SYMPERHEART. Supporting symptom perception in persons living with heart failure

Conditions

Chronic heart failure Circulatory System

Santos GC, Liljeroos M, Tschann K, Denhaerynck K, Wicht J, Jurgens CY, Hullin R, Schäfer-Keller P.

2023-10-041 citations

SYMPERHEART: an intervention to support symptom perception in persons with heart failure and their informal caregiver: a feasibility quasi-experimental study protocol

Gabrielle Cécile Santos, Maria Liljeroos, Roger Hullin, Kris Denhaerynck, Justine Wicht et al. (7 authors)

BMJ Open2021-07-018 citations

10.1136/bmjopen-2021-052208

Interventions

SYMPERHEART is an evidence-based intervention that targets heart failure symptom perception. The intervention combines body observation (i.e. symptom monitoring on paper graphs based o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient participants: 1. HF adults =18 years old 2. Confirmed HF diagnostic 3. NYHA class II-IV 4. Speaking French or German 5. Being followed by home-based care 6. Providing written informed consent to participate Informal caregiver: 1. Adult =18 years old 2. Identified by the participating HF patient as an informal caregiver 3. Either living with the patient, or having at least weekly contact 4. Speaking French or German 5. Providing written informed consent to participate. Nurse sample: 1. Registered/diploma nurses delivering the intervention 2. Fluent in French or German 3. Designated by the home care nurse manager

Exclusion criteria

Exclusion criteria: Patient participants: 1. Suffering from immediately life threatening or terminal illness 2. Being already enrolled in an interventional study supporting heart failure self-care 3. Clinical instability necessitating a hospitalization 4. Subject to cognitive impairment that would preclude written informed consent Informal caregiver: 1. Subject to cognitive impairment that would preclude written informed consent 2. Suffering from immediately life threatening or terminal illness 3. Refusal by the HF person to involve an informal caregiver in the study Nurse sample: 1. Not having attended to the preparation sessions of the intervention

Design outcomes

Primary

Measure	Time frame
1. Intervention feasibility measured by : 1.1. Time needed to recruit participants and to deliver the intervention measured using excel files to report time dedicated to this work throughout the study 1.2. Number of eligible participants identified each week and month measured using Redcap® platform that allows to store data on a dedicated secured server and reported on the study flow diagram each month and at the end of the study 1.3. Extend of intervention delivered as described in the study manual (intervention fidelity) measured using fidelity checklists filled by the nurses after each face-to-face interaction with the participants 2. Intervention acceptability measured by: 2.1. Number of eligible participants, including informal caregivers, consenting to participate each week/month, and reasons for non-participation measured using Redcap® platform that allows to store data on a dedicated secured server and reported on the study flow diagram each month and at the end of the study 2.2. Number of participants retained during the 3-month study period; number of participants stopping prematurely and reason for stopping, where available measured using Redcap® platform that allows to store data on a dedicated secured server and reported on the study flow diagram each month and at the end of the study 2.3. SYMPERHEART intervention’s acceptability for participants (i.e., HF persons, informal caregivers and nurses delivering the intervention) measured using the Treatment Acceptability and Preferences (TAP) measure adapted for the SYMPERHEART study at 30 days for HF persons and informal caregivers and at the end of the study for nurses 2.4. Extent of HF persons and informal caregivers’ responsiveness in the SYMPERHEART monitoring activities and in response to symptoms measured using paper graphs 2.4.1. by the rate of engagement i	—

Measure

Time frame

1. Intervention feasibility measured by : 1.1. Time needed to recruit participants and to deliver the intervention measured using excel files to report time dedicated to this work throughout the study 1.2. Number of eligible participants identified each week and month measured using Redcap® platform that allows to store data on a dedicated secured server and reported on the study flow diagram each month and at the end of the study 1.3. Extend of intervention delivered as described in the study manual (intervention fidelity) measured using fidelity checklists filled by the nurses after each face-to-face interaction with the participants 2. Intervention acceptability measured by: 2.1. Number of eligible participants, including informal caregivers, consenting to participate each week/month, and reasons for non-participation measured using Redcap® platform that allows to store data on a dedicated secured server and reported on the study flow diagram each month and at the end of the study 2.2. Number of participants retained during the 3-month study period; number of participants stopping prematurely and reason for stopping, where available measured using Redcap® platform that allows to store data on a dedicated secured server and reported on the study flow diagram each month and at the end of the study 2.3. SYMPERHEART intervention’s acceptability for participants (i.e., HF persons, informal caregivers and nurses delivering the intervention) measured using the Treatment Acceptability and Preferences (TAP) measure adapted for the SYMPERHEART study at 30 days for HF persons and informal caregivers and at the end of the study for nurses 2.4. Extent of HF persons and informal caregivers’ responsiveness in the SYMPERHEART monitoring activities and in response to symptoms measured using paper graphs 2.4.1. by the rate of engagement i

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Secondary

Measure	Time frame
1. PRO in persons living with HF 1.1. HF self-care measured using the Self-Care of HF Index (SCHFI) v.7.2 at baseline, 30 days and 90 days 1.2. Perception of HF symptom burden measured using the Heart Failure Somatic Perception Scale (HFSPS) v.3 at baseline, 30 days and 90 days 1.3. Health status measured using the Kansas City Cardiomyopathy questionnaire KCCQ-12 at baseline, 30 days and 90 days 2. PRO in informal caregivers 2.1. Caregivers’ contribution to HF self-care will be measured with the Caregiver Contribution to Self-care of HF Index CC-SCHFI v.2 at baseline, 30 days and 90 days 2.2. Caregivers’ burden will be measured with the Zarit Burden Interview at baseline, 30 days and 90 days 3. Clinical outcomes 3.1. Mortality measured using number of deaths occurring during the 90 days after participant enrollment reported in the health records or reported in Serious Advent Event form by the general practitioner 3.2. Hospitalization reason measured using number of hospitalization due to cardiac decompensation and number of hospitalization due to other reason during the 90 days after participant enrollment reported in the health records or reported in Serious Advent Event form by the general practitioner 3.3. Hospitalization length of stay measured using data of admission and date of discharge in case of hospitalization during the 90 days after participant enrollment reported in the health records or reported in Serious Advent Event form by the general practitioner	—

Measure

Time frame

1. PRO in persons living with HF 1.1. HF self-care measured using the Self-Care of HF Index (SCHFI) v.7.2 at baseline, 30 days and 90 days 1.2. Perception of HF symptom burden measured using the Heart Failure Somatic Perception Scale (HFSPS) v.3 at baseline, 30 days and 90 days 1.3. Health status measured using the Kansas City Cardiomyopathy questionnaire KCCQ-12 at baseline, 30 days and 90 days 2. PRO in informal caregivers 2.1. Caregivers’ contribution to HF self-care will be measured with the Caregiver Contribution to Self-care of HF Index CC-SCHFI v.2 at baseline, 30 days and 90 days 2.2. Caregivers’ burden will be measured with the Zarit Burden Interview at baseline, 30 days and 90 days 3. Clinical outcomes 3.1. Mortality measured using number of deaths occurring during the 90 days after participant enrollment reported in the health records or reported in Serious Advent Event form by the general practitioner 3.2. Hospitalization reason measured using number of hospitalization due to cardiac decompensation and number of hospitalization due to other reason during the 90 days after participant enrollment reported in the health records or reported in Serious Advent Event form by the general practitioner 3.3. Hospitalization length of stay measured using data of admission and date of discharge in case of hospitalization during the 90 days after participant enrollment reported in the health records or reported in Serious Advent Event form by the general practitioner

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Countries

Switzerland

Outcome results

None listed