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

Primary Purpose

Nutritional Deficiency

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Nutrition Education
Sponsored by
St. Boniface Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutritional Deficiency

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Boniface General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual nutritional Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Nutritional Literacy
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
Nutritional Literacy
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
Nutritional Literacy
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire

Secondary Outcome Measures

Nutrition Status - MNA
participant nutritional status - Mini nutritional assessment
Nutrition Status - MNA
participant nutritional status - Mini nutritional assessment
Nutrition Status - MNA
participant nutritional status - Mini nutritional assessment
Nutrition Status - BMI
participant nutritional status - Body Mass Index (BMI)
Nutrition Status - BMI
participant nutritional status - Body Mass Index (BMI)
Nutrition Status - BMI
participant nutritional status - Body Mass Index (BMI)
Quality of Life - physical function
modified Short Form - 36 questionnaire to measure physical function
Quality of Life - physical function
modified Short Form - 36 questionnaire to measure physical function
Quality of Life - physical function
modified Short Form - 36 questionnaire to measure physical function
Nutritional behaviour
3-Day Food Record
Nutritional behaviour
3-Day Food Record
Nutritional behaviour
3-Day Food Record
Nutrition Status - PA
participant nutritional status - pre-albumin
Nutrition Status - PA
participant nutritional status - pre-albumin
Nutrition Status - PA
participant nutritional status - pre-albumin

Full Information

First Posted
December 22, 2021
Last Updated
April 10, 2023
Sponsor
St. Boniface Hospital
Collaborators
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT05183607
Brief Title
A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study Protocol
Official Title
A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 28, 2022 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Boniface Hospital
Collaborators
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual nutritional Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Virtual Nutrition Education
Intervention Description
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
Primary Outcome Measure Information:
Title
Nutritional Literacy
Description
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
Time Frame
Baseline
Title
Nutritional Literacy
Description
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
Time Frame
1 week pre-surgery
Title
Nutritional Literacy
Description
measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire
Time Frame
I month post Hospital discharge
Secondary Outcome Measure Information:
Title
Nutrition Status - MNA
Description
participant nutritional status - Mini nutritional assessment
Time Frame
Baseline
Title
Nutrition Status - MNA
Description
participant nutritional status - Mini nutritional assessment
Time Frame
1 week pre-surgery
Title
Nutrition Status - MNA
Description
participant nutritional status - Mini nutritional assessment
Time Frame
1 month post Hospital discharge
Title
Nutrition Status - BMI
Description
participant nutritional status - Body Mass Index (BMI)
Time Frame
Baseline
Title
Nutrition Status - BMI
Description
participant nutritional status - Body Mass Index (BMI)
Time Frame
1 Week pre-surgery
Title
Nutrition Status - BMI
Description
participant nutritional status - Body Mass Index (BMI)
Time Frame
1 Month post hospital discharge
Title
Quality of Life - physical function
Description
modified Short Form - 36 questionnaire to measure physical function
Time Frame
Baseline
Title
Quality of Life - physical function
Description
modified Short Form - 36 questionnaire to measure physical function
Time Frame
1 week pre-surgery
Title
Quality of Life - physical function
Description
modified Short Form - 36 questionnaire to measure physical function
Time Frame
1 month post hospital discharge
Title
Nutritional behaviour
Description
3-Day Food Record
Time Frame
Baseline
Title
Nutritional behaviour
Description
3-Day Food Record
Time Frame
1 Week pre-surgery
Title
Nutritional behaviour
Description
3-Day Food Record
Time Frame
1 month post hospital discharge
Title
Nutrition Status - PA
Description
participant nutritional status - pre-albumin
Time Frame
Baseline
Title
Nutrition Status - PA
Description
participant nutritional status - pre-albumin
Time Frame
1 week pre-surgery
Title
Nutrition Status - PA
Description
participant nutritional status - pre-albumin
Time Frame
1 month post hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Arora
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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