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Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation

6. april 2015 opdateret af: US Department of Veterans Affairs
This project is a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people undergoing post-acute rehabilitation.

Studieoversigt

Detaljeret beskrivelse

The purpose of this study is to perform a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people (N = 214) undergoing post-acute rehabilitation. The intervention will combine: 1) structured sleep assessment, 2) patient education in key elements of cognitive behavioral strategies to improve sleep, and 3) environmental interventions on factors which likely contribute to abnormal sleep/wake patterns in the post-acute rehabilitation setting.

This project will be conducted in a VA post-acute rehabilitation site. Older veterans (>= 60 years) who were previously community-dwelling (N = 214) will be randomized to receive the intervention, or a social contact and memory skills training program as the control condition. Data collected at baseline will include medical data and demographics, as well as subjective and objective measures of sleep, structured assessments of functional status, and medical comorbidity. Follow-up assessments will be performed in the facility while the intervention/control condition is in place, and at three months and six months after discharge from rehabilitation. The main outcome measures will include objective sleep measures (nighttime percent sleep and daytime percent sleep) and functional status collected at three and six months follow-up. Data will be analyzed for all randomized participants in an intention to treat analysis.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

219

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • Sepulveda, California, Forenede Stater, 91343
        • VA Greater Los Angeles Healthcare System, Sepulveda, CA

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

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adults aged > or = 60, who are admitted to inpatient rehabilitation services, who lived in a non-institutional setting prior to admission, and are admitted for rehabilitation

Exclusion Criteria:

  • severe sleep apnea
  • severe cognitive impairment
  • not enrolled within one week of admission to rehabilitation unit
  • too ill to participate
  • and planned discharge to a nursing home for total nursing 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: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Nonpharmacological sleep intervention
The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies
Aktiv komparator: Active control
Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pittsburgh Sleep Quality Index
Tidsramme: 3-month follow-up
The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 - 21; score > 8 indicates poor sleep quality).
3-month follow-up
Sleep Efficiency
Tidsramme: 3-month follow-up
Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed.
3-month follow-up

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Cathy A. Alessi, MD, VA Greater Los Angeles Healthcare System, Sepulveda, CA

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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. januar 2007

Primær færdiggørelse (Faktiske)

1. december 2010

Studieafslutning (Faktiske)

1. december 2010

Datoer for studieregistrering

Først indsendt

2. juni 2006

Først indsendt, der opfyldte QC-kriterier

2. juni 2006

Først opslået (Skøn)

6. juni 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. april 2015

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

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 .

Kliniske forsøg med Søvnforstyrrelser

Kliniske forsøg med Nonpharmacological sleep intervention

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