Daily Sleep Enhancement for Hospitalized People With Dementia Following a Nursing Protocol

Dementia Clinical Trial

Official title:

Daily Sleep Enhancement for Hospitalized People With Dementia Following a 7 Step Nursing Protocol: a Quasi-experimental Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953574
• Other study ID #: 2016-00780
• Status: Completed
• Phase: N/A
• First received: October 20, 2016
• Last updated: August 7, 2017
• Start date: September 2016
• Est. completion date: August 3, 2017

Study information

• Verified date: August 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 3, 2017
• Est. primary completion date: August 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Sleep

Intervention

Procedure:
• daily sleep enhancement nursing protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Application frequency of the nursing (ritual) protocol	Daily protocol of the received and of the refused interventions of the nursing ritual (frequency)	Every day for up to 14 days from date of giving informed consent to hospital discharge
Primary	Bedtime in minutes	Protocol of daily bedtime	Daily for up to 14 days from date of giving informed consent to hospital discharge
Secondary	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	Every second day for up to 14 days from date of giving informed consent to hospital discharge
Secondary	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	Every second day for up to 14 days from date of giving informed consent to hospital discharge
Secondary	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	Once in first three days after giving informed consent and another time 7 or 14 days later
Secondary	Physical performance measured with the Handgrip strength test	Handgrip strength in Pascal	Once in first three days after giving informed consent and another time 7 or 14 days later
Secondary	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 )	day 1,2 and day 6,7 or 13,14
Secondary	Medical chart review for discharge domicile after hospitalisation (nursing home, home, other institution, other)	Domicile after hospital discharge	day 7 or 14