Ventilatory FailureNCT03905382
Non-invasive Ventilator Modems: a Qualitative Study
A study testing Qualitative in people with Ventilatory Failure, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilatory Failure
- What is being tested?
- Qualitative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Free London NHS foundation Trust
London, NW3 2QG
About this 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
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.
Read the 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.
- Conditions
- Ventilatory Failure
- Being tested
- Qualitative
- Keywords
- Technology, Modems, Qualitative Research
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QualitativeOther
Focus group and 1:1 telephone interviews
| Study group | Role | What they receive |
|---|---|---|
| Qualitaitve | Other | Qualitaitve Receives: Other: Qualitative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focus groups, 1:1 telephone interviews
Modified thematic analysis
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start18 Jul 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilatory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Mansell, Royal Free Hospital NHS Foundation Trust
- Investigators
- Stephanie Mansell, Principal investigator, Royal Free London NHS FoundationTrust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905382
- Sponsor's protocol ID
- 9816
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2019
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32161065
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03905382
- Acronym / sponsor ID
- 9816
- Conditions
- Ventilatory Failure
- Keywords
- Technology, Modems, Qualitative Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group
| Arm | Type | Receives |
|---|---|---|
| Qualitaitve | Other | Other: QualitativeQualitaitve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QualitativeFocus group and 1:1 telephone interviews | Other | Qualitaitve |
Primary outcome
Focus groups, 1:1 telephone interviews
Time frame: 18 months
Modified thematic analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 32161065Mansell 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Ventilatory Failure
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
HFNC Versus NIV in Hypercapneic COPD Patients
COPD (Chronic Obstructive Pulmonary Disease)
Recruiting
Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma
Multiple Myeloma (MM), Breathing Techniques
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Mansell principal investigator
Royal Free London NHS FoundationTrust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative in people with Ventilatory Failure, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focus groups, 1:1 telephone interviews (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03905382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.