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

Not Applicable

• Conditions: Trial recruitment using an enhanced participant information sheet; Not Applicable

• Registration Number: ISRCTN15757498
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-23
• Last Update Posted: 2 September 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 268

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures

Name	Time	Method
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<br>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