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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00006829 |
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Date of registration:
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02/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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E-health information system for an advanced nursing care process
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Scientific title:
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E-health information system for an advanced nursing care process |
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Date of first enrolment:
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06/10/2014 |
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Target sample size:
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132 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00006829 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: other
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Virpi
Hantikainen |
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Address:
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Rosenbergstrasse 59
9001
St.Gallen
Switzerland |
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Telephone:
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00 41 (0) 71 226 15 29 |
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Email:
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virpi.hantikainen@fhsg.ch |
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Affiliation:
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FHS St.GallenHochschule für Angewandte WissenschaftenInstitut für Angewandte Pflegewissenschaft |
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Name:
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Heidrun
Gattinger |
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Address:
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Rosenbergstrasse 59
9001
St. Gallen
Switzerland |
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Telephone:
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00 41(0)71 226 15 22 |
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Email:
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heidrun.gattinger@fhsg.ch |
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Affiliation:
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FHS St. GallenHochschule für Angewandte WissenschaftenInstitut für Angewandte Pflegewissenschaft |
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Key inclusion & exclusion criteria
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Inclusion criteria: Elderly resident:Dementia/cognitively constrained elderly resident (medical diagnose / assessment by nurses), sleeping disorder (assessment by nurse), written informed consent (for a person who fully lacks the capacity to consent, informed consent will be obtained indirectly through proxy decision maker)
Case discussions: nurse’s written informed consent
Exclusion criteria: Elderly resident: end of life care,
no written informed consent.
Nurse: no written informed consent
Age minimum:
65 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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dementia, cognitive disabilities, sleep
F03
G47
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Sleep disorders
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Unspecified dementia
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Intervention(s)
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Group 1: Training and case discussion on the issue of sleep and dementia, without application of the mobility monitoring
Group 2: The application of the mobility monitoring over 5 nights, in combination with training on the issue of sleep and dementia and case discussion
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Primary Outcome(s)
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Sleep quality will be measured by Swiss version of neuropsychiatric inventory for nursing home (NPI-NH)- area K sleep, Essener questionnaire on age and sleepiness EFAS, one item of Pittsburgh Sleep Quality Index (PSQI) and Mobility Monitor at baseline t0, after 6 weeks t1 and after 6 months t2.
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Secondary Outcome(s)
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Decubitus ulcer, falls, nurses’ work load (questionnaire for „Belastungserleben der Pflegenden von Menschen mit Demenz), quality of life of elderly residents (German version of 15D instrument of QoL) and cost-benefit analysis at baseline t0, after 6 weeks t1 and after 6 months t2.
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Source(s) of Monetary Support
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Compliant Concept
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Kommission für Technologie und Innovation KTITeam Enabling Sciences
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Ethics review
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Status: Approved
Approval date: 15/09/2014
Contact:
Ethikkommission des Kantons St.Gallen Kantonsspital St.Gallen [Kantonale Ethikkommission St. Gallen CH]
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