Non-invasive Ventilator Modems: a Qualitative Study

April 9, 2024 updated by: Stephanie Mansell, Royal Free Hospital NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Qualitaitve
Other: Qualitative
Focus group and 1:1 telephone interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focus groups, 1:1 telephone interviews
Time Frame: 18 months
Modified thematic analysis
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Free Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Stephanie Mansell, Royal Free London NHS FoundationTrust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9816 (Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated and/or analysed during the current study are not publicly available in order to maintain participant anonymity, but are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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