Effects and Costs of a Day Care Centre Program Designed for People With Dementia (ECOD)
7 februari 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
261
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Tønsberg, Norge, 3103
- Norwegian centre of Ageing and Health
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
65 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Day care for patients with dementia
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Day care centres designed by the local authorities for patients with dementia
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Inget ingripande: Vårda som vanligt
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Admittance to nursing home care
Tidsram: 24 months
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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
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24 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Quality of life for patients
Tidsram: 12 and 24 months
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The quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)
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12 and 24 months
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Change in the patient's functioning of daily living
Tidsram: 12 and 24 months
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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
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12 and 24 months
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Change in depressive symptoms in patients
Tidsram: 12 and 24 months
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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
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12 and 24 months
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Change in patient's cognition
Tidsram: 12 and 24 months
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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)
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12 and 24 months
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Change in neuropsychiatric symptoms in patients
Tidsram: 12 and 24 months
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The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
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12 and 24 months
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Patients death
Tidsram: 24 months
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Number of patients that have died during 24 months will be registered
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24 months
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Change in level of burden in family carers
Tidsram: 12 and 24 months
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Level of burden for family carers will be assessed by using the Relative's Stress Scale (RSS)
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12 and 24 months
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Change in family carers depressive symptoms
Tidsram: 12 and 24 months
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The MADRS will be used to assess depressive symptoms in family carers
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12 and 24 months
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Change in quality of life for family carers
Tidsram: 12 and 24 months
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QoL-AD will be used to assess quality of life in family carers
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12 and 24 months
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Differences in the use of health resources between the intervention group and the control group
Tidsram: 12 and 24 months
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The use of health resources will be measured using the resource Utilization in Dementia scale (RUD)
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12 and 24 months
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Differences in quality adjusted life years between the intervention group and the control group
Tidsram: 12 and 24 months
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A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years
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12 and 24 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studiestol: Knut Engedal, Professor, Norwegian Centre for Ageling and health
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 augusti 2013
Primärt slutförande (Faktisk)
1 december 2017
Avslutad studie (Faktisk)
31 december 2017
Studieregistreringsdatum
Först inskickad
11 september 2013
Först inskickad som uppfyllde QC-kriterierna
11 september 2013
Första postat (Uppskatta)
16 september 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 februari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 februari 2020
Senast verifierad
1 februari 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCAH-ECOD
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