Would You be Happy to be Contacted About Research? (The Who)

August 23, 2022 updated by: Keele University
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.

Study Overview

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:

  1. To examine patient response rates to an invitation to complete an online Keele Health Survey questionnaire, delivered by SMS message from their general practice,
  2. 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).
  3. To estimate the number of patients that would be happy to be contacted about future research studies relevant to their health.
  4. To explore any demographic variances in completion responses.
  5. 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

Observational

Enrollment (Actual)

20969

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Staffordshire
      • Newcastle under Lyme, Staffordshire, United Kingdom, ST5 5BG
        • Keele University: School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Over 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient response rates to invitation
Time Frame: Over 4 weeks
To examine patient response rates to an invitation to complete an online questionnaire, delivered by SMS message from their general practice,
Over 4 weeks
Examine response rates using a precursor text message
Time Frame: Over 4 weeks
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).
Over 4 weeks
Explore any demographic variances in completion responses.
Time Frame: Over 4 weeks
Compare self reported data. age, gender, ethnicity,
Over 4 weeks
To estimate research question completion rate feasibility
Time Frame: Over 4 weeks
Estimationg the completion rates of the questionnaires will help to inform the future use of SMS messages and online questionnaires to collect research data.
Over 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 26, 2021

Primary Completion (ACTUAL)

March 31, 2022

Study Completion (ACTUAL)

April 30, 2022

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

March 1, 2022

First Posted (ACTUAL)

March 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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