none, only assessment at different time points
Otherassessment at different time points
NCT Number: NCT04063982
The aim of the observational multicenter trial encompasses the comparison of estimation of the long-term prognosis (functional and cognitive outcomes, quality of life) after intracerebral and subarachnoid hemorrhages assessed by clinical scores, treating physicians and nurses. The scores and the assessment of the treating physicians and nurses are recorded on admission, at 7 and 14 days after symptom onset.
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Notify Me18 year and older
All sexes
Observational
Charité University Hospital, Berlin, Germany
The physicians and nurses responsible for the individual patient's care will be given a questionaire. They are asked to estimate the functional and cognitive status as well as quality of life of their patient. The patient with intracerebral hemorrhage and subarachnoid hemorrhage is examined and assessed with respective established and validated prognostic scores and models at the same time points.
The actual prognosis is assessed by telephone interview and questionaires at 3 and 6 months, either from the patient or his/her caretaker.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
assessment at different time points
Time frame: 6 months
Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)
Time frame: 3 months
Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)
Time frame: 6 months
Modified Rankin Scale dichotomized 0-3 (good functional outcome) versus 4-6 (poor functional outcome)
Time frame: 3 months
Modified Rankin Scale dichotomized 0-3 (good functional outcome) versus 4-6 (poor functional outcome)
Time frame: 3 and 6 months
Short Form Health Survey Short Form (SF)-36: Out of the 36 items, the following 8 subscales/dimensions are assessed and compared to the values of the normal Population: physical function (10 items), physical role function (4 items), physical pain (2 items), general perception of health status (5 items), vitality (4 items), social function and Integration (2 items), emotional role functioning (3 items), psychological well-being (5 items), Change of health status, compared to one year ago (1 item). The first 4 dimensions can be summarized to the physical sum scale, the second 4 items comprise the psychological sum scale.
Time frame: 3 and 6 months
Sickness Impact Profile: 189 items in 14 topic categories. The physical dimension score is obtained by adding the scale values for each item checked within categories body care and movement, mobility, and ambulation, dividing by the maximum possible dysfunction score for these categories, and then multiplying by 100; the psychosocial dimension score is obtained by adding the scale values for each item checked within categories emotional behavior, social interaction, alterness behavior, and communication, dividing by the maximum possible dysfunction score for these categories, and then multiplying by 100. The scores for the remaining categories are always calculated individually. The overall score for the SIP is calculated by adding the scale values for each item checked across all categories and dividing by the maximum possible dysfunction score for the SIP. This figure is then multiplied by 100 to obtain the SIP overall score.
Time frame: 3 and 6 months
Telephone Interview for Cognitive Status: During the telephone interview scores for 22 questions are obtained and added to a total score. The qualitative interpretive ranges are 33-41: cognitive impairment unlikely; 26-32 cognitive impairment may be or may not be present dependent on patients's age, education, history, etc.; 21-25: mild cognitive impairment; </=20: moderate to severe cognitive impairment.
University of Leipzig
Other
Acronym: DON´T-PERISH
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