A Logical Framework for Tailor-made Paradigm Shift Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals
Primary Purpose
Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, Malnutrition
Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
MY GERYFS PROTOCOL
Sponsored by
About this trial
This is an interventional prevention trial for Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, Malnutrition
Eligibility Criteria
Inclusion Criteria:
- Patients aged 60 years and older
- Able to understand and speak Malay or English or both
- Patients who are on oral diet or on Oral Nutrition Support (ONS) or both
- Patients who are admitted for more than 48 hours
Exclusion Criteria:
- Patients who are mentally disturbed
- Critically ill patients
- Patients who are on full enteral or parenteral feeding
Sites / Locations
- Hospital SelayangRecruiting
- Hospital Tengku Ampuan Rahimah KlangRecruiting
- Hospital Pengajar Universiti Putra Malaysia
- Hospital Sungai BulohRecruiting
- Hospital Kuala lumpurRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
CONTROL
INTERVENTION
Arm Description
without MY GERYFS
with MY GERYFS
Outcomes
Primary Outcome Measures
Nutritional Status
Malnutrition assessment of the elderly will be done using Mini Nutritional Assessment-Short Form (MNA-SF). This 7-item questionnaire includes dimensions from food intake, weight status, mobility status, presence of psychological problems and neurological stress level. The total score is categorised into three which are normal nutritional status (12-14 points), at risk of malnutrition (8-11 points) and malnourished (0-7 points).
Secondary Outcome Measures
Medical Background
Medical background of the patients will be obtained through patients' medical records and interviewing method. The medical history of the patients includes reasons of admission, date of admission, date of discharge, days of hospitalisation, types and numbers of comorbidities, numbers of drugs prescription, previous hospitalisation and whether the patient has encountered a dietitian visit during hospitalisation. All of these data will be recorded in the self-developed questionnaire.
Anthropometry Measurements
Anthropometry measurements of the patients include current and previous body weight, percentage of body weight change, height, body mass index (BMI), mid upper arm circumference (MUAC), calf circumference, triceps skin fold (TSF) and body fat percentage. The body weight of hospitalised patients will be measured using Digital Weighing Scale OMRON HBF-357 and recorded in kilogram (kg) to the nearest 0.1 kg Weight estimation is done to geriatric patients who are unable to stand without assistance or non-ambulatory. The outcome measured will be in Body Mass Index (kg/The Body Mass Index classification will be used as stated in WHO (2004) which is underweight (<18.5kg/m1), normal weight (18.5 to 24.9kg/m2), overweight (25.0 to 29.9kg/m2) and obesity (>30.0kg/m2).
Hand Grip Strength
The hand-grip strength test used Jamar Plus+Digital Handgrip Dynamometer as tools of assessment to evaluate muscle strength. The cut-off point recommended for the hadgrip strength is < 26kg/force (men) and <18kg/force (women) consider low strength. While, > 26kg/force (men) and >18kg/force (women) consider normal strength.
Feeding Assistance
The respondents' level of feeding assistance will be acquired directly from the patients or caregivers via interviewing method using self-developed questionnaire. The researchers are required to assess the respondents' feeding assistance level during main meals. The level of feeding assistance is classified into four. The level of feeding assistance is classified into dependent, moderate dependent (≥5 minutes), minimal dependent (<5 minutes), and independent.
Visual Ability
The respondents' information on visual ability will be acquired via self- reported. The researchers are required to observe if the respondents wear glasses during mealtimes.
Dental Status
The dental status will be assessed using Geriatric Oral Health Assessement Index (GOHAI) instrument) 12 questions were developed to evaluate three dimensions of oral health-related quality of life (QoL). These include physical function during eating, psychosocial function including worry or concern about oral health, dissatisfaction with appearance, self-consciousness about oral health an avoidance of social contacts because of oral problems and pain or discomfort including the use of medication to relieve pain or discomfort from the mouth. Each question is given a score 1 to 5. A higher GOHAI score (≥57) indicates better self-reported oral health status and high perception towards oral health, 51 and 56 (average), 12 - 50 (low perception) towards oral health.
Dietary Intake
Dietary intake will be obtained by using 24-hour dietary recall for 2 days in the hospital. The dietary intake will be taken among patients who are admitted for ≥ 48 hours and have taken at least two hospital meals. The estimated amount of food will then be converted into grams and later finalised into subject's total energy, macronutrients (protein, carbohydrates and fat) , micronutrients (fat-soluble vitamins, water-soluble vitamins, potassium, sodium, calcium, phosphate, zinc and iron) as well as fibre. The respondents' energy and protein requirements will be estimated above 70% energy and 80% protein consider adequate. This will be done by Nutritionist Pro software.
Mealtime Barriers
Mealtime Audit Tool (MAT) instrument is used to measure the respondents' mealtime barriers/issues. This instrument consists of two distinct parts which are Part 1: observation of the time of meal tray arrival (completed by the researcher) and Part 2: list of key challenges or barriers individual patients may experience (completed by the patients). MAT scoring is based on the total of 'NO' responses. The higher the score, the more barriers experienced by the patient.
Hospital Foodservice Satisfaction
The Acute Care Hospital Foodservice Patient Satisfaction (ACHFPSQ) questionnaire will be used. Other than that, the statements were grouped into four main dimensions (food quality, meal service quality, staff/service issues, and physical environment) to know the factor scores of the dimensions. The questionnaire uses a 5-point Likert scale (Always = 5, Often = 4, Sometimes = 3, Rarely = 2, and Never =1). This grouping was to measure the highest and lowest score factors affecting satisfaction with hospital foodservice. The relationship between foodservice dimensions with overall satisfaction was assessed with Multiple Linear Regression Analysis. Statements that were worded negatively were scored using the reverse scoring method. The higher the mean score, the better the results were.
Full Information
NCT ID
NCT04858165
First Posted
March 30, 2021
Last Updated
June 23, 2021
Sponsor
Universiti Putra Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT04858165
Brief Title
A Logical Framework for Tailor-made Paradigm Shift Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals
Official Title
A Logical Framework for Tailor-made Paradigm Shift Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia
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
Hospital Food service is important for patient recovery by providing necessary aid with adequate meal consumption. Overall, hospital experience can influence patients' satisfaction for the foodservice quality. Thus, it is important to evaluate patient satisfaction with food service to meet consumers' needs in order to prevent malnutrition. The aim of the studies is to develop the Malaysian geriatric patients' hospital foodservice protocol (My GERYFS). There are 3 Phases in this research which is phase 1 is a multicentre cohort study conducted among elderly and healthcare professionals involved in Klang Valley Hospitals. Phase 2 for To develop a tailor-made hospital foodservice protocol for Malaysian geriatric patients with healthcare professional input and phase 3 is to determine the feasibility and cost-effectiveness of MY GERYFS protocol in a Malaysian hospital. Effectiveness of this study protocol can bring benefits to elderly to prevent malnutrition in the hospitals via foodservice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, Malnutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
without MY GERYFS
Arm Title
INTERVENTION
Arm Type
Other
Arm Description
with MY GERYFS
Intervention Type
Procedure
Intervention Name(s)
MY GERYFS PROTOCOL
Intervention Description
The MY GERYFS will be introduced through a guideline document, dissemination through the department of nursing, notices on the intranet and provision of large signs indicating that MY GERYFS are in progress and the times of meals for each ward. The developed protocol in phase 1 and 2 will be tested in single-centre in a before and after study for its feasibility and safety. In the pre-study, patients will be given usual care. In the post-study, patients will care according to the developed protocol. Clinical outcomes such as malnutrition risk, medical background, anthropometry data, nutrition-focused physical findings, dietary intake, mealtime barrier, Hospital Foodservices satisfaction will be recorded.
Primary Outcome Measure Information:
Title
Nutritional Status
Description
Malnutrition assessment of the elderly will be done using Mini Nutritional Assessment-Short Form (MNA-SF). This 7-item questionnaire includes dimensions from food intake, weight status, mobility status, presence of psychological problems and neurological stress level. The total score is categorised into three which are normal nutritional status (12-14 points), at risk of malnutrition (8-11 points) and malnourished (0-7 points).
Time Frame
8 minutes
Secondary Outcome Measure Information:
Title
Medical Background
Description
Medical background of the patients will be obtained through patients' medical records and interviewing method. The medical history of the patients includes reasons of admission, date of admission, date of discharge, days of hospitalisation, types and numbers of comorbidities, numbers of drugs prescription, previous hospitalisation and whether the patient has encountered a dietitian visit during hospitalisation. All of these data will be recorded in the self-developed questionnaire.
Time Frame
5 minutes
Title
Anthropometry Measurements
Description
Anthropometry measurements of the patients include current and previous body weight, percentage of body weight change, height, body mass index (BMI), mid upper arm circumference (MUAC), calf circumference, triceps skin fold (TSF) and body fat percentage. The body weight of hospitalised patients will be measured using Digital Weighing Scale OMRON HBF-357 and recorded in kilogram (kg) to the nearest 0.1 kg Weight estimation is done to geriatric patients who are unable to stand without assistance or non-ambulatory. The outcome measured will be in Body Mass Index (kg/The Body Mass Index classification will be used as stated in WHO (2004) which is underweight (<18.5kg/m1), normal weight (18.5 to 24.9kg/m2), overweight (25.0 to 29.9kg/m2) and obesity (>30.0kg/m2).
Time Frame
8 minutes
Title
Hand Grip Strength
Description
The hand-grip strength test used Jamar Plus+Digital Handgrip Dynamometer as tools of assessment to evaluate muscle strength. The cut-off point recommended for the hadgrip strength is < 26kg/force (men) and <18kg/force (women) consider low strength. While, > 26kg/force (men) and >18kg/force (women) consider normal strength.
Time Frame
2 minutes
Title
Feeding Assistance
Description
The respondents' level of feeding assistance will be acquired directly from the patients or caregivers via interviewing method using self-developed questionnaire. The researchers are required to assess the respondents' feeding assistance level during main meals. The level of feeding assistance is classified into four. The level of feeding assistance is classified into dependent, moderate dependent (≥5 minutes), minimal dependent (<5 minutes), and independent.
Time Frame
30 seconds
Title
Visual Ability
Description
The respondents' information on visual ability will be acquired via self- reported. The researchers are required to observe if the respondents wear glasses during mealtimes.
Time Frame
30 seconds
Title
Dental Status
Description
The dental status will be assessed using Geriatric Oral Health Assessement Index (GOHAI) instrument) 12 questions were developed to evaluate three dimensions of oral health-related quality of life (QoL). These include physical function during eating, psychosocial function including worry or concern about oral health, dissatisfaction with appearance, self-consciousness about oral health an avoidance of social contacts because of oral problems and pain or discomfort including the use of medication to relieve pain or discomfort from the mouth. Each question is given a score 1 to 5. A higher GOHAI score (≥57) indicates better self-reported oral health status and high perception towards oral health, 51 and 56 (average), 12 - 50 (low perception) towards oral health.
Time Frame
2 minutes
Title
Dietary Intake
Description
Dietary intake will be obtained by using 24-hour dietary recall for 2 days in the hospital. The dietary intake will be taken among patients who are admitted for ≥ 48 hours and have taken at least two hospital meals. The estimated amount of food will then be converted into grams and later finalised into subject's total energy, macronutrients (protein, carbohydrates and fat) , micronutrients (fat-soluble vitamins, water-soluble vitamins, potassium, sodium, calcium, phosphate, zinc and iron) as well as fibre. The respondents' energy and protein requirements will be estimated above 70% energy and 80% protein consider adequate. This will be done by Nutritionist Pro software.
Time Frame
10 minutes
Title
Mealtime Barriers
Description
Mealtime Audit Tool (MAT) instrument is used to measure the respondents' mealtime barriers/issues. This instrument consists of two distinct parts which are Part 1: observation of the time of meal tray arrival (completed by the researcher) and Part 2: list of key challenges or barriers individual patients may experience (completed by the patients). MAT scoring is based on the total of 'NO' responses. The higher the score, the more barriers experienced by the patient.
Time Frame
5 minutes
Title
Hospital Foodservice Satisfaction
Description
The Acute Care Hospital Foodservice Patient Satisfaction (ACHFPSQ) questionnaire will be used. Other than that, the statements were grouped into four main dimensions (food quality, meal service quality, staff/service issues, and physical environment) to know the factor scores of the dimensions. The questionnaire uses a 5-point Likert scale (Always = 5, Often = 4, Sometimes = 3, Rarely = 2, and Never =1). This grouping was to measure the highest and lowest score factors affecting satisfaction with hospital foodservice. The relationship between foodservice dimensions with overall satisfaction was assessed with Multiple Linear Regression Analysis. Statements that were worded negatively were scored using the reverse scoring method. The higher the mean score, the better the results were.
Time Frame
5 minutes
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged 60 years and older
Able to understand and speak Malay or English or both
Patients who are on oral diet or on Oral Nutrition Support (ONS) or both
Patients who are admitted for more than 48 hours
Exclusion Criteria:
Patients who are mentally disturbed
Critically ill patients
Patients who are on full enteral or parenteral feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noraida Omar, PhD
Phone
+60192252902
Email
noraidaomar@upm.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Siti Hazimah Norhisham, BSc (Dietetics)
Phone
+60189424625
Email
hazimahshn@gmail.com
Facility Information:
Facility Name
Hospital Selayang
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adlin Natasya Mohd Said, Dietitian
Phone
+60361263333
Email
adlinn@selayanghospitals.gov.my
Facility Name
Hospital Tengku Ampuan Rahimah Klang
City
Klang
State/Province
Selangor
ZIP/Postal Code
41200
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamilah Zakaria, Dietitian
Phone
03-3375 7000
Ext
1053
Email
jamienizam.282@gmail.com
Facility Name
Hospital Pengajar Universiti Putra Malaysia
City
Serdang
State/Province
Selangor
ZIP/Postal Code
43400
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Hospital Sungai Buloh
City
Sungai Buloh
State/Province
Selangor
ZIP/Postal Code
47000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noor Shidah Yussof, Dietitian
Phone
03-61454333
Ext
7104
Email
shidahyussof@gmail.com
First Name & Middle Initial & Last Name & Degree
Noor Shidah Yussof, dietetics
Facility Name
Hospital Kuala lumpur
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Nur Khairunnisa Wan Kozil, Dietitian
Phone
603-26156011
Email
wnknisa12@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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A Logical Framework for Tailor-made Paradigm Shift Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals
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