Enhanced participant information sheet for the recruitment of caregivers to a multicentre randomised trial

Plain English Summary

Background and study aims
Recruiting people to a trial, that is people being invited and agreeing to take part in the research study, can sometimes be difficult or slower than expected. In some cases, trials are stopped early before enough people have been recruited. Ending a trial early can reduce the value of the trial results when trying to improve healthcare practices into the future. In an effort to make sure enough people are recruited to a trial so that the trial results have meaning for healthcare practice, researchers often put in place measures that they think could help with this. For example, the lead researcher may visit the study site more often to talk about the trial and recruitment, or the researchers may offer incentives (small gifts such as a voucher) to people for taking part. It is not always clear though if these measures work or not because they are not always formally studied.
When a person is being invited to take part in a trial, the researcher will give the person a participant information sheet (PIS). The PIS contains all of the information about the trial to help a person decide if they would like to take part, or not, as the case may be. The amount of detail in the PIS, the length of the PIS and how easy the PIS is to read can all affect a person's understanding of the trial, and their decision to take part. To study this we aim to compare two types of PIS which will be given to people invited to take part in a randomised trial.

Who can participate?
Carers of people with heart failure who are being invited, along with the person who has heart failure, to take part in the REACH-HFpEF trial.

What does the study involve?
The REACH-HFpEF trial is studying the effect of a home-based rehabilitation intervention for patients with heart failure. The intervention PIS for use in the REACH-HFpEF trial will be enhanced with information that carers have described as motivating as well as challenging for them when deciding to take part in a trial. The control PIS will be the usual PIS that was originally designed for use in the REACH-HFpEF trial. Twenty hospitals are taking part in the REACH-HFpEF trial, so half of these will use the enhanced PIS when inviting carers to take part, and the other half will use the usual PIS.

What are the possible benefits and risks of participating?
There are no known risks or benefits to carers by taking part in this embedded study, but it will help us find out if using an enhanced PIS, compared to using a usual PIS, is helpful when we are recruiting carers to a trial. Knowing this information will help other researchers when designing their PIS for carers in future trials.

Where is the study run from and who is funding the study?
The main REACH-HFpEF trial is funded by the UK Government through the National Institute for Health Research. This embedded PIS study has not received extra funding as it will be done as part of the main REACH-HFpEF trial.

When is the study starting and how long is it expected to run for?
September 2021 to December 2025

Who is the main contact?
Prof Valerie Smith, valerie.smith@ucd.ie

Contact information

Prof Valerie Smith
Scientific

School of Nursing, Midwifery and Health Systems
University College Dublin
Dublin
D04
Ireland

ORCID ID	0000-0003-2249-6038
Phone	+353-1-8964031
Email	valerie.smith@ucd.ie

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

NHS Greater Glasgow and Clyde
Hospital/treatment centre

Research and Innovation
Ward 11 Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
Scotland
United Kingdom

Phone	+44 (0)141 314 4012
Email	Maureen.Travers@ggc.scot.nhs.uk
Website	http://www.nhsggc.org.uk/
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

19/08/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2023 to 31/12/2025.
2. The overall end date was changed from 30/05/2025 to 31/12/2025.
12/08/2024: The contact details were updated.
29/09/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2022 to 30/06/2023.
2. The overall end date was changed from 31/08/2024 to 30/05/2025.
3. The intention to publish date was changed from 01/08/2025 to 01/05/2026.
4. The plain English summary was updated to reflect these changes.
5. The ethics approval was added.
6. The trial website was added.
01/10/2021: The CPMS number was added to the protocol/serial no. field.
24/09/2021: Internal review.
13/09/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).