Perihabilitação Nutricional em Idosos Veteranos Submetidos a Cirurgia
Perihabilitação Nutricional (Alta em Proteínas) em Idosos Veteranos Submetidos a Cirurgia
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Durham VA Medical Center, Durham, NC
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Nutritional Risk Screener-2002
Prazo: 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)
|
|
Handgrip Strength
Prazo: 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
Prazo: 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)
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|
Patient Generated-Subjective Global Assessment
Prazo: 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)
|
|
Discharge Location
Prazo: endpoint (30 days post-surgery)
|
determine from medical records |
endpoint (30 days post-surgery)
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|
Length of Stay
Prazo: 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
Prazo: endpoint (30 days post-surgery)
|
Prevalence of emergency department admissions following surgery. |
endpoint (30 days post-surgery)
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Postoperative Complications
Prazo: endpoint (30 days post-surgery)
|
determine from medical records |
endpoint (30 days post-surgery)
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Albumin, g/dL
Prazo: 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
Prazo: endpoint (30 days post-surgery)
|
determine from medical records |
endpoint (30 days post-surgery)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kathryn N. Starr, PhD, Durham VA Medical Center, Durham, NC
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- E2348-W
- IK2RX002348 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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Informações sobre medicamentos e dispositivos, documentos de estudo
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