SYMPACT

  • Research type

    Research Study

  • Full title

    Exploring the interaction between symptom burden and burden of treatment in patients with chronic heart failure (SYMPACT): A sequential explanatory mixed methods study.

  • IRAS ID

    247773

  • Contact name

    Rosalynn Austin

  • Contact email

    r.c.austin@soton.ac.uk

  • Sponsor organisation

    University of Southampton

  • Duration of Study in the UK

    2 years, 3 months, 1 days

  • Research summary

    Patients with chronic heart failure have debilitating and progressive symptoms. Key to improving outcomes is engagement with ‘self-management’ (tasks such as: taking medications, monitoring symptoms, etc.). Patients struggle with these tasks, leading to worsening illness and poorer quality of life. The concept, ‘burden of treatment’, describes this workload and its impact on patients’ lives. It suggests, the balance between the treatment workload and their capability to manage is crucial. If burden of treatment is lessened it may improve self-management and quality of life.

    Burden of treatment argues that symptom burden is a separate concept. But, symptoms in heart failure have been linked to changes in physical, cognitive, and emotional function that may make completing the self-management tasks harder. This may also alter their burden of treatment.

    SYMPACT aims to examine the interaction between symptoms and burden of treatment in patients with chronic heart failure. Adults with chronic heart failure, able and willing to participate, whose health care is based in one of the participating NHS Trusts, will be invited to take part in this study.

    The first phase of SYMPACT, will invite patients to complete a single survey. They will be asked to share health information and complete three validated questionnaires. This can be completed at a health trust or in their home, it is their choice. The questionnaires capture their experience of symptoms and of managing their heart condition. Patients in Phase I may be invited to participate in Phase II. Phase II consists of a single conversation, a ‘semi-structured interview’, where everyone will be asked similar questions. This will invite patients to share more of their experiences and elaborate on their responses from the questionnaires.

    The analysis of the data from Phase I and II, aims to clarify if symptoms alter the patients’ burden of treatment. This is the first study to explore this relationship in chronic heart failure and may identify factors which could lessen burden of treatment.

  • REC name

    East Midlands - Nottingham 1 Research Ethics Committee

  • REC reference

    18/EM/0339

  • Date of REC Opinion

    7 Nov 2018

  • REC opinion

    Further Information Favourable Opinion