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

Evidence-based enhanced participant information sheet for recruiting caregivers to the REACH-HFpEF multicentre randomised trial: A Study Within a Trial (SWAT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15757498

Enrollment

268

Registered

2021-09-23

Start date

2021-11-01

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Trial recruitment using an enhanced participant information sheet Other

Interventions

Part of the REACH-HFpEF multi-center trial (ISRCTN47894539) to assess the effect of using the enhanced compared to the standard participant information. REACH-HFpEF trial sites will be randomised on

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: Carers/support persons, who are aged 18 years and older and who are being invited to take part in the REACH-HFpEF host trial with their care recipient.

Exclusion criteria

Exclusion criteria: Carers/support persons who decline to take part in the REACH-HFpEF host trial.

Design outcomes

Primary

Measure	Time frame
1. Proportion of caregivers who are approached and agree to participate in the REACH-HFpEF trial measured using the numbers of caregivers who have consented and are enrolled in the trial 2. Proportion of caregivers allocated in each intervention and control group who provide REACH-HFpEF trial outcomes measured using the numbers of participants who return outcome questionnaires at 4- and 12-months follow-up	—

Measure

Time frame

1. Proportion of caregivers who are approached and agree to participate in the REACH-HFpEF trial measured using the numbers of caregivers who have consented and are enrolled in the trial 2. Proportion of caregivers allocated in each intervention and control group who provide REACH-HFpEF trial outcomes measured using the numbers of participants who return outcome questionnaires at 4- and 12-months follow-up

—

Secondary

Measure	Time frame
1. Caregiver’s level of satisfaction with the PIS (measured on a Likert scale of 1 not at all satisfied to 5 extremely satisfied) in both the intervention PIS and control PIS groups measured at baseline following randomisation to the trial, and at 4-months follow-up 2. Caregivers’ priority motivators and barriers for participating in the REACH-HFpEF trial measured a validated questionnaire (Likert scale options from 1 very unimportant to 5 very important) at entry to the trial and at 4 months after enrolling in the trial	—

Measure

Time frame

1. Caregiver’s level of satisfaction with the PIS (measured on a Likert scale of 1 not at all satisfied to 5 extremely satisfied) in both the intervention PIS and control PIS groups measured at baseline following randomisation to the trial, and at 4-months follow-up 2. Caregivers’ priority motivators and barriers for participating in the REACH-HFpEF trial measured a validated questionnaire (Likert scale options from 1 very unimportant to 5 very important) at entry to the trial and at 4 months after enrolling in the trial

—

Countries

England, Scotland, United Kingdom

Outcome results

None listed

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