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Completed

NCT Number: NCT02953574

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

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.

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Key information

Conditions

Sleep Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

daily sleep enhancement nursing protocol

Procedure

Primary outcomes

  1. Bedtime in minutes

    Time frame: Daily for up to 14 days from date of giving informed consent to hospital discharge

    Protocol of daily bedtime

Secondary outcomes

  1. Sleeps through the night consistently, 5 point ordinal scale from "severe compromised" to "not compromised"

    Time frame: Every second day for up to 14 days from date of giving informed consent to hospital discharge

    Subitem of the Outcome 'Sleep' from the Nursing Outcome Classification (NOC)

    Scale:

    • severe compromised
    • substantial compromised
    • moderate compromised
    • mild compromised
    • not compromised

  2. Inappropriate napping, 5 point ordinal scale ranging from "sever" to "none"

    Time frame: Every second day for up to 14 days from date of giving informed consent to hospital discharge

    Subitem of the Outcome 'Sleep' from the Nursing Outcome Classification (NOC)

    Scale:

    • severe
    • substantial
    • moderate
    • mild
    • none

  3. Cognitive performance (Mini-mental-status-test score)

    Time frame: Once in first three days after giving informed consent and another time 7 or 14 days later

    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

  4. Physical performance measured with the Handgrip strength test

    Time frame: Once in first three days after giving informed consent and another time 7 or 14 days later

    Handgrip strength in Pascal

  5. Use of drugs promoting sleep (sedative neuroleptics, hypnotics, sedative antidepressant 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

    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 )

  6. Medical chart review for discharge domicile after hospitalisation (nursing home, home, other institution, other)

    Time frame: day 7 or 14

    Domicile after hospital discharge

Other outcomes

  1. Application frequency of the nursing (ritual) protocol

    Time frame: Every day for up to 14 days from date of giving informed consent to hospital discharge

    Daily protocol of the received and of the refused interventions of the nursing ritual (frequency)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2016
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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