Périhabilitation nutritionnelle chez les vétérans âgés subissant une chirurgie
Périadaptation nutritionnelle (riche en protéines) chez les vétérans âgés subissant une chirurgie
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27705
- Durham VA Medical Center, Durham, NC
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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Comparateur actif: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
Délai: 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
Délai: 30-day post-surgery follow-up (endpoint)
|
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
Délai: Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery
|
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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Nutritional Risk Screener-2002
Délai: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
|
Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
|
|
Handgrip Strength
Délai: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
|
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
Délai: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
|
Three day food records will be collected. |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
|
|
Patient Generated-Subjective Global Assessment
Délai: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
|
Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status |
baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
|
|
Discharge Location
Délai: endpoint (30 days post-surgery)
|
determine from medical records |
endpoint (30 days post-surgery)
|
|
Length of Stay
Délai: endpoint (30 days post-surgery)
|
determine from medical records |
endpoint (30 days post-surgery)
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Emergency Department Readmission
Délai: 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
Délai: 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
Délai: 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)
|
|
Hospital Readmission
Délai: endpoint (30 days post-surgery)
|
determine from medical records |
endpoint (30 days post-surgery)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kathryn N. Starr, PhD, Durham VA Medical Center, Durham, NC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- E2348-W
- IK2RX002348 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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