Nutritionele perihabilitatie bij oudere veteranen die een operatie ondergaan
Nutritionele (eiwitrijke) perihabilitatie bij oudere veteranen die een operatie ondergaan
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27705
- Durham VA Medical Center, Durham, NC
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
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Actieve vergelijker: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Nutritional Risk Screener-2002
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
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Discharge Location
Tijdsspanne: endpoint (30 days post-surgery)
|
determine from medical records |
endpoint (30 days post-surgery)
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Length of Stay
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: endpoint (30 days post-surgery)
|
determine from medical records |
endpoint (30 days post-surgery)
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Kathryn N. Starr, PhD, Durham VA Medical Center, Durham, NC
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- E2348-W
- IK2RX002348 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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