Abstract
Background and Objectives
How trial information is communicated to participants has been described as an influential factor in deciding to take part in a trial. A trial participant information sheet (PIS), depending on its relevance, readability, or complexity, may positively or negatively impact trial recruitment. Study within a trial (SWAT) projects have been conducted to evaluate the effect of PIS design on recruitment to trials. The focus of these studies, however, has largely been on primary trial participants, those with the health condition, rather than associated others who may also be invited to take part in these trials.To address this gap, using SWAT methodology, we propose to evaluate an evidence-based enhanced PIS compared to a standard PIS on carer recruitment and retention in a multicentre “host” randomized trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers (REACH-HFpEF: ISRCTN47894539).
Methods
The SWAT will be a cluster randomized trial with allocation of the host trial sites to an enhanced host trial carer PIS (SWAT intervention) or to the standard host trial carer PIS (SWAT control). The enhanced PIS was conceptually developed by mapping key motivators and challenges (identified and prioritized in a previous SWAT; SWAT-55) that influenced informal carers' when making decisions about taking part in a trial. The sample size for the current SWAT, based on the host trial sample size and the proportion of carers expected to be recruited is 167. The primary outcomes are the proportion of carers recruited and retained: specifically the proportion who provide host trial outcomes at 4 and 12 month following entry to the trial in each SWAT group. Results will be presented as odds ratios and mean differences with 95% CIs for dichotomous and continuous outcomes, respectively.
Results
The results of this SWAT will be informative for designing future trials, especially trials involving carer populations. The SWAT will also contribute data to systematic reviews that are evaluating methods for enhancing recruitment to randomized trials.
Conclusion
The SWAT will contribute to an expansion of the trial methodology evidence base which, ultimately, may help increase trial feasibility and success and reduce research waste in the future.
How trial information is communicated to participants has been described as an influential factor in deciding to take part in a trial. A trial participant information sheet (PIS), depending on its relevance, readability, or complexity, may positively or negatively impact trial recruitment. Study within a trial (SWAT) projects have been conducted to evaluate the effect of PIS design on recruitment to trials. The focus of these studies, however, has largely been on primary trial participants, those with the health condition, rather than associated others who may also be invited to take part in these trials.To address this gap, using SWAT methodology, we propose to evaluate an evidence-based enhanced PIS compared to a standard PIS on carer recruitment and retention in a multicentre “host” randomized trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers (REACH-HFpEF: ISRCTN47894539).
Methods
The SWAT will be a cluster randomized trial with allocation of the host trial sites to an enhanced host trial carer PIS (SWAT intervention) or to the standard host trial carer PIS (SWAT control). The enhanced PIS was conceptually developed by mapping key motivators and challenges (identified and prioritized in a previous SWAT; SWAT-55) that influenced informal carers' when making decisions about taking part in a trial. The sample size for the current SWAT, based on the host trial sample size and the proportion of carers expected to be recruited is 167. The primary outcomes are the proportion of carers recruited and retained: specifically the proportion who provide host trial outcomes at 4 and 12 month following entry to the trial in each SWAT group. Results will be presented as odds ratios and mean differences with 95% CIs for dichotomous and continuous outcomes, respectively.
Results
The results of this SWAT will be informative for designing future trials, especially trials involving carer populations. The SWAT will also contribute data to systematic reviews that are evaluating methods for enhancing recruitment to randomized trials.
Conclusion
The SWAT will contribute to an expansion of the trial methodology evidence base which, ultimately, may help increase trial feasibility and success and reduce research waste in the future.
| Original language | English |
|---|---|
| Article number | 111829 |
| Journal | Journal of Clinical Epidemiology |
| Volume | 184 |
| Early online date | 4 Jun 2025 |
| DOIs | |
| Publication status | E-pub ahead of print - 4 Jun 2025 |
Keywords
- Trial recruitment
- Trial retention
- Study within a trial
- SWAT
- Participant information sheet
- Trial methodology