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

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

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.

Study Overview

• Status: Completed
• Conditions: Nutritional Deficiency
• Intervention / Treatment: Other: Virtual Nutrition Education

Detailed Description

The proposed VIP study will utilize an interventional feasibility design to implement and evaluate the impact of a virtual nutrition intervention prehab program on cardiac surgery patients. The VIP study looks to measure patient adherence and acceptability, and practicality of the remote platform in hopes it will illicit change to the current standard of nutrition care being provided to cardiac surgery patients.

The current standards of care do not call for dietitian involvement for cardiac surgery patients' pre-surgery and little to no involvement for patients not receiving CABG surgery. This feasibility study looks to address this gap in current patient nutrition care.

The study intervention will provide eligible patients (n=20) with access to four 25-30 minute virtual sessions with a registered dietitian during the two-week period prior to surgery. The dietitian will provide the patient with nutrition counseling prior to the patient's elective cardiac surgery. Zoom (or equivalent) software will be utilized as a remote platform to connect the dietitian virtually with participants during all sessions. The four sessions will follow the same presentation format and will provide all participants with identical nutrition education with curriculum content progressing in each subsequent session. Each session will be comprised of protein education and goal setting, with education content building on previous sessions with a goal of improving patient protein intake perioperatively.

Data will be collected on: (1) participant demographics, (2) physical function, (3) nutritional status and (4) nutrition literacy.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual nutritional Intervention; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition Status - MNA	participant nutritional status - Mini nutritional assessment	Baseline
Nutrition Status - MNA	participant nutritional status - Mini nutritional assessment	1 week pre-surgery
Nutrition Status - MNA	participant nutritional status - Mini nutritional assessment	1 month post Hospital discharge
Nutrition Status - BMI	participant nutritional status - Body Mass Index (BMI)	Baseline
Nutrition Status - BMI	participant nutritional status - Body Mass Index (BMI)	1 Week pre-surgery
Nutrition Status - BMI	participant nutritional status - Body Mass Index (BMI)	1 Month post hospital discharge
Quality of Life - physical function	modified Short Form - 36 questionnaire to measure physical function	Baseline
Quality of Life - physical function	modified Short Form - 36 questionnaire to measure physical function	1 week pre-surgery
Quality of Life - physical function	modified Short Form - 36 questionnaire to measure physical function	1 month post hospital discharge
Nutritional behaviour	3-Day Food Record	Baseline
Nutritional behaviour	3-Day Food Record	1 Week pre-surgery
Nutritional behaviour	3-Day Food Record	1 month post hospital discharge
Nutrition Status - PA	participant nutritional status - pre-albumin	Baseline
Nutrition Status - PA	participant nutritional status - pre-albumin	1 week pre-surgery
Nutrition Status - PA	participant nutritional status - pre-albumin	1 month post hospital discharge

Collaborators and Investigators

• Sponsor: St. Boniface Hospital
• Collaborators: University of Manitoba
• Investigators: Principal Investigator: Rakesh Arora, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2022
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: HS25164 (H2021:336)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No