Cater With Care Effect Study (CwC)
Effectiveness of Cater With Care Products in Reaching Recommendations for Protein Intake During and After Hospital Stay and in Improving Functional Status After Hospital Stay in Elderly Patients.
調査の概要
詳細な説明
Rationale: About 25% of hospitalized elderly patients are at risk of undernutrition at admission. Many hospitals provide an energy and protein enriched diet, extra snacks, and oral nutritional supplements if needed. Still, a considerable part of these patients are unable to meet protein requirements and are still at risk of undernutrition at hospital discharge. This may impair recovery of illness, partly due to loss of muscle mass and physical performance. To improve protein intake, Cater with Care products have been developed: a selection of foods and drinks that are consumed often by elderly persons, but now enriched with protein up to 10 grams per portion. We hypothesize that these products help to reach protein requirements in elderly patients during and after hospital stay and thereby improve their health outcomes.
Objective: To study the effectiveness of supplementing a standard hospital and 12-week home menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5 g/kg/day and in improving functional status after hospital stay in elderly patients.
Study design: Randomised Controlled Trial (RCT) with 2 intervention groups and two phases: a hospital phase including all admitted patients and a home phase with a selection of patients.
Study population: Patients of 65 years or over who are admitted to the departments of Geriatrics, Pulmonary Disease, or Internal Medicine of Hospital Gelderse Vallei.
Intervention: The control group receives the standard hospital menu for elderly at risk of undernutrition (energy and protein rich) and a variety of foods and drinks to be used as part of their home diet for 12 weeks after hospitalization. Foods and drinks for home use are non-enriched variants of Cater with Care products (e.g. normal fruit juice).
The intervention group receives Cater with Care protein-enriched foods and drinks during hospital stay (in addition to the standard hospital menu) and at home as part of their home diet for 12 weeks.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Gelderland
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Ede、Gelderland、オランダ、6716 RP
- Hospital Gelderse Vallei
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参加基準
適格基準
就学可能な年齢
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:
- Hospital phase:
- admitted to the wards of Geriatric medicine, Pulmonary Medicine, or Internal Medicine in Hospital Gelderse Vallei
- aged 65 years or over
- being eligible for receiving a standard protein enriched menu based on hospital protocol
- Home phase:
- included in the hospital phase of the study
- consent to continue treatment and study participation after hospital discharge
Exclusion Criteria:
- Hospital phase:
- unwilling to give consent for gathering data from the medical record or meal service system
- unable to understand Dutch
- food allergies, food intolerances or other dietary restrictions that prevents the patient from receiving the standard protein enriched menu or Cater with Care products based on the judgement of a dietician and/or medical staff
- expected length of hospital stay less than 4 days
- renal insufficiency (eGFR < 30 ml/min)
- starting with tube feeding or total parenteral nutrition within 2 days of admission
- refeeding syndrome score > 0 based on hospital screening tool for refeeding risk
- delirium at admission
- receiving palliative care
- Home phase:
- going to a nursing home, rehabilitation centre or hospice after hospital discharge
- cognitive impairment or diagnosed with dementia
- legally incapacitated
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：処理
- 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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実験的：Protein enriched products
The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.
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The intervention group receives CwC protein enriched products.
After discharge the intervention group receives CwC products delivered at home for 12 weeks.
他の名前：
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アクティブコンパレータ：Usual menu
The control group receives the usual protein and energy rich menu in the hospital and receives regular products, no protein enrichment, after discharge during 12 weeks.
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The control group receives the usual menu, which is energy and protein rich in this elderly patient group.
After discharge the control group receives regular products, no protein enrichment, at home for 12 weeks.
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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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Change from Baseline Protein intake and Physical functioning at 6 months
時間枠：6 months
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This study has 2 primary outcomes: protein intake and physical functioning.
These will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
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6 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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Change in muscle strength from baseline to 6 months.
時間枠：6 months
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Muscle strength (leg and hand grip) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
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6 months
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Change in nutritional status from baseline to 6 months.
時間枠：6 months
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Nutritional status (MNA and dietary intake) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
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6 months
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Change in Quality of Life from baseline to 6 months.
時間枠：6 months.
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Quality of Life will be assessed with the EuroQoL-5D-5L (at baseline, and 12 and 24 weeks after hospital discharge)
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6 months.
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Change in Activities of Daily Living from baseline to 6 months.
時間枠：6 months
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Activities of Daily Living (ADL) will be assessed by using the Barthel index (at baseline, and 2, 6, 12 and 24 weeks after hospital discharge).
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6 months
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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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BMI
時間枠：6 months
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BMI is calculated from weight and length measurements at baseline (0), 2, 6, 12, 24 weeks after hospital discharge.
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6 months
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Physical Activity
時間枠：6 months
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Physical Activity will be assessed by using the LAPAQ questionnaire.
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6 months
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Length of hospital stay
時間枠：12 weeks
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The length of hospital stay will be recorded to include in an economic evaluation.
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12 weeks
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Costs of hospital stay
時間枠：12 weeks
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After discharge from the hospital, the costs of hospital stay will be calculated to include in the economic evaluation.
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12 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Nicole M de Roos, PhD、Wageningen University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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
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。
Protein enriched productsの臨床試験
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