RecruitmentWhAMNCT06049056
Which Automated Methodology?
An observational study of Recruitment, run by Keele University at 1 site in United Kingdom.
Trial summary
The aim of this study is to identify the modes of clinical research invitation that optimise digital responses from participants in primary care settings. This will be achieved by investigating and characterising response rates (recruitment) obtained from a hybrid of digital recruitment methods, in general practice… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recruitment
- What is being tested?
- Invitation
- How many people
- 8,880 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2023to 31 Jan 2024
- 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: All adults of age 18 years and over, registered at a participating general practice, will be eligible to participate.
Who may be able to join
- Adults 18 years of age or over.
- Adults registered at participating general practices.
Who cannot join
- People under the age of 18 years.
- Adults who have asked for their medical records not to be used for research and have a relevant code indicating this included on their records.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to identify the modes of clinical research invitation that optimise digital responses from participants in primary care settings. This will be achieved by investigating and characterising response rates (recruitment) obtained from a hybrid of digital recruitment methods, in general practice settings.
Responses to this research will provide a single data item on general health to further characterise the sample and whether, since Covid-19, adults are more or less willing to participate in research.
Read the detailed description
When conducting research, which data collection method to use, can be a difficult decision for many researchers. Choosing an inappropriate method can result in untrustworthy findings and therefore wrong conclusions. The use of digital technologies to improve the quality and reduce the cost of health care services, is a vision set out by government in 2021. How digital technologies can be used, in carrying out health research, is an area that there is not a lot known about and needs further research. This study will therefore investigate how to invite people to take part in research and which digital methods people use, to take part.
It is commonly known that the recruitment of research participants from primary care settings is difficult. The Covid-19 pandemic however highlighted the importance of primary care, in the delivery of healthcare research, which is the setting where most patients visit. Being contacted about a research study of importance, is the first step in a patients journey towards taking part in a research study. Patients will though, often drop out before they actually consent to take part in a research study. A recent NIHR survey suggested a positive increase in the public's attitude to health research. This research study will also investigate whether, since Covid-19, people are actually more or less willing to take part in research and their reasons for this.
The digital methods used for collecting data in this study, will include: automated check-in screens; Short Messaging Service (SMS or text message) with online data collection; and postal invitations from the general practice, with online data collection accessed by a quick response (QR) code or website. All people of age 18 years and over, registered at a participating general practice, will be allowed to take part. Data collected will include demographics, a data item on general health and one on willingness to take part in research.
- Conditions
- Recruitment
- Being tested
- Invitation
- Keywords
- Primary care, Digital data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvitationOther
During Recruitment Method 3, x4 practices will send letters with a URL link providing the potential participant with access to the online questionnaire, x4 practices will send letters with a QR code providing the potential participant with access to the online questionnaire, and x2 practices will send letters with a URL link and a QR code providing the potential participant with access to the online questionnaire,
| Study group | Role | What they receive |
|---|---|---|
| General Practice 1 | General Practice 1 use the following methods to invite participation to the study:
Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link to an online questionnaire Receives: Other: Invitation | |
| General Practice 2 | General Practice 2 use the following methods to invite participation to the study:
Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link to an online questionnaire Receives: Other: Invitation | |
| General Practice 3 | General Practice 3 use the following methods to invite participation to the study:
Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link to an online questionnaire Receives: Other: Invitation | |
| General Practice 4 | General Practice 4 use the following methods to invite participation to the study:
Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link to an online questionnaire Receives: Other: Invitation | |
| General Practice 5 | General Practice 5 use the following methods to invite participation to the study:
Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a QR code providing access to an online questionnaire Receives: Other: Invitation | |
| General Practice 6 | General Practice 6 use the following methods to invite participation to the study:
Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a QR code providing access to an online questionnaire Receives: Other: Invitation | |
| General Practice 7 | General Practice 7 use the following methods to invite participation to the study:
Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a QR code providing access to an online questionnaire Receives: Other: Invitation | |
| General Practice 8 | General Practice 8 use the following methods to invite participation to the study:
Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a QR code providing access to an online questionnaire Receives: Other: Invitation | |
| General Practice 9 | General Practice 9 use the following methods to invite participation to the study:
Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link and a QR code providing access to an online questionnaire Receives: Other: Invitation | |
| General Practice 10 | General Practice 10 use the following methods to invite participation to the study:
Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link and a QR code providing access to an online questionnaire Receives: Other: Invitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment (RM1)
Number of participants recruited to the WhAM study following receipt of an invitation to participate from an automated check-in-screen.
Measured: 14 days
Recruitment (RM2)
Number of participants recruited to the WhAM study following receipt of an invitation to participate from an SMS sent from the general practice.
Measured: 14 Days
Recruitment (RM3a)
Number of participants recruited to the WhAM study following receipt of an invitation to participate from an invitation letter sent from the general practice containing a QR code.
Measured: 14 days
Recruitment (RM3b)
Number of participants recruited to the WhAM study following receipt of an invitation to participate from an invitation letter sent from the general practice containing a URL link.
Measured: 14 days
Secondary outcomes (2)
Willingness to participate in research since the COVID-19 pandemic
Number of adults that are less willing to participate in research since the Covid-19 pandemic.
Measured: 14 days
Willingness to participate in research since the COVID-19 pandemic
Number of adults that are more willing to participate in research since the Covid-19 pandemic.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start9 Oct 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecruitmentStudies 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
- 8,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Lawton, Principal investigator, Keele CTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049056
- Sponsor's protocol ID
- RG-0369-23
- Acronym
- WhAM
- Status last verified
- Mar 2024
- First submitted
- 15 Sep 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable data will be collected
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Automated Methodology?
- ClinicalTrials.gov ID
- NCT06049056
- Acronym / sponsor ID
- WhAM / RG-0369-23
- Conditions
- Recruitment
- Keywords
- Primary care, Digital data collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,880 participants (actual)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 21 Sep 2023 (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 identify the modes of clinical research invitation that optimise digital responses from participants in primary care settings. This will be achieved by investigating and characterising response rates (recruitment) obtained from a hybrid of digital recruitment methods, in general practice settings.
Responses to this research will provide a single data item on general health to further characterise the sample and whether, since Covid-19, adults are more or less willing to participate in research.
Detailed description
When conducting research, which data collection method to use, can be a difficult decision for many researchers. Choosing an inappropriate method can result in untrustworthy findings and therefore wrong conclusions. The use of digital technologies to improve the quality and reduce the cost of health care services, is a vision set out by government in 2021. How digital technologies can be used, in carrying out health research, is an area that there is not a lot known about and needs further research. This study will therefore investigate how to invite people to take part in research and which digital methods people use, to take part.
It is commonly known that the recruitment of research participants from primary care settings is difficult. The Covid-19 pandemic however highlighted the importance of primary care, in the delivery of healthcare research, which is the setting where most patients visit. Being contacted about a research study of importance, is the first step in a patients journey towards taking part in a research study. Patients will though, often drop out before they actually consent to take part in a research study. A recent NIHR survey suggested a positive increase in the public's attitude to health research. This research study will also investigate whether, since Covid-19, people are actually more or less willing to take part in research and their reasons for this.
The digital methods used for collecting data in this study, will include: automated check-in screens; Short Messaging Service (SMS or text message) with online data collection; and postal invitations from the general practice, with online data collection accessed by a quick response (QR) code or website. All people of age 18 years and over, registered at a participating general practice, will be allowed to take part. Data collected will include demographics, a data item on general health and one on willingness to take part in research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| General Practice 1 | – | Other: InvitationGeneral Practice 1 use the following methods to invite participation to the study: Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link to an online questionnaire |
| General Practice 2 | – | Other: InvitationGeneral Practice 2 use the following methods to invite participation to the study: Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link to an online questionnaire |
| General Practice 3 | – | Other: InvitationGeneral Practice 3 use the following methods to invite participation to the study: Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link to an online questionnaire |
| General Practice 4 | – | Other: InvitationGeneral Practice 4 use the following methods to invite participation to the study: Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link to an online questionnaire |
| General Practice 5 | – | Other: InvitationGeneral Practice 5 use the following methods to invite participation to the study: Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a QR code providing access to an online questionnaire |
| General Practice 6 | – | Other: InvitationGeneral Practice 6 use the following methods to invite participation to the study: Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a QR code providing access to an online questionnaire |
| General Practice 7 | – | Other: InvitationGeneral Practice 7 use the following methods to invite participation to the study: Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a QR code providing access to an online questionnaire |
| General Practice 8 | – | Other: InvitationGeneral Practice 8 use the following methods to invite participation to the study: Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a QR code providing access to an online questionnaire |
| General Practice 9 | – | Other: InvitationGeneral Practice 9 use the following methods to invite participation to the study: Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link and a QR code providing access to an online questionnaire |
| General Practice 10 | – | Other: InvitationGeneral Practice 10 use the following methods to invite participation to the study: Recruitment Method 1 (RM1): Automated check-in screens containing research questions Recruitment Method 2 (RM2): SMS invites with URL link to an online questionnaire Recruitment Method 3 (RM3): Mailing containing a URL link and a QR code providing access to an online questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults of age 18 years and over, registered at a participating general practice, will be eligible to participate.
Key inclusion criteria (2 listed)
- Adults 18 years of age or over.
- Adults registered at participating general practices.
Key exclusion criteria (2 listed)
- People under the age of 18 years.
- Adults who have asked for their medical records not to be used for research and have a relevant code indicating this included on their records.
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 |
|---|---|---|
| InvitationDuring Recruitment Method 3, x4 practices will send letters with a URL link providing the potential participant with access to the online questionnaire, x4 practices will send letters with a QR code providing the potential participant with access to the online questionnaire, and x2 practices will send letters with a URL link and a QR code providing the potential participant with access to the online questionnaire, | Other | General Practice 1, General Practice 10, General Practice 2, General Practice 3, General Practice 4, General Practice 5, General Practice 6, General Practice 7, General Practice 8, General Practice 9 |
Primary outcome
Recruitment (RM1)
Time frame: 14 days
Number of participants recruited to the WhAM study following receipt of an invitation to participate from an automated check-in-screen.
Recruitment (RM2)
Time frame: 14 Days
Number of participants recruited to the WhAM study following receipt of an invitation to participate from an SMS sent from the general practice.
Recruitment (RM3a)
Time frame: 14 days
Number of participants recruited to the WhAM study following receipt of an invitation to participate from an invitation letter sent from the general practice containing a QR code.
Recruitment (RM3b)
Time frame: 14 days
Number of participants recruited to the WhAM study following receipt of an invitation to participate from an invitation letter sent from the general practice containing a URL link.
2 secondary outcomes
Willingness to participate in research since the COVID-19 pandemic
Time frame: 14 days
Willingness to participate in research since the COVID-19 pandemic
Time frame: 14 days
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 20 Mar 2024.
- Individual participant dataSharing planned: No. No identifiable data will be collected
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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 principal investigator
Keele CTU
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 Recruitment, 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 20 Mar 2024. 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?
Recruitment (RM1) (time frame: 14 days). The study lists 4 primary outcomes in all. 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 20 Mar 2024.