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

Nutritional Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05183607
• Other study ID #: HS25164 (H2021:336)
• Status: Completed
• Phase: N/A
• Start date: January 28, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2023
• Source: St. Boniface Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2023
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Nutritional Deficiency

Intervention

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

Locations

Country	Name	City	State
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
St. Boniface Hospital	University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional Literacy	measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire	Baseline
Primary	Nutritional Literacy	measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire	1 week pre-surgery
Primary	Nutritional Literacy	measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire	I month post Hospital discharge
Secondary	Nutrition Status - MNA	participant nutritional status - Mini nutritional assessment	Baseline
Secondary	Nutrition Status - MNA	participant nutritional status - Mini nutritional assessment	1 week pre-surgery
Secondary	Nutrition Status - MNA	participant nutritional status - Mini nutritional assessment	1 month post Hospital discharge
Secondary	Nutrition Status - BMI	participant nutritional status - Body Mass Index (BMI)	Baseline
Secondary	Nutrition Status - BMI	participant nutritional status - Body Mass Index (BMI)	1 Week pre-surgery
Secondary	Nutrition Status - BMI	participant nutritional status - Body Mass Index (BMI)	1 Month post hospital discharge
Secondary	Quality of Life - physical function	modified Short Form - 36 questionnaire to measure physical function	Baseline
Secondary	Quality of Life - physical function	modified Short Form - 36 questionnaire to measure physical function	1 week pre-surgery
Secondary	Quality of Life - physical function	modified Short Form - 36 questionnaire to measure physical function	1 month post hospital discharge
Secondary	Nutritional behaviour	3-Day Food Record	Baseline
Secondary	Nutritional behaviour	3-Day Food Record	1 Week pre-surgery
Secondary	Nutritional behaviour	3-Day Food Record	1 month post hospital discharge
Secondary	Nutrition Status - PA	participant nutritional status - pre-albumin	Baseline
Secondary	Nutrition Status - PA	participant nutritional status - pre-albumin	1 week pre-surgery
Secondary	Nutrition Status - PA	participant nutritional status - pre-albumin	1 month post hospital discharge