecare

EXPERIMENTAL

Use the device for 3 months in addition to usual care

Device: SIMEOX+ respiratory physiotherapy telecare

Interventions

SIMEOX+ respiratory physiotherapy telecare DEVICE

Every 10 days, the patient's expert physiotherapist will contact the patient by video-transmission or telephone call for motivational reinforcement and technical support in the use of the device. During these phone calls, a quick 3-question questionnaire will be administered to the patient to monitor events of hemoptysis, chest pain and clinical symptoms of gastroesophageal reflux disease: pyrosis.If patients report this type of event, the physiotherapist will inform the patient's physician for management at his/her discretion. The expert physiotherapist will also conduct this sessions in order to increase the patient's motivation and compliance to the device. In order to do this, he will identify (in collaboration with the patient), the patient's difficulties and obstacles and he will try to find solutions with him.

SIMEOX+ respiratory physiotherapy telecare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a diagnosis of bronchiectasis confirmed by HR CT scan, regardless of etiology except cystic fibrosis and with estimated bronchorrhea \>10mL/d.
• Disease stability, defined as a delay of at least 4 weeks since the end of an exacerbation (end of antibiotic therapy or judged as resolved by the investigator).
• Age \> 18 years old
• Patient does not have access to a physiotherapist or does not usually go to a physiotherapy office (\<1/week on average)

You may not qualify if:

• Patient on transplant list
• Any contraindication to an instrumental bronchial clearance technique (at the discretion of the investigator)
• Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman (verified by the dosage of β-HCG for any woman wishing to participate in the protocol and of childbearing age \< 60 years), parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)

Sponsors & Collaborators

• Physio-Assist: lead
• Icadom: collaborator

Study Sites (3)

Grenoble University-Affiliated Hospital : Pneumology department

Grenoble, 38043, France

Location

Nice university-affiliated hospital : pneumonoly department

Nice, 06001, France

Location

Toulouse University-Affiliated Hospital : Pneumology department

Toulouse, 31030, France

Location

Related Publications (1)

• Hamidfar R, Murris-Espin M, Mahot M, Abouly R, Gauchez H, Jacques S, Joffray E, Arnol N, Morin L, Leroy S, Borel JC. Feasibility of home initiation of an airway clearance device (SIMEOX) by telecare in people with non-cystic fibrosis bronchiectasis: a pilot study. BMJ Open Respir Res. 2023 Jul;10(1):e001722. doi: 10.1136/bmjresp-2023-001722.

  PMID: 37524523 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Rebecca Hamidfar, MD

  Grenoble university affiliated hospital : pneumology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Non applicable
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There is no comparison procedure included in this feasibility trial. Patients will be their own control.

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 8, 2021
• Study Start: March 4, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)