A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study Protocol

NCT05183607 | Completed

• 1 other identifier: HS25164 (H2021:336)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study will look to identify the impact that a remote/virtual nutritional intervention can have on nutrition literacy and knowledge retention of the cardiac surgery patient.

Conditions

Nutritional Deficiency

Outcome Measures

Primary Outcomes (3)

• Nutritional Literacy

  measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire

  Baseline

• Nutritional Literacy

  measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire

  1 week pre-surgery

• Nutritional Literacy

  measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire

  I month post Hospital discharge

Secondary Outcomes (15)

• Nutrition Status - MNA

  Baseline

• Nutrition Status - MNA

  1 week pre-surgery

• Nutrition Status - MNA

  1 month post Hospital discharge

• Nutrition Status - BMI

  Baseline

• Nutrition Status - BMI

  1 Week pre-surgery

Study Arms (1)

Virtual nutritional Intervention

EXPERIMENTAL

This arm will receive the virtual nutritional intervention consisting of 4 - 30 minute sessions to educate cardiac surgery patients before their date of surgery. Each session will provide a different theme such as: 1) nutritional assessment, 2) protein intake education, 3) nutritional adequacy prior to surgery, and 4) protein and nutrition intake post surgery

Other: Virtual Nutrition Education

Interventions

Virtual Nutrition Education OTHER

4 interventional sessions will be provided using a virtual communication platform and delivered remotely to each participant by a registered dietitian. The virtual counseling sessions will be led by a registered dietitian and delivered to each participant remotely

Virtual nutritional Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• undergoing non-emergent/elective cardiac surgery

You may not qualify if:

• not able to communicate in English (read or write)
• in-patients (urgent or emergent care)
• patients who self report protein supplementation on a regular basis

Sponsors & Collaborators

• St. Boniface Hospital: lead
• University of Manitoba: collaborator

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Rakesh Arora

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head and Regional Lead - Cardiac Surgery

Model Details: Study sessions will be provided using a virtual communication platform and delivered remotely to each participant by a registered dietitian. The virtual counseling sessions will be led by a registered dietitian and delivered to each participant remotely while in the comfort of their own residence or where it is deemed to be comfortable and safe.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 10, 2022
• Study Start: January 28, 2022
• Primary Completion: December 23, 2022
• Study Completion: February 28, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)