NCT03905382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 3, 2019

Last Update Submit

April 9, 2024

Conditions

Keywords

TechnologyModemsQualitative Research

Outcome Measures

Primary Outcomes (1)

  • Focus groups, 1:1 telephone interviews

    Modified thematic analysis

    18 months

Study Arms (1)

Qualitaitve

OTHER

Qualitaitve

Other: Qualitative

Interventions

Focus group and 1:1 telephone interviews

Qualitaitve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free London NHS foundation Trust

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32161065BACKGROUND

MeSH Terms

Conditions

Hypoventilation

Interventions

Evaluation Studies as Topic

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Stephanie Mansell

    Royal Free London NHS FoundationTrust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Physiotherapist

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 5, 2019

Study Start

July 18, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

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.

Locations