Non-invasive Ventilator Modems: a Qualitative Study

Ventilatory Failure Clinical Trial

Official title:

Exploring the Experiences and Views of Patients, Their Carers' and Health Care Providers on the Use of Modems in Managing Patients Receiving Domiciliary Non-invasive Ventilation (NIV): a Qualitative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905382
• Other study ID #: 9816
• Status: Completed
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2024
• Source: Royal Free Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Advances in technology has meant that domiciliary non-invasive (NIV) devices can be remotely monitored via modems in patients' homes. Possible benefits and challenges of modem technology have yet to be established. This study explored the perspectives and experiences of patients, their carers' and health care professionals (HCPs) on the addition of modem technology in managing home NIV patients.

Description:

The aim of this study is to consider the opinions of patients, their carers' and health care providers on the addition of using modem technology in the management of patients with hypercapnic respiratory failure receiving domiciliary NIV.

Objectives

1. To investigate the experience of patients receiving domiciliary NIV with modem technology and how this compares to NIV treatment without a modem

2. To investigate the experience of carers' of patients receiving domiciliary NIV with modem technology and how this compares to NIV treatment without a modem

3. To gain opinions of health care providers on the use of modem technology in caring for patient with ventilatory failure and how this compares to delivering home NIV treatment without a modem 4.2 Outcome The outcome of this study will inform future service development of home NIV services to ensure they are designed with service users' preferences in mind.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients and carers •Patients and their carers who received treatment from the Royal Free London (RFL) domiciliary NIV service both pre and post modem installation will be eligible to be included in the study.

HCPs

•Staff who have experience of looking after patients with NIV both with and without modems will be able to take part in the study. Staff recruited will be currently working at RFL. We have been using modems for all of our patients with NIV since December 2014. Therefore rotational staff (e.g. registrars) working RFL will only have experience of looking after patients with modems on their NIV. To allow for this factor staff will be allowed to join the study even if their experience of looking after patients with NIV without modems is at other hospitals.

Exclusion Criteria:

• Patients under the care of the RFL domiciliary NIV service who have only had experience of treatment with a modem in situ will be excluded from the study.

• Patients who are unable to verbally communicate

• Patients who cannot have an "everyday" level conversation in English

Related Conditions & MeSH terms

• Hypoventilation
• Ventilatory Failure

Intervention

Other:
• Qualitative
Focus group and 1:1 telephone interviews

Locations

Country	Name	City	State
United Kingdom	Royal Free London NHS foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Free Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Mansell SK, Kilbride C, Wood MJ, Gowing F, Mandal S. Experiences and views of patients, carers and healthcare professionals on using modems in domiciliary non-invasive ventilation (NIV): a qualitative study. BMJ Open Respir Res. 2020 Mar;7(1):e000510. doi: 10.1136/bmjresp-2019-000510. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Focus groups, 1:1 telephone interviews	Modified thematic analysis	18 months