Symptom trajectories in patients with atrial fibrillation and pulmonary embolism and oral anticoagulant therapy and their relatives - A longitudindal study

Symptom trajectories in patients with atrial fibrillation and pulmonary embolism and oral anticoagulant therapy and their relatives - A longitudindal study - SOPHIA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035378

Enrollment

490

Registered

2024-11-12

Start date

2024-11-19

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I48 I26.0

Interventions

Group 1: Patients with atrial fibrillation or pulmonary embolism and oral anticoagulation are requested to fill out paper-based patient-reported outcome questionnaires about symptomtrajectories at thr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patient: - Diagnose of atrial fibrillation or pulmonary embolism (with or without deep vein thrombosis) - Indication and begin of an oral anticoagulation therapy (Factor Xa-Inhibitor, Thrombin Inhibitor or vitamin-k-antagonist) - care at the ward and not at a intensive care unit - Minimum age > 18 years, sufficient language skills to fill out the questionnaire - Written informed consent Relatives: - Named by the patient as a potential relative/life partner. - Minimum age > 18 years, sufficient language skills to fill out the questionnaire - Written informed consent

Exclusion criteria

Exclusion criteria: Patient: - palliative care situation - Lack of ability to give written consent Relatives: - Unwillingness to participate and lack of ability to give written consent

Design outcomes

Primary

Measure	Time frame
Focus on Health related quality of life Patients with Artrial Fibrillation: Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) Patients with Pulmonray Embolism: Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL) - German Version and Short Form-12 Health Survey (SF 12) - German Version Relatives: Focus on Health related quality of life with the questionnaire: Short Form-12 Health Survey (SF 12) - German Version	—

Measure

Time frame

Focus on Health related quality of life Patients with Artrial Fibrillation: Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) Patients with Pulmonray Embolism: Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL) - German Version and Short Form-12 Health Survey (SF 12) - German Version Relatives: Focus on Health related quality of life with the questionnaire: Short Form-12 Health Survey (SF 12) - German Version

—

Secondary

Measure	Time frame
Both groups with focus on: Symptoms of Anxiety and Depression: Hospital Anxiety and Depression Scale - German Version (HADS-D) Social support: Social Support Questionnaire -Short form (F-SozU K-14)	—

Countries

Germany

Contacts

Public ContactChristiane Kugler

Medizinische Fakultät - Institut für Pflegewissenschaft - Albert-Ludwigs-Universität Freiburg

christiane.kugler@uniklinik-freiburg.de49-761 270 64820

Outcome results

None listed

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