Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effects and Costs of a Day Care Centre Program Designed for People With Dementia (ECOD)

7. februar 2020 opdateret af: Norwegian Centre for Ageing and Health

Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study

Attending day care centres with programs specifically designed for patients with dementia is believed to postpone admittance to nursing home as well as increase quality of life and well-being for both patients and their family caregivers. We aim to investigate to what degree attendance in day care centres with programs for people with dementia is effective for patient and their caregivers whilst also cost efficient for society. The study consists of a quasi-experimental trial with comparison group. 400 patients with dementia, along with a family caregiver, will be included in the trial. Effects will be measured at baseline, after one and two years. Data collection will be made at three levels; at patient level with measures of cognition, depression, quality of life, functioning in activities in daily living, neuropsychiatric symptoms and death; at caregiver level with measures of depression, level of burden and quality of life; and at societal level with measures of nursing home admittance, hospital stays and use of other health resources. Additionally,a qualitative interview study will include 20 dyads from the main trial. The main focus will be on how attending day care centre programs for patients with dementia affect the lives of both patients and caregivers. Five of these dyads will be followed closely throughout the participation period to be used as case examples.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A quasi experimental trial with a comparison group will be performed to evaluate the effect of the day care centre programs by comparing results from municipalities with (intervention group) and without (comparison group) a day care centre program designed for people with dementia using standardized assessment tools. Furthermore, a survey will be used to explore the communication and co-operation between the professional staff at the day care centre, the patients and the family carers by administering questionnaires to all three parties. Only patients with mild degree of dementia will be asked to participate in the questionnaire. Finally, qualitative interviews will be made with 20 dyads of patients and family carers to collect their in depth experience with the day care centre program. Five of these patients and their family carers will be followed closely as case examples for two years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

261

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Norge
      • Tønsberg, Norge, 3103
        • Norwegian centre of Ageing and Health

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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age of 65 years or more and living at home
  • Patients in the day care centre group must have attended the centre for at least four weeks and have been there no longer than nine months
  • Dementia of either Alzheimer's type, vascular dementia, dementia with Lewy bodies/Parkinson's disease or a mixture of these types of dementias
  • Capacity to give informed consent as judged by the professional caregivers
  • A Mini Mental Status Examination (MMSE) score of ≥15
  • Having a family carer willing to participate, who see the patients personally at least once a week
  • Attending the day care centre program at least twice a week

Exclusion Criteria:

  • Having applied for nursing home placement
  • Suffering from a serious co-morbid physical disorder with life expectancy less than six months

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Day care for patients with dementia
Adfærdsmæssigt: Day care for patients with dementia
Day care centres designed by the local authorities for patients with dementia
Ingen indgriben: Pas på som sædvanlig

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Admittance to nursing home care
Tidsramme: 24 months
The number of patients admitted to nursing home care during a period of 24 months will be the primary outcome for the effect and the cost-consequence analysis
24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Quality of life for patients
Tidsramme: 12 and 24 months
The quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)
12 and 24 months
Change in the patient's functioning of daily living
Tidsramme: 12 and 24 months
The Physical self-Maintenance Scale and Instrumental Activities of Daily Living Scale will be used to assess change in the patient's function of daily living
12 and 24 months
Change in depressive symptoms in patients
Tidsramme: 12 and 24 months
The change in depressive symptoms will be assessed by Montgomery Asberg Depression Rating Scale (MADRS)by interviews with both patient and family carer and the Cornell Scale for Depression in Dementia (CSDD) by interviews with family carers and a professional caregiver
12 and 24 months
Change in patient's cognition
Tidsramme: 12 and 24 months
Patient's cognition will be assessed using the Mini Mental State Examination (MMSE) the Clock Drawing Test (CDT), the Trail Making Test A (TMT-A)and the 10 word test of the Consortium to Establish a Registry in Alzheimer's Disease (CERAD)
12 and 24 months
Change in neuropsychiatric symptoms in patients
Tidsramme: 12 and 24 months
The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
12 and 24 months
Patients death
Tidsramme: 24 months
Number of patients that have died during 24 months will be registered
24 months
Change in level of burden in family carers
Tidsramme: 12 and 24 months
Level of burden for family carers will be assessed by using the Relative's Stress Scale (RSS)
12 and 24 months
Change in family carers depressive symptoms
Tidsramme: 12 and 24 months
The MADRS will be used to assess depressive symptoms in family carers
12 and 24 months
Change in quality of life for family carers
Tidsramme: 12 and 24 months
QoL-AD will be used to assess quality of life in family carers
12 and 24 months
Differences in the use of health resources between the intervention group and the control group
Tidsramme: 12 and 24 months
The use of health resources will be measured using the resource Utilization in Dementia scale (RUD)
12 and 24 months
Differences in quality adjusted life years between the intervention group and the control group
Tidsramme: 12 and 24 months
A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years
12 and 24 months

Samarbejdspartnere og efterforskere

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

Sponsor

Norwegian Centre for Ageing and Health

Samarbejdspartnere

The Research Council of Norway

Efterforskere

  • Studiestol: Knut Engedal, Professor, Norwegian Centre for Ageling and health

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.

Generelle publikationer

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 (Faktiske)

1. august 2013

Primær færdiggørelse (Faktiske)

1. december 2017

Studieafslutning (Faktiske)

31. december 2017

Datoer for studieregistrering

Først indsendt

11. september 2013

Først indsendt, der opfyldte QC-kriterier

11. september 2013

Først opslået (Skøn)

16. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCAH-ECOD

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 .

Kliniske forsøg med Demens

Kliniske forsøg med Day care for patients with dementia

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Serbia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner