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Non-invasive Ventilator Modems: a Qualitative Study

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ClinicalTrials.gov Identifier: NCT03905382
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie Mansell, Royal Free Hospital NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Ventilatory Failure Other: Qualitative Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : July 18, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Qualitaitve
Qualitaitve
Other: Qualitative
Focus group and 1:1 telephone interviews




Primary Outcome Measures :
  1. Focus groups, 1:1 telephone interviews [ Time Frame: 18 months ]
    Modified thematic analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905382


Locations
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United Kingdom
Royal Free London NHS foundation Trust
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Royal Free Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Stephanie Mansell Royal Free London NHS FoundationTrust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stephanie Mansell, Consultant Physiotherapist, Royal Free Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03905382    
Other Study ID Numbers: 9816
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie Mansell, Royal Free Hospital NHS Foundation Trust:
Technology
Modems
Qualitative Research
Additional relevant MeSH terms:
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Hypoventilation
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory