NCT05313880

Brief Summary

Heart failure is a chronic health condition associated with significant symptoms, an increased need of support from the NHS, and typically is associated with a reduction in life expectancy. The covid pandemic has made it more difficult for the NHS to deliver high quality care to the 1 million patients living with heart failure in the UK. NHS England plans that digitalisation of services will help, increasing efficiency and improving ability of patients to self-care and manage their conditions. "Digitalisation" includes the use of digital tools for health, such as Apps and online resources \& support. But the typical heart failure patient does not receive a diagnosis of heart failure until their 70s or 80s, creating a significant risk of digital exclusion. The heart failure failure community doesn't have any information about which tools (if any) heart failure patients are using, or why. Patients who attend the heart failure clinic at the Royal Brompton, either face-to-face or virtually, will be eligible for our study. They will be provided an information sheet and asked for informed consent. The study consists of 4 short questionnaires (30 questions total) which only takes between 10-15 minutes to complete, this consists of 3 previously validated questionnaires and one bespoke questionnaire related to their digital tool use. The investigators aim to recruit 130 patients to help us better understand how many NHS patients with heart failure access digital tools, which ones are most often used, and how this relates to their health literacy, digital health literacy and overall attitude to their health condition and management. The investigators aim to describe different digital subgroups of patients and will use this information to help inform local and national policy around digital support for people living with heart failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 29, 2022

Last Update Submit

March 28, 2023

Conditions

Keywords

Digital technologyDigital literacyPatient activation measures

Outcome Measures

Primary Outcomes (4)

  • Proportions of digital tool use

    Proportions of study participants using a variety of digital tools to access information about heart failure including websites, mobile applications and social media. The frequency of use and reasons for use.

    6 months

  • Correlation of digital tool use with demographics

    The correlation between digital tool use and several patient demographics including age in years, gender, highest educational level in grade, estimated income in British pounds and ethnic group.

    6 months

  • Correlation of digital tool use with measures of patients' heart failure

    The correlation between digital tool use and left ventricular ejection fraction in percentage, time from diagnosis of heart failure in months, New York Heart Association classification of heart failure (NYHA) and number of comorbidities.

    6 months

  • Correlation of digital tool use with validated questionnaires

    The correlation between digital tool use and health literacy (as measured by the validated AAHLS questionnaire - All aspects of health literacy scale). The correlation between digital tool use and digital health literacy (as measured by the validated eHEALS questionnaire). The correlation between digital tool use and patient activation (as measured by the validated PAM®). Patient activation is the knowledge, skills and confidence to manage one's health and healthcare.

    6 months

Study Arms (1)

Digital tool Survey

Sequential patients from the 4 heart failure clinics at our institution will be offered to take part in the study.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a study of outpatients with a diagnosis of heart failure, regardless of ejection fraction.

You may qualify if:

  • Any patient who attends one of the heart failure clinics at the Royal Brompton hospital with a diagnosis of heart failure will be considered for the study.

You may not qualify if:

  • Unable to complete a questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Guy's and St Thomas' foundation NHS trust

London, United Kingdom

Location

King's college NHS foundation trust

London, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Martin Cowie

    Royal Brompton hospital, part of Guys and St Thomas' hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

January 4, 2022

Primary Completion

December 1, 2022

Study Completion

March 28, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations