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

7. august 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

70 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Ingen indgriben: usual nursing care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bedtime in minutes
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleeps through the night consistently, 5 point ordinal scale from "severe compromised" to "not compromised"
Tidsramme: 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"
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: day 7 or 14
Domicile after hospital discharge
day 7 or 14

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Application frequency of the nursing (ritual) protocol
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Zurich

Efterforskere

  • Ledende efterforsker: Hanna Burkhalter, Dr. sc. med., Center of Sleep Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2016

Primær færdiggørelse (Faktiske)

3. august 2017

Studieafslutning (Faktiske)

3. august 2017

Datoer for studieregistrering

Først indsendt

20. oktober 2016

Først indsendt, der opfyldte QC-kriterier

31. oktober 2016

Først opslået (Skøn)

3. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2016-00780

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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