Barriers and Facilitators of Key Stakeholders to Implemen... | NCT05321004

Studies
Barriers and Facilitators of Key Stakeholders to Implement Remote Monitoring Technologies: a Mixed-methods Analysis

NCT05321004

Sponsor

Imperial College London

Status

Completed

Last Update Posted

Apr 10, 2024Actual

Enrollment

18Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Semi-structured interviews will be conducted - there will be no intervention.

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Aug 1, 2023Actual

Completion Date

Aug 1, 2023Actual

First Submitted Date

Mar 29, 2022

First Submission Date that Met QC Criteria

Apr 8, 2022

First Posted Date

Apr 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2024

Last Update Posted Date

Apr 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Advancements in digital technologies alongside the global pandemic of COVID-19 have accelerated the adoption of novel healthcare pathways worldwide, with healthcare delivery transitioning beyond the traditional face-to-face model. Telemedicine has gained long over- due exposure during a complicated crisis; as the number of cases continue to grow with second waves predicted, digital modalities have become critical in moderating exposure risk to healthcare staff, reducing community spread, and delivering quality healthcare remotely for exposed or infected individuals.

Remote monitoring solutions are being established internationally to allow individuals to continue living at home rather than in expensive hospital facilities using non-invasive digital technologies (such as wearable sensors) to collect health data, support health provider assessment and clinical decision making.

With the advances in technology miniaturisation, sensors have become increasingly portable, unobtrusive, lightweight, and waterproof, offering an emerging solution to continuous remote monitoring of vital signs. It is predicated that continuous monitoring allows for early recognition of clinical deterioration, and through digital alerting, offers an opportunity for earlier clinical intervention, improving patient care and patient outcomes.

Within the United Kingdom (UK), widespread digital transformations are facilitated by NHS digital, a non-departmental public body created by statute, delivering large health informatics programmes. As such, this study aims to investigate key stakeholder perspectives on an organisational level of implementing remote monitoring solutions, given the pandemic, in the National Health Service (NHS), identifying factors that could affect successful execution and adoption.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semi-structured interviews will be conducted - there will be no intervention.	Other	The use of semi structured interviews and questionnaires

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validated TAM (technology acceptance model) questionnaire	Liberty scale questionnaire responses	1 year
Thematic analysis	Semi structured interviews using a predetermined topic guide on questions relating to barriers and facilitators	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A mixed methods approach will be implemented: semi-structured interviews will be conducted with high level stake holders from industry, academia, and healthcare providers who have played an instrumental role with prior experience of implementing digital solutions.

Exclusion Criteria:

not able to provide informed consent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Previous experience in implementing remote monitoring solutions

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imperial College London		London			United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37338929	Derived	Iqbal FM, Aggarwal R, Joshi M, King D, Martin G, Khan S, Wright M, Ashrafian H, Darzi A. Barriers to and Facilitators of Key Stakeholders Influencing Successful Digital Implementation of Remote Monitoring Solutions: Mixed Methods Analysis. JMIR Hum Factors. 2024 May 6;11:e49769. doi: 10.2196/49769.
35862185	Derived

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections