Back to resultsNon-invasive Ventilator Modems: a Qualitative Study
Primary Purpose
Ventilatory Failure
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Qualitative
Sponsored by
About this trial
This is an interventional other trial for Ventilatory Failure focused on measuring Technology, Modems, Qualitative Research
Eligibility Criteria
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
Sites / Locations
- Royal Free London NHS foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Qualitaitve
Arm Description
Qualitaitve
Outcomes
Primary Outcome Measures
Focus groups, 1:1 telephone interviews
Modified thematic analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT03905382
First Posted
April 3, 2019
Last Updated
May 24, 2021
Sponsor
Royal Free Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03905382
Brief Title
Non-invasive Ventilator Modems: a Qualitative Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Free Hospital NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
To investigate the experience of patients receiving domiciliary NIV with modem technology and how this compares to NIV treatment without a modem
To investigate the experience of carers' of patients receiving domiciliary NIV with modem technology and how this compares to NIV treatment without a modem
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilatory Failure
Keywords
Technology, Modems, Qualitative Research
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Qualitaitve
Arm Type
Other
Arm Description
Qualitaitve
Intervention Type
Other
Intervention Name(s)
Qualitative
Intervention Description
Focus group and 1:1 telephone interviews
Primary Outcome Measure Information:
Title
Focus groups, 1:1 telephone interviews
Description
Modified thematic analysis
Time Frame
18 months
10. Eligibility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Mansell
Organizational Affiliation
Royal Free London NHS FoundationTrust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Free London NHS foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
32161065
Citation
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.
Results Reference
background
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Non-invasive Ventilator Modems: a Qualitative Study
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