Clinical trial NCT05183607: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Deficiency
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: University of Manitoba
First posted: 2022-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Nutritional Literacy
timeFrame: Baseline
measure: Nutritional Literacy
timeFrame: 1 week pre-surgery
measure: Nutritional Literacy
timeFrame: I month post Hospital discharge
Secondary outcomes:
measure: Nutrition Status - MNA
timeFrame: Baseline
measure: Nutrition Status - MNA
timeFrame: 1 week pre-surgery
measure: Nutrition Status - MNA
timeFrame: 1 month post Hospital discharge
measure: Nutrition Status - BMI
timeFrame: Baseline
measure: Nutrition Status - BMI
timeFrame: 1 Week pre-surgery
measure: Nutrition Status - BMI
timeFrame: 1 Month post hospital discharge
measure: Quality of Life - physical function
timeFrame: Baseline
measure: Quality of Life - physical function
timeFrame: 1 week pre-surgery
measure: Quality of Life - physical function
timeFrame: 1 month post hospital discharge
measure: Nutritional behaviour
timeFrame: Baseline
measure: Nutritional behaviour
timeFrame: 1 Week pre-surgery
measure: Nutritional behaviour
timeFrame: 1 month post hospital discharge
measure: Nutrition Status - PA
timeFrame: Baseline
measure: Nutrition Status - PA
timeFrame: 1 week pre-surgery
measure: Nutrition Status - PA
timeFrame: 1 month post hospital discharge
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Rakesh Arora
role: PRINCIPAL_INVESTIGATOR
References: