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

August 7, 2017 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: daily sleep enhancement nursing protocol

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)
Procedure: daily sleep enhancement nursing protocol
No Intervention: usual nursing care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bedtime in minutes
Time Frame: Daily for up to 14 days from date of giving informed consent to hospital discharge
Protocol of daily bedtime
Daily for up to 14 days from date of giving informed consent to hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. severe compromised
  2. substantial compromised
  3. moderate compromised
  4. mild compromised
  5. not compromised
Every second day for up to 14 days from date of giving informed consent to hospital discharge
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:

  1. severe
  2. substantial
  3. moderate
  4. mild
  5. none
Every second day for up to 14 days from date of giving informed consent to hospital discharge
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
Once in first three days after giving informed consent and another time 7 or 14 days later
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
Once in first three days after giving informed consent and another time 7 or 14 days later
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 )
day 1,2 and day 6,7 or 13,14
Medical chart review for discharge domicile after hospitalisation (nursing home, home, other institution, other)
Time Frame: day 7 or 14
Domicile after hospital discharge
day 7 or 14

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Every day for up to 14 days from date of giving informed consent to hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Hanna Burkhalter, Dr. sc. med., Center of Sleep Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

August 3, 2017

Study Completion (Actual)

August 3, 2017

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-00780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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