Malnutrition Clinical Trial
Official title:
Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery
Verified date | January 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Elective abdominal surgery - upper GI - colorectal - hepatobiliary - pancreatic - intra-abdominal - Abdominal aortic aneurysm - Referred to the VA Perioperative Optimization of Senior Health Clinic - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Durham VA Medical Center, Durham, NC | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. | 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) | |
Primary | Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control | 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) | |
Primary | Physical Function | 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 | |
Secondary | Hospital Readmission | determine from medical records | endpoint (30 days post-surgery) | |
Secondary | Dietary Intake | Three day food records will be collected. | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | |
Secondary | Handgrip Strength | 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) | |
Secondary | Nutritional Risk Screener-2002 | Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | |
Secondary | Patient Generated-Subjective Global Assessment | Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status | baseline, day of surgery (midpoint), 30-day post-surgery (endpoint) | |
Secondary | Discharge Location | determine from medical records | endpoint (30 days post-surgery) | |
Secondary | Length of Stay | determine from medical records | endpoint (30 days post-surgery) | |
Secondary | Emergency Department Readmission | Prevalence of emergency department admissions following surgery. | endpoint (30 days post-surgery) | |
Secondary | Postoperative Complications | determine from medical records | endpoint (30 days post-surgery) | |
Secondary | Albumin, g/dL | 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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