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

Heart Failure Clinical Trial

— DIGITAL-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313880
• Other study ID #: 307636
• Status: Completed
• Start date: January 4, 2022
• Est. completion date: March 28, 2023

Study information

• Verified date: March 2023
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: March 28, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' foundation NHS trust	London
United Kingdom	King's college NHS foundation trust	London
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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