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Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia (I-care)

24. marts 2015 opdateret af: Jeong Jee Hyang, Ewha Womans University Mokdong Hospital

A Multicenter, Randomized Trial to Assess Efficacy of Therapeutic Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia

The purpose of this study is to investigate if behavioral intervention for dementia caregivers will decrease caregiver burden in caregivers of patients with dementia. This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS).

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The intervention program includes not only the knowledge of dementia and how to manage behavioral problems of patients with dementia but also individual psychological counselling about caregiver's distress. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS). Secondary outcomes are changes in scores of neuropsychiatric inventory and Korean -instrumental Activities of Daily Living of patients as well as depression scores of caregivers.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

80

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

30 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 30-80years old
  • Caregivers who spend their own time with dementia patients over 4 hours a day
  • caregiver distress scores >= 2
  • caregivers of patients in Alzheimer's disease dementia ( mild to moderate stage of dementia, Mini-Mental Status Examination:10~26)

Exclusion Criteria:

  • illiterate
  • severe hearing/visual acuity difficulty
  • cognitive impairment

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
Basic information about dementia
Aktiv komparator: Behavioral intervention

Individual, 90 min a day, with an interval of 2 weeks

  • Education about dementia
  • psychological counselling
  • cognitive behavioral therapy
Adfærdsmæssigt: Behavioral intervention
  • What the dementia is
  • How to deal with behavioral problems in patients with dementia
  • How to manage caregiver's stress
  • How to care dementic patients as well as caregivers themselves

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Caregiver burden (Zaret's Burden Inventory (ZBI)
Tidsramme: baseline/10-12 week (after intervention)
Zaret's Burden Inventory (ZBI)
baseline/10-12 week (after intervention)
Changes in quality of life of caregivers as assessed by Philadelphia Geriatric Center for Moral Scale (PGCMS)
Tidsramme: baseline/10-12 week (after intervention)
Philadelphia Geriatric Center for Moral Scale (PGCMS)
baseline/10-12 week (after intervention)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in behavioral problems of patients with dementia as assessed by the Neuropsychiatry inventory
Tidsramme: baseline/10-12 week (after intervention)
Neuropsychiatry inventory
baseline/10-12 week (after intervention)
Changes in Depression of caregivers as assessed by the geriatric depression scale
Tidsramme: baseline/10-12 week (after intervention)
Geriatric depression scale
baseline/10-12 week (after intervention)

Samarbejdspartnere og efterforskere

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

Sponsor

Ewha Womans University Mokdong Hospital

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. marts 2015

Primær færdiggørelse (Forventet)

1. december 2015

Studieafslutning (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

13. marts 2015

Først indsendt, der opfyldte QC-kriterier

24. marts 2015

Først opslået (Skøn)

25. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EUMC2014-12-028

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 Behavioral intervention

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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