Management of patients with heart failure with preserved ejection fraction: what do patients and providers need and want?

ISRCTN	ISRCTN13471603
DOI	https://doi.org/10.1186/ISRCTN13471603
Secondary identifying numbers	Version 4.0, dated 21/04/2020

Submission date: 08/06/2020
Registration date: 17/06/2020
Last edited: 05/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Study website

Contact information

Mrs Faye Forsyth
Public

Primary Care Unit
Department of Public Health & Primary Care
Forvie Site
CB2 0QQ
United Kingdom

ORCID ID	0000-0003-2107-3690
Phone	+44 (0)7921072847
Email	fc349@cam.ac.uk

Prof Christi Deaton
Scientific

Primary Care Unit
Department of Public Health & Primary Care
Forvie Site
CB2 0QQ
United Kingdom

ORCID ID	0000-0003-3209-0752
Phone	+44 (0)1223 (3)30335
Email	cd531@medschl.cam.ac.uk

Study information

Study design	Observational cross-sectional qualitative and survey study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Other
Study type	Treatment
Participant information sheet	https://www.optimisehfpef.phpc.cam.ac.uk/
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
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(s)	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
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
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 study start date	01/06/2020
Overall study end date	01/11/2020

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	50
Total final enrolment	50
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 exclusion criteria	Does not meet inclusion criteria
Recruitment start date	08/06/2020
Recruitment end date	01/11/2020

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

University of Cambridge

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

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

University of Manchester

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

Sponsor information

Cambridge University Hospitals NHS Foundation Trust
Hospital/treatment centre

S Block
Level 4
Addenbrooke's Hospital
Cambridge
CB2 0QQ
England
United Kingdom

Phone	+44 (0)1223 596472
Email	rachel.kyd@addenbrookes.nhs.uk
Website	https://www.cuh.nhs.uk/for-researchers
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Research organisation

The Healthcare Improvement Studies Institute

No information available

Results and Publications

Intention to publish date	30/11/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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 plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		26/11/2020	18/05/2021	Yes	No
Results article		05/01/2021	18/05/2021	Yes	No
Protocol article		26/11/2019	05/10/2022	Yes	No
Protocol file	version 2	26/07/2018	05/10/2022	No	No
HRA research summary			26/07/2023	No	No

Additional files

ISRCTN13471603_PROTOCOL_Qualitative_V2_26Jul18.pdf

Editorial Notes

05/10/2022: Publication reference added and protocol (not peer reviewed) uploaded.
18/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
17/06/2020: Trial's existence confirmed by North East - York Research Ethics Committee.