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

NCT ID: NCT05183607

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-28

Study Completion Date

2023-02-28

Brief Summary

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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

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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.

Conditions

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Nutritional Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Virtual Nutrition Education

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role collaborator

St. Boniface Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Rakesh C. Arora

Section Head and Regional Lead - Cardiac Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rakesh Arora

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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HS25164 (H2021:336)

Identifier Type: -

Identifier Source: org_study_id

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