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

Not Applicable

Completed

• Conditions: Heart failure; Circulatory System

• Registration Number: ISRCTN11011943
• Lead Sponsor: niversity of Southampton

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32940966/ protocol (added 23/09/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35451208/ Results of survey on patient-reported symptoms and burden of treatment (added 24/06/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35945903/ Results of interviews on interaction between symptoms and burden of self-care work (added 12/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-28
• Study Completion: 2020-09-22
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 333

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified