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Semax

ACTH(4-10) analogue, Heptapeptide SEMAX

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Studies 172
Trials 37
Recruiting OBSERVATIONAL NCT06443268

Cerebrovascular Disease: Quality of Life (CODE: QoL)

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The goal of this observational study is to learn about quality of life, stress and caregiver burden in patients with stroke and their caregivers. The main question is: • to discover the factors associated with quality of life and stress in patient-caregiver dyads. Participants will be asked to fill out questionnaires and agree to provide a hair sample (in order to measure stress hormones in hair) and consent to use of their routine clinical and laboratory data. Researchers will compare a group of participants without stroke to establish a comparable baseline.

Detailed Description

Introduction/Background In Switzerland, approximately 21,000 people suffer a stroke each year. Stroke causes neurological impairments for those affected and brings about a sudden change in their life situation. The relatives of stroke patients receive new social roles and are challenged in a new way by the morbidity of the affected person, leading to a change in their quality of life and aggravation of stress. Unlike chronic diseases, a stroke occurs suddenly, so relatives have no opportunity to gradually adapt to the new living circumstances or to deal with the new psychosocial roles and demands beforehand. To what extent the daily life of patients and their relatives changes and what impact this has on their quality of life and stress has not been systematically investigated in Switzerland thus far. Aims and significance of the project The aim of the project is to systematically assess the quality of life and stress, as well as to capture stress biomarkers in stroke patients and their relatives. The investigators plan to conduct sequential measurements of quality of life and stress hormones at multiple time points over 12 months. The goal is in particular to uncover the relationships between the extent of patients' impairments, their quality of life, and stress in affected individuals and their relatives. This is a first-time project with the goal of learning more about stressors and biological relationships. This will create the basis for a multimodal intervention to improve the quality of life of those affected and their relatives, which will be investigated in a follow-up project. Methods The Investigators plan a prospective study with a survey of stroke patients and their relatives regarding their quality of life in everyday life. It will also be examined, how multiple stress biomarkers (which will be determined in blood and hair) are related to quality of life and stress and which clinical factors have a positive and negative influence on the well-being of patients and their relatives.

Interventions

Name: questionnaire, hair samples, blood samples, clinical exam
Type: DIAGNOSTIC_TEST
Description: The following parameters will be sequentially assessed in caregivers and patients (baseline, at 3 months and at 12 months): 1) quality of life / functioning will be determined through questionnaires (SF-36, EQ-5DL, ECOG (Eastern Cooperative Oncology Group) / Karnofsky, Barthel Index, ICIQ) 2) stress levels \& anxiety levels, caregiver burden will be assessed by the following questionnaires: Distress Thermometer, SBQ-G, GAD-7, PHQ-9, PSS-10, ZBI, PAC. Cortisol will be measured in hair to indicate stress within the past 3 months \[18\]. Fasting glucose, lipid profiles and HbA1c along with blood count, sodium, potassium, creatinine, TSH (thyroid-stimulating hormone) will be measured in routine blood samples from patients at the time of clinical checkups. Blood pressure, pulse and BMI will be determined during clinical visit in patients and additionally in caregivers.

Primary Outcomes

Measure: Quality of Life as assessed via Short Form - 36 (SF-36)
TimeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Description: will be assessed using Short Form - 36 (SF-36) Multi-item scale with 8 domains assessing health related quality of life: * limitations in physical activities * limitations in social activities * limitations in usual role activities because * pain * limitations in social role activities * vitality * overall mental health * overall health Domains are scored seperately; Values span from 0 to 100, higher values indicate fewer limitations

Trial Information

NCT ID

NCT06443268

Status

Recruiting

Study Type

OBSERVATIONAL

Sponsor

University of Zurich

Last Updated

December 15, 2025