- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06049056
Which Automated Methodology? (WhAM)
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Sarah Lawton, MPhil
- Phone Number: 34887 +441782734887
- Email: s.a.lawton@keele.ac.uk
Study Locations
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Wolverhampton, United Kingdom, WV7 3FA
- NIHR CRN: West Midlands
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults 18 years of age or over.
- Adults registered at participating general practices.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 |
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,
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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 |
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,
|
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 |
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,
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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 |
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,
|
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 |
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,
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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 |
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,
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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 |
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,
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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 |
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,
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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 |
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,
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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 |
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,
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment (RM1)
Time Frame: 14 days
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Number of participants recruited to the WhAM study following receipt of an invitation to participate from an automated check-in-screen.
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14 days
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Recruitment (RM2)
Time Frame: 14 Days
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Number of participants recruited to the WhAM study following receipt of an invitation to participate from an SMS sent from the general practice.
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14 Days
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Recruitment (RM3a)
Time Frame: 14 days
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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.
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14 days
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Recruitment (RM3b)
Time Frame: 14 days
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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.
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14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Willingness to participate in research since the COVID-19 pandemic
Time Frame: 14 days
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Number of adults that are less willing to participate in research since the Covid-19 pandemic.
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14 days
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Willingness to participate in research since the COVID-19 pandemic
Time Frame: 14 days
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Number of adults that are more willing to participate in research since the Covid-19 pandemic.
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14 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah Lawton, Keele CTU
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RG-0369-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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