Heart Failure
Conditions
Interventions
To promote symptom awareness, participants are asked to periodically complete the Heart Failure Physical Sensation Scale. Symptom assessments using ePRO are requested once a week for the first month a
Sponsors
Teikyo Heisei University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.18 years of age or older 2.Diagnosed with heart failure and currently hospitalized 3.Written consent has been obtained from the patient 4.Able to enter ePRO data via Bring Your Own Device
Exclusion criteria
Exclusion criteria: 1. Has cognitive difficulties that make it hard to complete the PRO questionnaire 2. Has mental health issues that make it hard to complete the PRO questionnaire 3. Does not speak Japanese as a native language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This trial will use ePRO to screen for heart failure related symptoms over time and will conduct a randomized controlled trial to evaluate the clinical utility of promoting symptom awareness, using standard care which does not promote symptom awareness as the control. For the two groups the intervention group, which received HFSPS to promote symptom awareness, and the control group general linear model will be fitted using the KCCQ12 overall summary score at 3 and 6 months as the response variable, and group, time, the interaction between group and time, and the baseline KCCQ12 overall summary score as explanatory variables. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the KCCQ12 subscales Physical Limitation, Symptom Frequency, Quality of Life, and Social Limitation using general linear models and the same methodology as in the primary analysis.Estimate and test for differences between the intervention and control groups in the BMQ TNS, TCS, and NCD scores at 24 weeks postdischarge.Summarize the proportion of HFSPS entries in the intervention group using descriptive statistics.Estimate and test for differences in the EFHScBS score at 24 weeks postdischarge between the intervention and control groups.Estimate and test for differences in DA and DAOH between the intervention and control groups.The time to first readmission for heart failure or any cause will be estimated using the Kaplan Meier method for survival analysis, and group comparisons will be performed using the logrank test. Additionally, the hazard ratio and 95 percent confidence interval will be calculated using the Cox proportional hazards model to evaluate the hazard ratio between groups. | — |
Countries
Japan
Contacts
Public ContactMasanori SUZUKI
Teikyo Heisei University Faculty of Pharmaceutical Sciences
Outcome results
None listed