手術を受ける高齢の退役軍人における栄養周病
手術を受ける高齢の退役軍人における栄養（高タンパク）周辺リハビリテーション
This research study will be conducted in two parts. The first part will consist of selecting appropriate screening and assessment tools for Veterans undergoing elective surgery and identifying the number of Veterans who are malnourished and at risk of malnutrition. The second portion of the study will be to determine if a protein-enhanced diet before and after surgery will improve function and postoperative outcomes and compare the results to an education control group.
調査の概要
状態
詳細な説明
In year 1 of the two-part research study, an observational, prospective study of 75 Veterans preparing for elective surgery will be conducted. The purpose of this study will be to select appropriate nutrition screening and assessment tools and to employ them to characterize malnutrition prevalence and severity and establish cut-off values associated with malnutrition in this population. In years 2-5 of the research two-part research study, a pilot randomized controlled trial will be conducted. The purpose of this study will be evaluate the feasibility, fidelity, and acceptability of a perioperative protein-enhanced intervention compared to an educational control. Veterans who are malnourished or at risk of being malnourished will be randomly assigned on a 1:1 ratio to either an education (nutritional counseling) control or high-protein perihabilitation arm. Participants in the high-protein perihabilitation arm will be provided with 30 grams of high quality protein supplements three times per day. The study will take place two weeks prior to an elective abdominal or GI surgery and will continue 4 weeks post surgery.
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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North Carolina
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Durham、North Carolina、アメリカ、27705
- Durham VA Medical Center, Durham, NC
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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:
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Elective abdominal surgery
- upper GI
- colorectal
- hepatobiliary
- pancreatic
- intra-abdominal
- Abdominal aortic aneurysm
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Referred to the VA Perioperative Optimization of Senior Health Clinic
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Able to record dietary intake or has a proxy who can record dietary intake
Exclusion Criteria:
- Cognitive impairment
- Unwillingness to be randomized to either intervention arm, submit to study testing, or continuously participate in the intervention for six weeks
- Living in skilled nursing facility
- No access to telephone
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：ヘルスサービス研究
- 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：PeriHab
Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery. |
Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery.
他の名前：
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アクティブコンパレータ：PoshControl
Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery. |
provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
他の名前：
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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 |
|---|---|---|
|
Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
時間枠：day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
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Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained. |
day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
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Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control
時間枠：30-day post-surgery follow-up (endpoint)
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Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree |
30-day post-surgery follow-up (endpoint)
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Physical Function
時間枠：Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery
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Short physical performance battery - higher scores means a better physical performance (Total score = 0-12) |
Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Nutritional Risk Screener-2002
時間枠：baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Handgrip Strength
時間枠：baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Hand dynamometer will be used to determine grip strength. Maximum grip strength will be determined by conducting two trials on the dominant hand, with 30 second rest between trials. |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Dietary Intake
時間枠：baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Three day food records will be collected. |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Patient Generated-Subjective Global Assessment
時間枠：baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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Discharge Location
時間枠：endpoint (30 days post-surgery)
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determine from medical records |
endpoint (30 days post-surgery)
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Length of Stay
時間枠：endpoint (30 days post-surgery)
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determine from medical records |
endpoint (30 days post-surgery)
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Emergency Department Readmission
時間枠：endpoint (30 days post-surgery)
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Prevalence of emergency department admissions following surgery. |
endpoint (30 days post-surgery)
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Postoperative Complications
時間枠：endpoint (30 days post-surgery)
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determine from medical records |
endpoint (30 days post-surgery)
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Albumin, g/dL
時間枠：baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
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A measure of protein in the blood. Lower level may indicate infection or inflammation. |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
|
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Hospital Readmission
時間枠：endpoint (30 days post-surgery)
|
determine from medical records |
endpoint (30 days post-surgery)
|
協力者と研究者
捜査官
- 主任研究者：Kathryn N. Starr, PhD、Durham VA Medical Center, Durham, NC
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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。