NCT06049056

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,880

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

September 15, 2023

Last Update Submit

March 19, 2024

Conditions

Keywords

Primary careDigital data collection

Outcome Measures

Primary Outcomes (4)

  • Recruitment (RM1)

    Number of participants recruited to the WhAM study following receipt of an invitation to participate from an automated check-in-screen.

    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.

    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.

    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.

    14 days

Secondary Outcomes (2)

  • Willingness to participate in research since the COVID-19 pandemic

    14 days

  • Willingness to participate in research since the COVID-19 pandemic

    14 days

Study Arms (10)

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

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

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

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

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

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

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

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

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

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

Other: Invitation

Interventions

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 1General Practice 10General Practice 2General Practice 3General Practice 4General Practice 5General Practice 6General Practice 7General Practice 8General Practice 9

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults of age 18 years and over, registered at a participating general practice, will be eligible to participate.

You may qualify if:

  • Adults 18 years of age or over.
  • Adults registered at participating general practices.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIHR CRN: West Midlands

Wolverhampton, WV7 3FA, United Kingdom

Location

Study Officials

  • Sarah Lawton

    Keele CTU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 21, 2023

Study Start

October 9, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

No identifiable data will be collected

Locations