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1.
Pilot Feasibility Stud ; 9(1): 168, 2023 Oct 04.
Article in English | MEDLINE | ID: mdl-37794511

ABSTRACT

BACKGROUND: Symptom perception is an important process of heart failure (HF) self-care that persons with HF need in order to master self-care management. It also leads to better patient outcomes. Symptom perception consists of body observation and analysis, which are both challenging. We aimed to test the feasibility, acceptability, and outcome responsiveness of a novel intervention (SYMPERHEART) delivered to persons with HF with their informal caregiver. METHODS: We designed SYMPERHEART as a complex evidence-informed education and support intervention targeting body observation and analysis. We conducted a feasibility quasi-experimental study with a single group pre-post-test design. We included three subsamples: persons with HF receiving home-based care, their informal caregivers exposed to SYMPERHEART, and home-care nurses who delivered SYMPERHEART during 1 month. We assessed feasibility by recruitment time, time to deliver SYMPERHEART, eligibility rate, and intervention fidelity. We assessed acceptability by consent rate, retention rate, persons with HF engagement in body observation, and treatment acceptability. Outcome responsiveness was informed by patient-reported (PRO) and clinical outcomes: HF self-care and the informal caregivers' contribution to HF self-care, perception of HF symptom burden, health status, caregivers' burden, and HF events. We performed descriptive analyses for quantitative data and calculated Cohen's d for PROs. A power analysis estimated the sample size for a future full-scale effectiveness study. RESULTS: We included 18 persons with HF, 7 informal caregivers, and 9 nurses. Recruitment time was 112.6 h. The median time to deliver SYMPERHEART for each participant was 177.5 min. Eligibility rate was 55% in persons with HF. Intervention fidelity revealed that 16 persons with HF were exposed to body observation and analysis. Consent and retention rates in persons with HF were 37.5% and 100%, respectively. Participants engaged actively in symptom and weight monitoring. Treatment acceptability scores were high. Symptom perception and informal caregivers' contribution to symptom perception were found to be responsive to SYMPERHEART. We estimate that a sample size of 50 persons with HF would be needed for a full-scale effectiveness study. CONCLUSIONS: SYMPERHEART was found to be feasible and acceptable. This feasibility study provides information for a subsequent effectiveness study. TRIAL REGISTRATION: ISRCTN. ISRCTN18151041 , retrospectively registered on 4 February 2021, ICTRP Search Portal.

2.
Cancers (Basel) ; 14(5)2022 Feb 26.
Article in English | MEDLINE | ID: mdl-35267536

ABSTRACT

Background: Head and neck cancer (HNC) patients experience distressing symptoms that can significantly impact their health-related quality of life (HRQoL). We analyzed the implementation of a nurse-led consultation (NLC) and explored potential associations with symptom burden in HNC patients. Methods: We retrospectively analyzed routinely collected data to describe the implementation of the nurse-led interventions and the evolution of the M.D. Anderson Symptom Inventory scores as patient-reported outcome measures (PROMs). Patients who received routine care (n = 72) were compared with patients in the NLC group (n = 62) at a radiation oncology unit between 2017 and 2019. PROMs were measured at T0 (between simulation and the first week of radiotherapy), T1 (week 3−4), and T2 (week 5−6). Results: Screening for nutrition, smoking, oral cavity status, and capacity for swallowing/chewing, but not for pain, was applied in >80% of patients in the NLC group from T0 to T1. Education (16%) and care coordination (7%) were implemented to a lesser extent. Symptom burden increased over time with no significant differences between groups. Conclusions: The nurse-led consultation was not associated with symptom burden over time. A larger implementation study including a detailed process evaluation, larger sample size, and a focus on long-term effects is needed.

3.
BMJ Open ; 11(7): e052208, 2021 07 27.
Article in English | MEDLINE | ID: mdl-34315799

ABSTRACT

INTRODUCTION: Symptom perception in heart failure (HF) has been identified as crucial for effective self-care, and is related to patient and health system outcomes. There is uncertainty regarding the feasibility and acceptability of symptom perception support and doubts regarding how to include informal caregivers. This study aims to test the feasibility, acceptability and outcome responsiveness of an intervention supporting symptom perception in persons with HF and their informal caregiver. METHODS AND ANALYSIS: A feasibility study with a quasi-experimental pretest and post-test single group design is conducted. The convenience sample consists of 30 persons with HF, their informal caregivers and six nurses. SYMPERHEART is an evidence-informed intervention that targets symptom perception by educational and support components. Feasibility is measured by time-to-recruit; time-to-deliver; eligibility rate; intervention delivery fidelity rate. Acceptability is measured by rate of consent, retention rate, treatment acceptability and the engagement in the intervention components. Outcome responsiveness includes: HF self-care (via the Self-care of Heart Failure Index V.7.2); perception of HF symptom burden (via the Heart Failure Somatic Perception Scale V.3); health status (via the Kansas City Cardiomyopathy Questionnaire-12); caregivers' contribution to HF self-care (via the Caregiver Contribution to Self-Care of Heart Failure Index 2); caregivers' burden (via the Zarit Burden Interview). Clinical outcomes include HF events, hospitalisation reason and length of hospital stay. Descriptive statistics will be used to report feasibility, acceptability, patient-reported outcomes (PRO) and clinical outcomes. PRO and caregiver-reported outcome responsiveness will be reported with mean absolute change and effect sizes. ETHICS AND DISSEMINATION: The study is conducted according to the Declaration of Helsinki. The Human Research Ethics Committee of the Canton of Vaud, Switzerland, has approved the study. Written informed consent from persons with HF and informal caregivers are obtained. Results will be published via peer reviewed and professional journals, and further disseminated via congresses. TRIAL REGISTRATION NUMBER: ISRCTN18151041.


Subject(s)
Caregivers , Heart Failure , Feasibility Studies , Heart Failure/therapy , Humans , Perception , Quality of Life , Switzerland
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