Effects and Costs of a Day Care Centre Program Designed for People With Dementia (ECOD)
7 février 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
261
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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-
-
Tønsberg, Norvège, 3103
- Norwegian centre of Ageing and Health
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Day care for patients with dementia
|
Day care centres designed by the local authorities for patients with dementia
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|
Aucune intervention: Prendre soin comme d'habitude
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Admittance to nursing home care
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Quality of life for patients
Délai: 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
Délai: 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
Délai: 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
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12 and 24 months
|
|
Change in patient's cognition
Délai: 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
Délai: 12 and 24 months
|
The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
|
12 and 24 months
|
|
Patients death
Délai: 24 months
|
Number of patients that have died during 24 months will be registered
|
24 months
|
|
Change in level of burden in family carers
Délai: 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
Délai: 12 and 24 months
|
The MADRS will be used to assess depressive symptoms in family carers
|
12 and 24 months
|
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Change in quality of life for family carers
Délai: 12 and 24 months
|
QoL-AD will be used to assess quality of life in family carers
|
12 and 24 months
|
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Differences in the use of health resources between the intervention group and the control group
Délai: 12 and 24 months
|
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
Délai: 12 and 24 months
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A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years
|
12 and 24 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Knut Engedal, Professor, Norwegian Centre for Ageling and health
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 août 2013
Achèvement primaire (Réel)
1 décembre 2017
Achèvement de l'étude (Réel)
31 décembre 2017
Dates d'inscription aux études
Première soumission
11 septembre 2013
Première soumission répondant aux critères de contrôle qualité
11 septembre 2013
Première publication (Estimation)
16 septembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 février 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 février 2020
Dernière vérification
1 février 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NCAH-ECOD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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