Cataract AfterNCT04885868
Patient Acceptability of Autonomous Telemedicine
An observational study of Cataract After, run by Ufonia.
Trial summary
Patients will have an automated call supervised by a human clinician to check how they are after uncomplicated cataract surgery as part of their standard of care. The study aims to evaluate the acceptability of this system through a net promoter score and for a subsection of patients using a qualitative interview. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract After
- What is being tested?
- This study assess acceptability of autonomous conversation as part of cataract surgery follow up.
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 24 May 2021to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing uncomplicated cataract surgery who are suitable for telephone follow up
Who may be able to join
- Routine, first or second eye cataract surgery with intraocular lens implantation without complications.
- Above the age of 16.
- Capacity to give consent
- Access to a phone number.
- Satisfactory command of English for a phone-based consultation.
Who cannot join
- Combined glaucoma surgery
- Retinal or glaucoma laser treatment
- Corneal dystrophy or grafts
- Combined vitreoretinal surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Patient Acceptability of the Use of an Autonomous Telephone System for the Delivery of Clinical Follow-up Conversations After Cataract Surgery
Patients will have an automated call supervised by a human clinician to check how they are after uncomplicated cataract surgery as part of their standard of care. The study aims to evaluate the acceptability of this system through a net promoter score and for a subsection of patients using a qualitative interview.
Read the detailed description
The study will be a qualitative cohort design. The target will be to recruit 1000 patients who meet the inclusion criteria and provide consent following the process set out below. This represents recruiting 75% of the total projected number of patients who will undergo cataract surgery during the trial period.
Currently at Buckinghamshire Healthcare NHS Trust patients who have uncomplicated cataract surgery are given post-op instructions and assessed for their suitability to undergo telephone follow-up by the nursing team in the discharge lounge. If deemed suitable for a telephone call (equivalent to the criteria for inclusion in this study, including the capacity to consent) a date to expect a telephone follow-up call is given. During the study these patients will also be given an information leaflet and information relating to the study by the nursing team.
The post-op telephone call occurs three weeks later and at the start of this call patients will be asked if they consent to take part as well as if they have any further questions. If they agree to participate in the study their follow-up will be conducted by the autonomous human supervised system as well as additional questions to determine the acceptability of the system. If they decline to participate or are unable to consent (for example, the unlikely event that their capacity has become impaired following surgery), they will have their follow-up conducted by a human clinician as per the current standard of care.
For those patients who provide consent the autonomous human supervised system comprises several conversational elements which occur in order:
- Greeting and introduction
- Identification of patient
- Cataract follow-up symptom questions
- Patient's queries and frequently asked questions
- Acceptability questions
- Closure of call
If all of the questions aren't asked by the autonomous system or the human supervisor feels additional information is required they can ask these at the end of the call. The patient may withdraw from the automated call at any point.
Up to 50 patients (5% of total recruited) who consent to participate will be invited to take part in a subsequent structured telephone interview with a researcher to explore in greater depth their experience of using the system. The interview will last no more that 30 minutes and will be conducted within one week of the follow-up call.
Anonymised data from the patient ratings will undergo standard statistical analysis. The qualitative responses to the reasons why they gave their score as well as the answers to the in-depth interviews will undergo thematic analysis to understand patients' perceptions of having the follow-up conducted by the autonomous human supervised system.
- Conditions
- Cataract After
- Being tested
- This study assess acceptability of autonomous conversation as part of cataract surgery follow up.
- Medical subject headings
- Capsule Opacification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study assess acceptability of autonomous conversation as part of cataract surgery follow up.Other
This study assess acceptability of autonomous conversation as part of cataract surgery follow up.
What is being measured
The primary outcome is the main question the study is designed to answer.
A score out of 10 rating the autonomous system
The patient will score the autonomous system out of 10 and a subsection of patients will have qualitative interviews.
Measured: It is anticipated the study will occur over 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start24 May 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract AfterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufonia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Buckinghamshire Healthcare NHS Trust, Innovate UK
- Responsible party
- Sponsor
- Investigators
- Guy Mole, BSc MBBS MSc, Principal investigator, Ufonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885868
- Sponsor's protocol ID
- RXQ
- Status last verified
- May 2021
- First submitted
- 29 Apr 2021
- Last updated
- 13 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researcher undertaking the qualitative interviews will get access to the patient identifier for those who have consented to take part in the interview so that they can access their contact details from the hospital record.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Acceptability of the Use of an Autonomous Telephone System for the Delivery of Clinical Follow-up Conversations After Cataract Surgery
- ClinicalTrials.gov ID
- NCT04885868
- Acronym / sponsor ID
- RXQ
- Conditions
- Cataract After
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- UfoniaIndustry (pharma, biotech, devices)
- Collaborators
- Buckinghamshire Healthcare NHS Trust, Innovate UK
- Study start
- 24 May 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will have an automated call supervised by a human clinician to check how they are after uncomplicated cataract surgery as part of their standard of care. The study aims to evaluate the acceptability of this system through a net promoter score and for a subsection of patients using a qualitative interview.
Detailed description
The study will be a qualitative cohort design. The target will be to recruit 1000 patients who meet the inclusion criteria and provide consent following the process set out below. This represents recruiting 75% of the total projected number of patients who will undergo cataract surgery during the trial period.
Currently at Buckinghamshire Healthcare NHS Trust patients who have uncomplicated cataract surgery are given post-op instructions and assessed for their suitability to undergo telephone follow-up by the nursing team in the discharge lounge. If deemed suitable for a telephone call (equivalent to the criteria for inclusion in this study, including the capacity to consent) a date to expect a telephone follow-up call is given. During the study these patients will also be given an information leaflet and information relating to the study by the nursing team.
The post-op telephone call occurs three weeks later and at the start of this call patients will be asked if they consent to take part as well as if they have any further questions. If they agree to participate in the study their follow-up will be conducted by the autonomous human supervised system as well as additional questions to determine the acceptability of the system. If they decline to participate or are unable to consent (for example, the unlikely event that their capacity has become impaired following surgery), they will have their follow-up conducted by a human clinician as per the current standard of care.
For those patients who provide consent the autonomous human supervised system comprises several conversational elements which occur in order:
- Greeting and introduction
- Identification of patient
- Cataract follow-up symptom questions
- Patient's queries and frequently asked questions
- Acceptability questions
- Closure of call
If all of the questions aren't asked by the autonomous system or the human supervisor feels additional information is required they can ask these at the end of the call. The patient may withdraw from the automated call at any point.
Up to 50 patients (5% of total recruited) who consent to participate will be invited to take part in a subsequent structured telephone interview with a researcher to explore in greater depth their experience of using the system. The interview will last no more that 30 minutes and will be conducted within one week of the follow-up call.
Anonymised data from the patient ratings will undergo standard statistical analysis. The qualitative responses to the reasons why they gave their score as well as the answers to the in-depth interviews will undergo thematic analysis to understand patients' perceptions of having the follow-up conducted by the autonomous human supervised system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing uncomplicated cataract surgery who are suitable for telephone follow up
Key inclusion criteria (5 listed)
- Routine, first or second eye cataract surgery with intraocular lens implantation without complications.
- Above the age of 16.
- Capacity to give consent
- Access to a phone number.
- Satisfactory command of English for a phone-based consultation.
Key exclusion criteria (4 listed)
- Combined glaucoma surgery
- Retinal or glaucoma laser treatment
- Corneal dystrophy or grafts
- Combined vitreoretinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study assess acceptability of autonomous conversation as part of cataract surgery follow up.This study assess acceptability of autonomous conversation as part of cataract surgery follow up. | Other | – |
Primary outcome
A score out of 10 rating the autonomous system
Time frame: It is anticipated the study will occur over 3 months
The patient will score the autonomous system out of 10 and a subsection of patients will have qualitative interviews.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: Yes. The researcher undertaking the qualitative interviews will get access to the patient identifier for those who have consented to take part in the interview so that they can access their contact details from the hospital record.
Related trials for Cataract After
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
Cataract
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Mole, BSc MBBS MSc principal investigator
Ufonia
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract After, run by Ufonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Mole, BSc MBBS MSc (07760270520, gm@ufonia.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A score out of 10 rating the autonomous system (time frame: It is anticipated the study will occur over 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.