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

Sponsor
Royal Brompton & Harefield NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT05313880
Collaborator
(none)
130
1
5.8
22.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    130 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Digital Tools in Heart Failure - a Survey of Patient Usage (DIGITAL-HF)
    Actual Study Start Date :
    Jan 4, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Digital tool Survey

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

    Outcome Measures

    Primary Outcome Measures

    1. Proportions of digital tool use [6 months]

      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.

    2. Correlation of digital tool use with demographics [6 months]

      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.

    3. Correlation of digital tool use with measures of patients' heart failure [6 months]

      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.

    4. Correlation of digital tool use with validated questionnaires [6 months]

      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 PAMĀ®). Patient activation is the knowledge, skills and confidence to manage one's health and healthcare.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Brompton Hospital London United Kingdom SW3 6NP

    Sponsors and Collaborators

    • Royal Brompton & Harefield NHS Foundation Trust

    Investigators

    • Principal Investigator: Martin Cowie, Royal Brompton hospital, part of Guys and St Thomas' hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Royal Brompton & Harefield NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05313880
    Other Study ID Numbers:
    • 307636
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Royal Brompton & Harefield NHS Foundation Trust
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 14, 2022