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Exploring the interaction between symptom burden and burden of treatment in patients with chronic heart failure

Exploring the interaction between symptom burden and burden of treatment in patients with chronic heart failure: a sequential explanatory mixed methods study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11011943
Enrollment
350
Registered
2019-02-28
Start date
2018-11-28
Completion date
Unknown
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure Circulatory System Heart failure

Interventions

The design chosen for this study allows the researcher to use validated tools to measure both symptoms and burden of treatment in patients with chronic heart failure. However, as the interaction betwe
a) sent an invite letter and patient information leaflet or b) given a patient information leaflet, whichever is most appropriate. They will then be given an appropriate amount of time to read and con

Sponsors

University of Southampton
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Diagnosis of Heart Failure (preserved and reduced ejection fraction) at least 6 months prior to consent (supported by any conventional imaging modality). 3. New York Heart Association (NYHA) class II - IV 4. On active treatment for heart failure (minimum of one evidenced based heart failure medication and a diuretic) 5. Life expectancy of at least of 12 months 6. Able and willing to complete study questionnaires 7. Able and willing to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Clinical plan or past occurrence of treatment through heart transplant 2. Severe cognitive concerns, in the opinion of the investigator, which would substantially limit the individual’s ability to report on what it is like to live with heart failure and manage the condition

Design outcomes

Primary

MeasureTime frame
1. Symptom Burden is measured using the Heart Failure Symptom Survey (HFSS) at a single time point. 2. Quality of Life is measure using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) at a single time point 3. Burden of Treatment is measure using the Patient Experience of Treatment and Self-care (PETS) questionnaire at a single time point

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026