NCT05941182

Brief Summary

This study aims to involve the public, patients and National Health Service (NHS) staff in co-designing a scalable, inclusive and sustainable implementation model for ophthalmic remote consultation with vision self-testing (the intervention). The main study questions are: What are the barriers to uptake of the intervention and how can these be mitigated by the design of the implementation model. How do implementation outcome measures compare before and after real world application of the model.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 3, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2026

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

June 26, 2023

Last Update Submit

February 9, 2025

Conditions

Ophthalmic Disorders

Keywords

Remote consultationvisual acuity testingself-testing applicationshome-testing applications

Outcome Measures

Primary Outcomes (2)

  • Change in patient reported perceived attributes of e-health innovation score

    Change in the perceived attributes of e-health innovation score before and after experiencing remote consultation and self-testing of vision. This questionnaire results in a summated score for each patient with a minimum of 0 and a maximum of 100. Change in overall score before and after the remote consultation will be calculated for each patient and a mean change in score calculated. A higher magnitude positive change in score reflects an improved perception of the technology after the experience.

    30 months

  • Change in staff reported normalisation measure of the technology (NoMAD) score

    Change in the NoMAD score before and after implementation of the remote consultation and self-testing of vision.This questionnaire results in a summated score for each patient with a minimum of 0 and a maximum of 100. Change in overall score before and after service implementation the remote consultation will be calculated for each member of staff and a mean change in score calculated. A higher magnitude positive change in score reflects improved normalisation and acceptance of the technology after implementation.

    30 months

Study Arms (2)

Patient participants

Participants who have been assigned to remote consultation follow up following a face-to-face appointment by their clinician. Online Perceived Attributes of eHealth Technology online questionnaire before and after the remote consultation.

Other: online questionnaires

Staff participants

Medical and administrative eye clinic staff at participating centres. Normalisation process (NOMAD) online questionnaire before and after the implementation period.

Other: online questionnaires

Interventions

online questionnairesOTHER

Before and after online questionnaires

Patient participantsStaff participants

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients will reflect the diversity of the eye clinic population in terms of gender, age, social deprivation, ethnicity and sub-specialty eye condition.

You may qualify if:

  • Patients 4 years and older scheduled by their clinician for a follow up remote eye clinic consultation following an initial face-to face consultation.

You may not qualify if:

  • Patients refusing remote consultation or converted to a face-to-face appointment following scheduling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cambridge University Hospital NHS Trust

Cambridge, Cambridgeshire, CB22 4XU, United Kingdom

RECRUITING

Manchester University Hospitals NHS Trust

Manchester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Eye Diseases

Study Officials

  • Louise Allen

    Cambridge University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Allen

CONTACT

01223254665Louise.allen47@nhs.net

Mahmoud Hassan

CONTACT

01223254665mahmoud.hassan7@nhs.net

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 12, 2023

Study Start

September 3, 2023

Primary Completion

September 3, 2025

Study Completion

February 2, 2026

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

GB(2)