- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05262114
Would You be Happy to be Contacted About Research? (The Who)
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Staffordshire
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Newcastle under Lyme, Staffordshire, United Kingdom, ST5 5BG
- Keele University: School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age - 18 years or over
- Mobile telephone number must be registered at general practice (doctor's surgery)
Exclusion Criteria:
- Anyone under the age of 18
- Anyone who does not have their mobile phone number registered with their general practice (doctor's surgery)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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Invitation only
A brief text message (SMS) will be sent from the general practice to eligible people, inviting them to participate in The Who.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Estimate the proportion of people happy to be contacted by their practice
Time Frame: Over 4 weeks
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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.
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Over 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient response rates to invitation
Time Frame: Over 4 weeks
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To examine patient response rates to an invitation to complete an online questionnaire, delivered by SMS message from their general practice,
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Over 4 weeks
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Examine response rates using a precursor text message
Time Frame: Over 4 weeks
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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).
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Over 4 weeks
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Explore any demographic variances in completion responses.
Time Frame: Over 4 weeks
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Compare self reported data.
age, gender, ethnicity,
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Over 4 weeks
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To estimate research question completion rate feasibility
Time Frame: Over 4 weeks
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Estimationg the completion rates of the questionnaires will help to inform the future use of SMS messages and online questionnaires to collect research data.
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Over 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah Lawton, MPhil, Head of Operations - Clinical Trials Unit
- Study Director: Christian Mallen, Professor, Head of School of Medicine
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
Other Study ID Numbers
- RG-0322-21
- IRAS Number: 291348 (OTHER: Integrated Research Application System (IRAS))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.