JBH: Evaluating the Impact of the Eating Matters Program on the Nutritional Status of Elderly Patients at Joseph Brant Hospital

Sponsor
Joseph Brant Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04445883
Collaborator
Compass Group Canada (Other)
80
2
11

Study Details

Study Description

Brief Summary

This research study will determine the impact of the Eating Matters Program on the nutritional status of elderly patients at Joseph Brant Hospital. The Eating Matters Program at Joseph Brant Hospital is a volunteer-based feeding assistance program that aims to improve patients' nutritional intake by providing assistance during mealtimes. As research on the impact of such programs on food intake is limited in Canada, this study will explore how the Eating Matters Program influences protein and energy intake of patients at Joseph Brant Hospital. Further, this study will explore if the hypothesized increase in protein and energy intake with the initiation of the Eating Matters Program is correlated with a decreased risk of malnutrition.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Feeding Assistance
N/A

Detailed Description

We will be conducting a prospective open-label non-randomized controlled trial to evaluate patients' nutritional outcomes in units that have the Eating Matters Program available (Study Group A) vs. similar units that do not have this program (Control Group B), as this can provide useful data on the effectiveness of such programs in developing innovative prevention strategies to address hospital malnutrition.

A total sample size of eighty participants (40 in each group) will be included in this study from Medical and Rehabilitation units at Joseph Brant Hospital. Study group A will include patients from the medical unit on 6S100 in addition to the Rehab units on 6N400/500. Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200. Baseline food intake data (including breakfast, lunch and dinner) will be gathered during a 2-day period for both Study Group A and Control Group B. Following the collection of baseline data, feeding assistance will then be provided to participants in the units that have the EMP program available (6S100 and 6N400/500). In addition, food intake will be recorded for a total of 6 days for both Study Group A, and Control Group B. Outcome measures including C-reactive protein and weight will be measured weekly. Following, a Subjective Global Assessment (SGA) will be completed and Hand Grip Strength will be recorded on days 1 and 18 as the literature shows that this is an appropriate timeframe to reassess these measures (Flood et al., 2014; Canadian Malnutrition Task Force, 2019). Energy and protein intake will then be calculated using visual estimation by completion of the My Meal Intake Tool, and the hospital's CBORD software. Further, to evaluate the success of the feeding assistance program, volunteers will distribute the feedback survey to patients, staff, family members or friends of participants. To prevent contamination from staff working on both sides, members of the research team will have a discussion with staff to explain that the study and potential benefits should not be discussed, as this may impact the research findings.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The investigators will be evaluating patients' nutritional outcomes in units that have the Eating Matters Program available vs. similar units that do not have this program. Therefore, there will be two groups, Study Group A and Control Group B.The investigators will be evaluating patients' nutritional outcomes in units that have the Eating Matters Program available vs. similar units that do not have this program. Therefore, there will be two groups, Study Group A and Control Group B.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluating the Impact of a Volunteer Based Mealtime Assistance Program on the Nutritional Status of Elderly Patients at Joseph Brant Hospital in Ontario, Canada
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group A

Study group A will include patients from the medical unit on 6S100 in addition to the Rehab units on 6N400/500. Participants in Study Group A will be receiving mealtime assistance from volunteers via the Eating Matters Program.

Behavioral: Feeding Assistance
Patients will be receiving assistance during mealtimes. This includes assistance by opening packages, listing/explaining the food products on the tray, providing encouragement and companionship during mealtimes and directly feed patients.

No Intervention: Control Group B

Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200.

Outcome Measures

Primary Outcome Measures

  1. Dietary Intake [To assess a change from baseline to energy and protein intake post program initiation at the one and two week mark (+/-2days).]

    Protein and Energy Intake

Other Outcome Measures

  1. Percent weight change [A change from baseline body weight at 1 week and 2 weeks marks (+/-2) days post the initiation of the Eating Matters Program (EMP).]

    Participants' weight will be measured.

  2. Handgrip strength [A change from baselines in handgrip measure at 1 and 2 weeks marks (+/-2 days) post the initiation of EMP.]

    Handgrip strength measured using hand dynamometers.

  3. C-Reactive Protein [A change from baselines CRP at 1 week and 2 weeks marks (+/-2 days) post the initiation of EMP.]

    C-Reactive Protein will be measured via routine lab work.

  4. Eating Matters Program Feedback [This will be measured on day 19 (+/-2 days) (total study period for each participant).]

    Perceptions of program implementation and Barriers to food intake will be evaluated via feedback forms.

  5. Length of stay [This data will be gathered on day 120 (+/-2days), upon completion of the study.]

    Unit Specific Measure

  6. Mortality rate [This data will be gathered on day 120 (+/- 2days), upon completion of the study.]

    Unit Specific Measure

  7. Re-admission rate [This data will be gathered on day 120 (+/- 2 days), upon completion of the study.]

    Unit Specific Measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients 65 years and over admitted to Medicine and Rehabilitation units at Joseph Brant Hospital with an anticipated stay 10-14 days

  • Patients with a Subjective Global Assessment score of B or C, and identified to require eating assistance

  • Patients able to provide consent or have a Power of Attorney to do so on their behalf

Exclusion Criteria:
  • Patients that are NPO status (nothing by mouth)

  • Patients that require enteral or total parenteral feeding

  • Palliative care patients

  • Severe cognitive impairment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Joseph Brant Hospital
  • Compass Group Canada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Diala Chayab, Clinical Dietitian, Joseph Brant Hospital
ClinicalTrials.gov Identifier:
NCT04445883
Other Study ID Numbers:
  • JosephBrantH
First Posted:
Jun 24, 2020
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 16, 2022