Non-invasive Ventilator Modems: a Qualitative Study

NCT ID: NCT03905382

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ventilatory Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Qualitaitve

Qualitaitve

Group Type OTHER

Qualitative

Intervention Type OTHER

Focus group and 1:1 telephone interviews

Interventions

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Qualitative

Focus group and 1:1 telephone interviews

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Stephanie Mansell

Consultant Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephanie Mansell

Role: PRINCIPAL_INVESTIGATOR

Royal Free London NHS FoundationTrust

Locations

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Royal Free London NHS foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 32161065 (View on PubMed)

Other Identifiers

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9816

Identifier Type: -

Identifier Source: org_study_id

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