Show results to participants engaged in clinical trials

Not Applicable

Completed

• Conditions: Communicating trial results to participants; Not Applicable

• Registration Number: ISRCTN96189403
• Lead Sponsor: niversity College London

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34606495/ results (added 05/10/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37515519/ Cost and feasibility results (added 31/07/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38982441/ results of free-text questions in an embedded explanatory qualitative study (added 16/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-26
• Study Completion: 2019-09-25
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 182

Inclusion Criteria

1. Participant in the ICON8 trial
2. Currently being followed up at an ICON8 trial site in England, Scotland, Wales and Northern Ireland
2.1. Including those with reduced follow-up arrangements
3. Aged 18 years or older

Exclusion Criteria

1. Participant has previously informed their site that they do not wish to attend any further visits in relation to the ICON8 trial
2. Lost to follow-up from the ICON8 trial
3. Site staff consider the patient to be too unwell to be contacted about this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is participant’s satisfaction with the way they found out the results of ICON8, measured using a 5-point Likert scale one month after receiving the intervention.