Impact on recruitment of using an infographic in addition to the participant information sheet.

A cluster randomised study within a trial (SWAT) embedded within the EASY Study to assess the impact on recruitment of using an infographic in addition to the standard participate information sheet to explain the two treatment arms of the EASY Study to parents/guardians of eligible participants.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11990876

Enrollment

584

Registered

2024-06-19

Start date

2024-05-07

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impact on recruitment of using an infographic in addition to the participant information sheet in a paediatric emergency setting Pregnancy and Childbirth

Interventions

Intervention 1: EASY study (https://www.isrctn.com/ISRCTN10907780) sites allocated to the SWAT intervention arm will provide parents/guardians with an infographic in addition to the standard participa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Must be a parent or guardian of a participant eligible for the EASY Study (https://www.isrctn.com/ISRCTN10907780).

Exclusion criteria

Exclusion criteria: Not meeting the participant inclusion criteria

Design outcomes

Primary

Measure	Time frame
Recruitment rate (%) measured using data collected in study records by counting the number of participants who are recruited at the end of the recruitment period expressed as the percentage of the total sample size	—

Secondary

Measure	Time frame
1. Withdrawal rate (%) measured using data collected in study records by counting the number of participants who are withdrawn immediately post-randomisation to the EASY Study expressed as the percentage of the total sample size 2. Retention rate (%) measured using data collected in study records by counting the number of participants who are retained at 28 days post-randomisation to the EASY Study expressed as the percentage of the total sample size 3. Cost per participant recruited and participant retained measured using data collected in study records and calculated by dividing the total costs associated with the infographic by the number of participants recruited (primary outcome) and the number of participants retained (secondary outcome) at 28 days post-randomisation to the EASY Study 4. Parent/Guardian satisfaction with and understanding of the consent process measured using a bespoke questionnaire within 48 hours post-screening for the EASY Study 5. Quality of parent/guardian decision-making measured using a bespoke questionnaire on consent within 48 hours post-screening for the EASY Study	—

Measure

Time frame

1. Withdrawal rate (%) measured using data collected in study records by counting the number of participants who are withdrawn immediately post-randomisation to the EASY Study expressed as the percentage of the total sample size 2. Retention rate (%) measured using data collected in study records by counting the number of participants who are retained at 28 days post-randomisation to the EASY Study expressed as the percentage of the total sample size 3. Cost per participant recruited and participant retained measured using data collected in study records and calculated by dividing the total costs associated with the infographic by the number of participants recruited (primary outcome) and the number of participants retained (secondary outcome) at 28 days post-randomisation to the EASY Study 4. Parent/Guardian satisfaction with and understanding of the consent process measured using a bespoke questionnaire within 48 hours post-screening for the EASY Study 5. Quality of parent/guardian decision-making measured using a bespoke questionnaire on consent within 48 hours post-screening for the EASY Study

—

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactAshley Agus

ashley.agus@nictu.hscni.net+44 (0)28 961 51447

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026