Back to resultsDaily Sleep Enhancement for Hospitalized People With Dementia Following a Nursing Protocol
Primary Purpose
Sleep, Dementia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
daily sleep enhancement nursing protocol
Sponsored by
About this trial
This is an interventional prevention trial for Sleep focused on measuring geriatric nursing
Eligibility Criteria
Inclusion Criteria:
- diagnosis of dementia of any severity and type
- Allocation to geriatric rehabilitation treatment
Exclusion Criteria:
- sleep related respiratory or moving related disorders or Parasomnia
- delirium
- end of life care
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
daily sleep enhancement nursing protocol
usual nursing care
Arm Description
A 7 step nursing protocol. Each step is daily provided to the demented patient through a nurse by bedtime. Step 1: serve a late snack Step 2: evening care (brush teeth, get pyjama on, go to toilette) Step 3: note and treat physical circumstances that restrain sleep (pain, obstipation,...) Step 4: ensure comfortable position abed Step 5: assist to eliminate stressful situation (calm, reorientating conversation) Step 6: turn off the light Step 7: care for a silent environment (turn off Television, radio and "do not disturb"-sign at the door)
Outcomes
Primary Outcome Measures
Bedtime in minutes
Protocol of daily bedtime
Secondary Outcome Measures
Sleeps through the night consistently, 5 point ordinal scale from "severe compromised" to "not compromised"
Subitem of the Outcome 'Sleep' from the Nursing Outcome Classification (NOC)
Scale:
severe compromised
substantial compromised
moderate compromised
mild compromised
not compromised
Inappropriate napping, 5 point ordinal scale ranging from "sever" to "none"
Subitem of the Outcome 'Sleep' from the Nursing Outcome Classification (NOC)
Scale:
severe
substantial
moderate
mild
none
Cognitive performance (Mini-mental-status-test score)
Mini-mental-status-test score (range 0-30). Any score greater than or equal to 24 points (out of 30) indicates a normal cognition.
Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment
Physical performance measured with the Handgrip strength test
Handgrip strength in Pascal
Use of drugs promoting sleep (sedative neuroleptics, hypnotics, sedative antidepressant in the time between 18:00-24:00) (nominal variable: yes or no)
Medical charts review for sedative neuroleptics (e.g. Quetiapine, Haloperidol), sedative antidepressives (e.g. Trazodon), hypnotics present (Benzodiazepines, benzodiazepine-like drugs) in the time between 18:00-24:00 (nominal variable: yes or no )
Medical chart review for discharge domicile after hospitalisation (nursing home, home, other institution, other)
Domicile after hospital discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02953574
Brief Title
Daily Sleep Enhancement for Hospitalized People With Dementia Following a Nursing Protocol
Official Title
Daily Sleep Enhancement for Hospitalized People With Dementia Following a 7 Step Nursing Protocol: a Quasi-experimental Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
August 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if the daily performance of a 7 step bedtime nursing protocol for hospitalized people living with dementia is feasible and if it has an effect on bedtime and daytime variables.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Dementia
Keywords
geriatric nursing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
daily sleep enhancement nursing protocol
Arm Type
Experimental
Arm Description
A 7 step nursing protocol. Each step is daily provided to the demented patient through a nurse by bedtime.
Step 1: serve a late snack Step 2: evening care (brush teeth, get pyjama on, go to toilette) Step 3: note and treat physical circumstances that restrain sleep (pain, obstipation,...) Step 4: ensure comfortable position abed Step 5: assist to eliminate stressful situation (calm, reorientating conversation) Step 6: turn off the light Step 7: care for a silent environment (turn off Television, radio and "do not disturb"-sign at the door)
Arm Title
usual nursing care
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
daily sleep enhancement nursing protocol
Primary Outcome Measure Information:
Title
Bedtime in minutes
Description
Protocol of daily bedtime
Time Frame
Daily for up to 14 days from date of giving informed consent to hospital discharge
Secondary Outcome Measure Information:
Title
Sleeps through the night consistently, 5 point ordinal scale from "severe compromised" to "not compromised"
Description
Subitem of the Outcome 'Sleep' from the Nursing Outcome Classification (NOC)
Scale:
severe compromised
substantial compromised
moderate compromised
mild compromised
not compromised
Time Frame
Every second day for up to 14 days from date of giving informed consent to hospital discharge
Title
Inappropriate napping, 5 point ordinal scale ranging from "sever" to "none"
Description
Subitem of the Outcome 'Sleep' from the Nursing Outcome Classification (NOC)
Scale:
severe
substantial
moderate
mild
none
Time Frame
Every second day for up to 14 days from date of giving informed consent to hospital discharge
Title
Cognitive performance (Mini-mental-status-test score)
Description
Mini-mental-status-test score (range 0-30). Any score greater than or equal to 24 points (out of 30) indicates a normal cognition.
Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment
Time Frame
Once in first three days after giving informed consent and another time 7 or 14 days later
Title
Physical performance measured with the Handgrip strength test
Description
Handgrip strength in Pascal
Time Frame
Once in first three days after giving informed consent and another time 7 or 14 days later
Title
Use of drugs promoting sleep (sedative neuroleptics, hypnotics, sedative antidepressant in the time between 18:00-24:00) (nominal variable: yes or no)
Description
Medical charts review for sedative neuroleptics (e.g. Quetiapine, Haloperidol), sedative antidepressives (e.g. Trazodon), hypnotics present (Benzodiazepines, benzodiazepine-like drugs) in the time between 18:00-24:00 (nominal variable: yes or no )
Time Frame
day 1,2 and day 6,7 or 13,14
Title
Medical chart review for discharge domicile after hospitalisation (nursing home, home, other institution, other)
Description
Domicile after hospital discharge
Time Frame
day 7 or 14
Other Pre-specified Outcome Measures:
Title
Application frequency of the nursing (ritual) protocol
Description
Daily protocol of the received and of the refused interventions of the nursing ritual (frequency)
Time Frame
Every day for up to 14 days from date of giving informed consent to hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of dementia of any severity and type
Allocation to geriatric rehabilitation treatment
Exclusion Criteria:
sleep related respiratory or moving related disorders or Parasomnia
delirium
end of life care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Burkhalter, Dr. sc. med.
Organizational Affiliation
Center of Sleep Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Daily Sleep Enhancement for Hospitalized People With Dementia Following a Nursing Protocol
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