Patient Acceptability to Being Invited to Take Part in Research of Relevance to ThemThe WhoNCT05262114
Would You be Happy to be Contacted About Research?
An observational study of Patient Acceptability to Being Invited to Take Part in Research of Relevance to Them, run by Keele University at 1 site in United Kingdom.
Trial summary
The aim of this study is to re-examine the proportion of primary care patients that would be happy to be contacted about research of relevance to them. This study will examine the utility of SMS messages sent to patients by their general practice, with a link URL to an online questionnaire containing five research… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Acceptability to Being Invited to Take Part in Research of Relevance to Them
- How many people
- 20,969 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2021to 30 Apr 2022
- How long will I take part?
- 4 Weeks
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be comprised of individuals who are aged 18 years of age or older and must have their mobile phone number registered with their general practice. Participants will be registered with a GP surgery within the West Midlands CRN network of practices, situated within England, UK.
Who may be able to join
- Age - 18 years or over
- Mobile telephone number must be registered at general practice (doctor's surgery)
Who cannot join
- Anyone under the age of 18
- Anyone who does not have their mobile phone number registered with their general practice (doctor's surgery)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Keele University: School of Medicine
Newcastle-under-Lyme, Staffordshire, ST5 5BG
About this study
The aim of this study is to re-examine the proportion of primary care patients that would be happy to be contacted about research of relevance to them. This study will examine the utility of SMS messages sent to patients by their general practice, with a link URL to an online questionnaire containing five research questions.
Read the detailed description
Since the onset of the COVID-19 pandemic in 2019, the NIHR has played a critical role in the fight against this new disease with the delivery of COVID-19 research studies. Taking part in COVID-19 research is vital to enable effective treatments to be identified, evidenced and made available to NHS patients as quickly as possible. Over 100,000 UK participants have now enrolled in COVID-19 urgent public health research supported by the NIHR.
Keele Clinical Trials Unit (CTU) quickly implemented online data collection methodologies during 2020, in order to continue with recruitment of and retention of research participants and in response to the national lockdown and tiered systems implemented for protection of the population during the pandemic. There is now opportunity, to re-evaluate the proportion of primary care patients that would be happy to be contacted about research of relevance and also to assess the utility of online technologies, in particular SMS text messaging and an online survey platform, in the collection of the research data.
The specific research objectives of this study are:
- To examine patient response rates to an invitation to complete an online Keele Health Survey questionnaire, delivered by SMS message from their general practice,
- To examine the difference in patient response rates to the invitation to participate in the research study with and without a precursor test message (SMS).
- To estimate the number of patients that would be happy to be contacted about future research studies relevant to their health.
- To explore any demographic variances in completion responses.
- To estimate research question completion rate feasibility, for future use of SMS messages containing a link URL to an online Keele Health Survey questionnaire to collect research data.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-cursor text | A pre-notification text message (SMS) will be sent to eligible people informing them of their imminent invitation to participate in The Who, two days later a brief text message (SMS) will be sent from the general practice to eligible people, inviting them to participate in The Who. | |
| Invitation only | A brief text message (SMS) will be sent from the general practice to eligible people, inviting them to participate in The Who. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the proportion of people happy to be contacted by their practice
To estimate the proportion of people who are happy for their practice to contact them about any future research studies, which are relevant to their health.
Measured: Over 4 weeks
Secondary outcomes (4)
Patient response rates to invitation
To examine patient response rates to an invitation to complete an online questionnaire, delivered by SMS message from their general practice,
Measured: Over 4 weeks
Examine response rates using a precursor text message
To examine the difference in patient response rates to the invitation to participate in the research study with and without a precursor test message (SMS).
Measured: Over 4 weeks
Explore any demographic variances in completion responses.
Compare self reported data. age, gender, ethnicity,
Measured: Over 4 weeks
To estimate research question completion rate feasibility
Estimationg the completion rates of the questionnaires will help to inform the future use of SMS messages and online questionnaires to collect research data.
Measured: Over 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start26 Nov 2021
- Primary completion31 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Acceptability to Being Invited to Take Part in Research of Relevance to ThemStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 20,969 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Lawton, MPhil, Principal investigator, Head of Operations - Clinical Trials UnitChristian Mallen, Professor, Study director, Head of School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262114
- Sponsor's protocol ID
- RG-0322-21
- Other IDs
- IRAS Number: 291348
- Acronym
- The Who
- Status last verified
- Aug 2022
- First submitted
- 25 Nov 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Would You be Happy to be Contacted About Research?
- ClinicalTrials.gov ID
- NCT05262114
- Acronym / sponsor ID
- The Who / RG-0322-21
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,969 participants (actual)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 2 Mar 2022 (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.
The aim of this study is to re-examine the proportion of primary care patients that would be happy to be contacted about research of relevance to them. This study will examine the utility of SMS messages sent to patients by their general practice, with a link URL to an online questionnaire containing five research questions.
Detailed description
Since the onset of the COVID-19 pandemic in 2019, the NIHR has played a critical role in the fight against this new disease with the delivery of COVID-19 research studies. Taking part in COVID-19 research is vital to enable effective treatments to be identified, evidenced and made available to NHS patients as quickly as possible. Over 100,000 UK participants have now enrolled in COVID-19 urgent public health research supported by the NIHR.
Keele Clinical Trials Unit (CTU) quickly implemented online data collection methodologies during 2020, in order to continue with recruitment of and retention of research participants and in response to the national lockdown and tiered systems implemented for protection of the population during the pandemic. There is now opportunity, to re-evaluate the proportion of primary care patients that would be happy to be contacted about research of relevance and also to assess the utility of online technologies, in particular SMS text messaging and an online survey platform, in the collection of the research data.
The specific research objectives of this study are:
- To examine patient response rates to an invitation to complete an online Keele Health Survey questionnaire, delivered by SMS message from their general practice,
- To examine the difference in patient response rates to the invitation to participate in the research study with and without a precursor test message (SMS).
- To estimate the number of patients that would be happy to be contacted about future research studies relevant to their health.
- To explore any demographic variances in completion responses.
- To estimate research question completion rate feasibility, for future use of SMS messages containing a link URL to an online Keele Health Survey questionnaire to collect research data.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-cursor text | – | –A pre-notification text message (SMS) will be sent to eligible people informing them of their imminent invitation to participate in The Who, two days later a brief text message (SMS) will be sent from the general practice to eligible people, inviting them to participate in The Who. |
| Invitation only | – | –A brief text message (SMS) will be sent from the general practice to eligible people, inviting them to participate in The Who. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of individuals who are aged 18 years of age or older and must have their mobile phone number registered with their general practice. Participants will be registered with a GP surgery within the West Midlands CRN network of practices, situated within England, UK.
Key inclusion criteria (2 listed)
- Age - 18 years or over
- Mobile telephone number must be registered at general practice (doctor's surgery)
Key exclusion criteria (2 listed)
- Anyone under the age of 18
- Anyone who does not have their mobile phone number registered with their general practice (doctor's surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate the proportion of people happy to be contacted by their practice
Time frame: Over 4 weeks
To estimate the proportion of people who are happy for their practice to contact them about any future research studies, which are relevant to their health.
4 secondary outcomes
Patient response rates to invitation
Time frame: Over 4 weeks
Examine response rates using a precursor text message
Time frame: Over 4 weeks
Explore any demographic variances in completion responses.
Time frame: Over 4 weeks
To estimate research question completion rate feasibility
Time frame: Over 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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.
Sarah Lawton, MPhil principal investigator
Head of Operations - Clinical Trials Unit
Christian Mallen, Professor study director
Head of School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Acceptability to Being Invited to Take Part in Research of Relevance to Them, run by Keele University at 1 site in United Kingdom.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the proportion of people happy to be contacted by their practice (time frame: Over 4 weeks). 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 24 Aug 2022.