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Identification of cut points for sleep disturbances in a validated measure for children with life-limiting conditions

Conditions
Children and adolescents with life-limiting conditions and severe psychomotor impairment along with impaired communication
Registration Number
DRKS00011884
Lead Sponsor
niversität Witten Herdecke
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
70
Inclusion Criteria

Children and adolescents with life-limiting conditions and severe psychomotor impairment, planned duration of inpatient stay more than 10 days, parents: Comprehensive understanding of the German language, informed consent

Exclusion Criteria

Life expectancy <4 weeks

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Identification of cut points for SNAKE (first aim); hereto parents complete the SNAKE during their child´s inpatient stay; based on the observation of the patient (first 10 days after admission) an interdisciplinary expert group will deliver an consensus about the existence of sleep disturbances („gold standard); data analysis: ROC analysis with the index test „SNAKE and the reference test „expert consensus
Secondary Outcome Measures
NameTimeMethod
Testing des SNAKE´s sensitivity to change archieved by a clinical intervention (second aim) and definition of clinically relevant changes (third aim); hereto follow-up assessment 3 weeks after discharge; data analysis: Paired t-test for differences between SNAKE scores before and after the children´s inpatient stay (second aim) and ROC analysis with index test „change in SNAKE and reference test „parents´overall impression of change in their children´s sleep disturbance)
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