Effects and Costs of a Day Care Centre Program Designed for People With Dementia (ECOD)
2020年2月7日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
261
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Tønsberg、ノルウェー、3103
- Norwegian centre of Ageing and Health
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年歳以上 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Day care for patients with dementia
|
Day care centres designed by the local authorities for patients with dementia
|
|
介入なし：いつものケア
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Admittance to nursing home care
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Quality of life for patients
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：12 and 24 months
|
The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
|
12 and 24 months
|
|
Patients death
時間枠：24 months
|
Number of patients that have died during 24 months will be registered
|
24 months
|
|
Change in level of burden in family carers
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：12 and 24 months
|
A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years
|
12 and 24 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Knut Engedal, Professor、Norwegian Centre for Ageling and health
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年8月1日
一次修了 (実際)
2017年12月1日
研究の完了 (実際)
2017年12月31日
試験登録日
最初に提出
2013年9月11日
QC基準を満たした最初の提出物
2013年9月11日
最初の投稿 (見積もり)
2013年9月16日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月10日
QC基準を満たした最後の更新が送信されました
2020年2月7日
最終確認日
2020年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。