Skip to content

Patient-centered developtment of a holistic care model for people living with heart disease - A quantitative survey of patient preferences

Patient-centered developtment of a holistic care model for people living with heart disease - A quantitative survey of patient preferences - PAELLA-HF Survey

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036900
Enrollment
300
Registered
2025-05-15
Start date
2025-05-13
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50

Interventions

Group 1: Cross-sectional survey among patients with stable, symptomatic heart failure without a Left Ventricular Assist Device (LVAD) (n=150) -Agreement with various approaches to the integration of p

Sponsors

Deutsches Herzzentrum der Charité
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - symptomatic heart faiilure (NYHA II-IV) - no urgent hospitalizations within the last 3 months - regarding Patients with LVAD: implantation was longer than 3 months ago

Exclusion criteria

Exclusion criteria: - insufficient German language proficiency for completing the survey

Design outcomes

Primary

MeasureTime frame
Agreement with various approaches to the integration of palliative care Agreement with the different approaches to the integration of palliative care will be assessed in a survey using a 6-point Likert scale ("Strongly disagree," "Disagree," "Somewhat disagree," "Somewhat agree," "Agree," "Strongly agree"). For the analysis of the primary study endpoint, responses will be dichotomized as follows: No perceived need – “Strongly disagree,” “Disagree,” or “Somewhat disagree”; Perceived need – “Somewhat agree,” “Agree,” or “Strongly agree.” Agreement with each individual approach will be reported as prevalence in percent with a 95% confidence interval. Given our sample size of n=300, the two-sided 95% confidence intervals are expected to have a maximum width of ±6 percentage points in the statistically least favorable scenario of 50% prevalence. This level of precision is considered sufficient for the context of this study.

Secondary

MeasureTime frame
- Differences in the prevalence and extent of agreement with individual approaches to the integration of palliative care between selected subgroups (men vs. women, age above vs. below median, left ventricular assist device (LVAD) therapy vs. no LVAD therapy, KCCQ-OSS above vs. below median, PHQ-4 score above vs. below median, fulfillment of the ESC-HFA definition of advanced heart failure, fulfillment of the I-NEED-HELP criteria, migration background vs. no migration background, household income above vs. below median, as well as stratification by other social determinants of health). -Predictors of agreement with individual approaches to palliative care in univariable and multivariable logistic regression analyses. The following independent variables will be tested: gender, age, LVAD therapy (yes/no), quality of life measured by KCCQ-OSS, quality of life measured by IPOS, time since heart failure diagnosis (in years), if applicable, time since LVAD implantation, PHQ-4 score above vs. below median, fulfillment of the ESC-HFA definition of advanced heart failure, fulfillment of the I-NEED-HELP criteria, NYHA classification, symptom burden, history of prolonged intensive care therapy, history of complications, social determinants of health (migration background, education level, income, financial distress, loneliness), functional status, prognostic awareness, comorbidities. -Effect of the term "palliative care" on the likelihood of participating in a palliative care service. Agreement to participate in the respective offers will be measured using 6-point Likert scales and dichotomized as described above. Agreement with the individual approaches will be reported as prevalence in percent with a 95% confidence interval. -Prevalence of having designated a healthcare proxy or having completed advance directives

Countries

Germany

Contacts

Public ContactMoritz Blum

Deutsches Herzzentrum der Charite

moritz.blum@charite.de030 4593 2000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026