DIGITAL-HF - Digital Tools in Heart Failure - a Survey of Patient Usage (DIGITAL-HF) (DIGITAL-HF)

Digital Tools in Heart Failure - a Survey of Patient Usage (DIGITAL-HF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • London, United Kingdom
    • Guy's and St Thomas' foundation NHS trust
  • London, United Kingdom
    • King's College NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Unable to complete a questionnaire

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Digital tool Survey; Sequential patients from the 4 heart failure clinics at our institution will be offered to take part in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Investigators: Principal Investigator: Martin Cowie, Royal Brompton hospital, part of Guys and St Thomas' hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Digital technology; Digital literacy; Patient activation measures
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 307636

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No