Co-designing and Evaluating a Real-world Implementation Model for Remote Consultation with Vision Self-testing.
NCT ID: NCT05941182
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
200 participants
OBSERVATIONAL
2023-09-03
2026-02-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Efficacy of an Artificial Intelligence Platform to Adapt Visual Aids for Patients With Low Vision: a Randomised Controlled Trial
NCT04919837
A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight
NCT04693260
Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction
NCT05049070
Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children
NCT02061501
Investigation of Wearing Compliance of Spectacles for Myopia Control
NCT06590441
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Methods: This mixed methodology, highly pragmatic study will take place in three large NHS eye departments (in Cambridge, Peterborough and Manchester) with high levels of age, ethnic, cultural and socio-economic diversity. Qualitative and quantitative data from semi-structured interviews, ethnographic field notes in the community and the Planning and Evaluating Remote Consultation Services (PERCS) framework in hospital-based patient and staff focus groups will identify implementation challenges. An implementation model to mitigate these challenges will be co-designed with stakeholders and put into operation. Patients will be allocated to the intervention pathway at their clinician's discretion and with their implied agreement in accepting the appointment.
Implementation and service outcomes will be assessed using the Practical, Robust, Implementation and Sustainability Model of the Reach Effectiveness Adoption Implementation Maintenance (PRISM RE-AIM) framework before, during and after 14 months of operation, enabling adaptation of the model.
Online questionnaires of approximately 100 patients assigned to the intervention by their clinician, will enable quantitative analysis of change in patients' perceived attributes of the e-health innovation scores before and after its use. Online questionnaires will enable quantitative changes in the Normalisation Process (NoMAD) scores of approximately 100 staff before and after implementation of the co-deisgned model to be analysed by descriptive statistics.
The optimised implementation model for the intervention, when scaled up, could reach over 3 million patients a year and alleviate some of the pressures on United Kingdom (UK) ophthalmology services. Dissemination of the model and toolkit via websites, publications and presentations to patients, clinicians, service managers and policy makers will supportthe adoption of remote consultations using self-assessment apps, like DigiVis. This could not only improve patient care in the NHS but improve access to eyecare and vision screening for rural communities internationally.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
online questionnaires
Before and after online questionnaires
Staff participants
Medical and administrative eye clinic staff at participating centres. Normalisation process (NOMAD) online questionnaire before and after the implementation period.
online questionnaires
Before and after online questionnaires
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
online questionnaires
Before and after online questionnaires
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
4 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Manchester University NHS Foundation Trust
OTHER_GOV
University of East Anglia
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
Cambridge University Hospitals NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Louise Allen
Chief Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Louise Allen
Role: PRINCIPAL_INVESTIGATOR
Cambridge University Hospitals NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cambridge University Hospital NHS Trust
Cambridge, Cambridgeshire, United Kingdom
Manchester University Hospitals NHS Trust
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A096658
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.