Condition category
Circulatory System
Date applied
08/06/2020
Date assigned
17/06/2020
Last edited
17/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Heart failure with preserved ejection fraction (HFpEF) accounts for 50% of all cases of heart failure. In the UK 920,000 people are thought to be affected by heart failure and the number of people with HFpEF is thought to be growing due to the increasing prevalence of lifestyle diseases. Researchers previously conducted an interview study with patients and healthcare providers living with or managing HFpEF to try to work out what care patients received with the view to driving improvement. This was especially important as there is low awareness of this type of heart failure and inequality in service provision (e.g. some areas don't take on referrals for HFpEF as they are not funded to do so). This study has now concluded, however, all participants provided consent to be contacted about future linked research. The researchers now plan to undertake a COVID-19-related sub-study with this panel of participants to explore the experiences of this group in these unprecedented times. Due to COVID-19, many patients and providers have experienced changes in the care they receive/provide. The researchers would like to explore the impact of these changes in order to inform an ongoing programme of research (OPTIMISE HFpEF) which aims to design an optimised management pathway for people with HFpEF.

Who can participate?
Patients, carers and healthcare professionals who participated in OPTIMISE HFpEF (https://clinicaltrials.gov/ct2/show/NCT03617848) and who provided consent to be contacted about future research

What does the study involve?
This study involves either participating in an interview with a researcher that will be digitally recorded, or completing and returning a paper-based survey. Both the interview and the survey will ask participants about their experiences of receiving/providing healthcare in the run-up to, during and after the main wave of the COVID-19 pandemic.

What are the possible benefits and risks of participating?
The researchers do not perceive any risks to participating, surveys and interviews will be fully anonymised.

Where is the study run from?
1. University of Cambridge (UK)
2. Keele University (UK)
3. University of Manchester (UK)

When is the study starting and how long is it expected to run for?
June 2020 to November 2020

Who is funding the study?
The Healthcare Improvement Studies Institute (UK)

Who is the main contact?
Prof. Christi Deaton
cd531@medschl.cam.ac.uk

Trial website

https://www.optimisehfpef.phpc.cam.ac.uk/

Contact information

Type

Public

Primary contact

Mrs Faye Forsyth

ORCID ID

http://orcid.org/0000-0003-2107-3690

Contact details

Primary Care Unit
Department of Public Health & Primary Care
Forvie Site
CB2 0QQ
United Kingdom
+44 (0)7921072847
fc349@cam.ac.uk

Type

Scientific

Additional contact

Prof Christi Deaton

ORCID ID

http://orcid.org/0000-0003-3209-0752

Contact details

Primary Care Unit
Department of Public Health & Primary Care
Forvie Site
CB2 0QQ
United Kingdom
+44 (0)1223 (3)30335
cd531@medschl.cam.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Version 4.0, dated 21/04/2020

Study information

Scientific title

Management of patients with heart failure with preserved ejection fraction: what do patients and providers need and want? A qualitative and survey-based study

Acronym

Study hypothesis

This study aims to understand what patients and providers would like/envision as optimal management of heart failure with preserved ejection fraction (HFpEF). This study is part of a larger programme of research. In April 2020 this study was amended so that the researchers could recall previous participants who provided 'consent to be contacted about future research' in order to understand perspectives since the onset of the COVID-19 pandemic.

Ethics approval

Approved 01/05/2020, North East - York Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8091, +44 (0)207 104 8079; york.rec@hra.nhs.uk), REC ref: 17/NE/0199

Study design

Observational cross-sectional qualitative and survey study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Treatment

Patient information sheet

https://www.optimisehfpef.phpc.cam.ac.uk/

Condition

Heart failure with preserved ejection fraction, impact of COVID-19 (SARS-CoV-2 infection) pandemic on healthcare received and provided

Intervention

Interviews will be performed via telephone or in person, digitally recorded and transcribed verbatim. Semi-structured interview schedules will guide questions. A survey exploring similar fields will be distributed to those who cannot commit to an interview, the survey employs Likert type scales and free text boxes to capture views, Likert responses will be quantified and free-text answers interrogated thematically. Participation is once only, there will be no follow-up.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Perspectives on care provided and received since COVID-19, assessed using interview and survey at a single timepoint (baseline)

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/06/2020

Overall trial end date

01/11/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

This is a recall study: patients, carers and healthcare professionals who participated in OPTIMISE HFpEF (https://clinicaltrials.gov/ct2/show/NCT03617848) and provided 'consent to be contacted' will be invited to participate

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

08/06/2020

Recruitment end date

01/11/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Cambridge
Institute of Public Health Cambridge Biomedical Campus Forvie Site
Cambridge
CB2 0SR
United Kingdom

Trial participating centre

Keele University
School of Primary, Community and Social Care, Faculty of Medicine and Health Sciences David Weatherall Building, Room 1.109
Keele
ST5 5BG
United Kingdom

Trial participating centre

University of Manchester
Division of Population Health, Health Services Research & Primary Care Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust

Sponsor details

S Block
Level 4
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 596472
rachel.kyd@addenbrookes.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.cuh.nhs.uk/for-researchers

Funders

Funder type

Research organisation

Funder name

The Healthcare Improvement Studies Institute

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol is available on the programme website: https://www.optimisehfpef.phpc.cam.ac.uk/. The researchers plan to submit a publication to a peer-reviewed journal and they will work with their respective communications teams to produce shorter summaries for participants.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as the researchers do not have explicit consent to share the data, even in anonymised format, outwith the research team.

Intention to publish date

30/11/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/06/2020: Trial's existence confirmed by North East - York Research Ethics Committee.