Self-care Program in the Prevention of Admissions of Patients (AUTOCUID)
Effectiveness of an Self-care Program in the Prevention of Admissions of Patients With Hospitalizations Potentially Avoidable: Randomized Clinical Trial
One of the most cost effective intervention is to avoid unnecessary hospitalizations in the national health system. These unnecessary admissions are increasing for several years, reaching rates of over 30% in patients with chronic obstructive pulmonary disease (COPD) or heart failure at two months of hospital discharge. There is scientific evidence suggesting that a multidisciplinary intervention consisting in controling disease and stress associated with disease, and modifying eating habits could reduce the number of hospitalizations due to disease decompensation.
The main objective of the study is to assess the rate of readmissions at year of multidisciplinary intervention in patients with COPD and / or heart failure.
We will select 144 patients who will be randomized to two groups (control and intervention group) and they will be followed for 12 months through 4 visits (1 month, 3 months, 6 months and 12 months of hospital discharge).
Patients assigned to the intervention group will be receive three educational sessions (one of them will be imparted by nursing, another by the nutritionist and the last one by the psychologist). In addition, patients with a BMI <20 and / or> 30 will receive a closer monitoring by the nutritionist).
Patients assigned to the control group will receive usual care in clinical practice.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Alava
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Vitoria-Gasteiz、Alava、スペイン、01009
- 募集
- Araba Universitary Hospital (Txagorritxu)
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コンタクト：
- Naiara Parraza, PhD
- 電話番号：945007413
- メール：naiara.parrazadiez@osakidetza.net
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- COPD
- Heart failure: heart failure in clinically stable with ≥ II degree of NYHA . 1 or more emergency admissions for the same diagnosis in the prior year
Exclusion Criteria:
- Mental states that make difficult the self-care: Class 295, 296, 297, 298, 300, 301, 304 and 316 (schizophrenic disorders, episodic mood, delusional other nonorganic psychosis, anxiety, dissociative and somatoform, personality, alcohol and drug dependencies)
- Congenital respiratory diseases or presence of other obstructive pulmonary diseases
- Patients participating in other research studies.
- Other diseases that can affect patients' medium-term survival
- Moderate to severe cognitive impairment.
研究計画
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：防止
- 割り当て：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 |
|---|---|
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介入なし：Control group
Habitual Clinical Practice
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実験的：Intervention Group
Multidisciplinary intervention consisting in controlling disease and stress associated to it, and modifying eating habits.
A Nurse, nutritionist and a psychologist will be the responsible of these educational sessions.
it will be three educational sessions.
Patients with a BMI lower than 20 or bigger than 30 will be receive a closer follow up by nutritionist.
In addition, patients with a score of 9 or more in the Patients Health Questionnaire-9 questionnaire will be also a closer follow up with the psychologist.
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Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits
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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 |
|---|---|---|
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Readmission rate
時間枠：12 months
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in the twelve months following the intervention, according to the electronic record of the hospital
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12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service
時間枠：12 months
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12 months
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time until the first admission to the hospital
時間枠：it wil be measured at 12 months
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it wil be measured at 12 months
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time until first visit to general practitioner's office
時間枠：it will be measured at 12 months
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it will be measured at 12 months
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time until the first visit to emergency service
時間枠：it will be measured at 12 months
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it will be measured at 12 months
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Health related quality of life through several questionnaires
時間枠：At month, 3, 6 and 12 months after discharge
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COPD Assessment Test (CAT), self efficacy scale in COPD patients, SORT Form-36, Patient Health Questionnaire-9, Minnesota Living with Heart Failure Questionnaire (MLHFQ), Physical Activity Questionnaire (IPAQ), Barthel Index, European heart failure self-care behaviour scale.
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At month, 3, 6 and 12 months after discharge
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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HbA1c
時間枠：at month, 3, 6 and 12 months
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glycated hemoglobin
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at month, 3, 6 and 12 months
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Type B natriuretic peptide (BNP), blood pressure
時間枠：At month, 3, 6 and 12 months of discharge
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At month, 3, 6 and 12 months of discharge
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APACHE III INDEX, Functional Category of New York Heart Association (NYHA)
時間枠：1 day
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1 day
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AC-01
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