Registry Study of the University Neurovascular Network of Saarland and Rhineland-Palatinate on the Multidimensional Assessment of Clinical Course, Quality of Life, and Caregiver Burden in Patients with Stroke or Transient Ischemic Attacks

Registry Study of the University Neurovascular Network of Saarland and Rhineland-Palatinate on the Multidimensional Assessment of Clinical Course, Quality of Life, and Caregiver Burden in Patients with Stroke or Transient Ischemic Attacks - UNN-STREG

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00041099

Enrollment

10000

Registered

2026-07-24

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Stroke, transient ischemic attack (TIA)

Interventions

Group 1: The study investigates the longitudinal disease course of patients with stroke or transient ischemic attack, as well as the burden experienced by their informal caregivers. A multidimensional

Eligibility

Sex/Gender

All

Age

7 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with a diagnosis of stroke or transient ischemic attack (TIA) - Written informed consent provided by the patient or, where applicable, by the patient's parent(s), legal guardian, or legally authorized representative

Exclusion criteria

Exclusion criteria: Age <7 years Patients unable to provide informed consent who do not have a legally authorized representative

Design outcomes

Primary

Measure	Time frame
The primary endpoint is recurrent stroke. Data will be collected at 3, 6, 12, 18, and 24 months after enrollment, followed by annual assessments for an additional three years. Data collection will be based on structured interviews and verified against the patients' medical records.	—

Secondary

Measure	Time frame
Secondary endpoints include measures of quality of life, mood as assessed by the Beck Depression Inventory-II (BDI-II), sleep quality, resilience, and caregiver burden. The following validated instruments will be used: the Stroke-Specific Quality of Life Scale (SS-QOL) to assess stroke-specific quality of life; the EuroQol (EQ-5D and EQ-VAS) to assess generic health-related quality of life; the WHOQOL-BREF to evaluate overall quality of life; the Beck Depression Inventory-II (BDI-II) to assess depressive symptoms; the Multidimensional Fatigue Inventory (MFI); the Pittsburgh Sleep Quality Index (PSQI); the 13-item Resilience Scale (RS-13); the Berlin Social Support Scale (BSSS) to assess perceived social support; the Treatment Expectation Questionnaire (TEX-Q) to evaluate treatment expectations; the Caregiver Strain Index (CSI) to assess caregiver burden; the Life Satisfaction Questionnaire (LiSat-11); and the Screening Scale for Chronic Stress of the Trier Inventory for Chronic Stress (TICS-SSCS). Follow-up assessments will be conducted at 3, 6, 12, 18, and 24 months after enrollment and annually thereafter for an additional three years.	—

Measure

Time frame

Secondary endpoints include measures of quality of life, mood as assessed by the Beck Depression Inventory-II (BDI-II), sleep quality, resilience, and caregiver burden. The following validated instruments will be used: the Stroke-Specific Quality of Life Scale (SS-QOL) to assess stroke-specific quality of life; the EuroQol (EQ-5D and EQ-VAS) to assess generic health-related quality of life; the WHOQOL-BREF to evaluate overall quality of life; the Beck Depression Inventory-II (BDI-II) to assess depressive symptoms; the Multidimensional Fatigue Inventory (MFI); the Pittsburgh Sleep Quality Index (PSQI); the 13-item Resilience Scale (RS-13); the Berlin Social Support Scale (BSSS) to assess perceived social support; the Treatment Expectation Questionnaire (TEX-Q) to evaluate treatment expectations; the Caregiver Strain Index (CSI) to assess caregiver burden; the Life Satisfaction Questionnaire (LiSat-11); and the Screening Scale for Chronic Stress of the Trier Inventory for Chronic Stress (TICS-SSCS). Follow-up assessments will be conducted at 3, 6, 12, 18, and 24 months after enrollment and annually thereafter for an additional three years.

—

Countries

Germany

Contacts

Public ContactYaroslav Winter

Universitätsklinikum des Saarlandes

yaroslav.winter@uks.eu+4968411614107

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026