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Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, MalnutritionNCT04858165

A Logical Framework for Tailor-made Paradigm Shift Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals

A study testing MY GERYFS PROTOCOL in people with Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, Malnutrition, run by Universiti Putra Malaysia at 5 sites in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
MY GERYFS PROTOCOL
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
5 sitesMalaysia
Study dates
1 Sep 2020to 30 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patients who are mentally disturbed
  • Critically ill patients
  • Patients who are on full enteral or parenteral feeding

Trial locations and contacts

5 sites in 1 country.

Noraida Omar, PhD contact

+60192252902

noraidaomar@upm.edu.my

Siti Hazimah Norhisham, BSc (Dietetics) contact

+60189424625

hazimahshn@gmail.com

5 sites in 1 country

Malaysia5 sites, 5 recruiting
  • Hospital Selayang

    Batu Caves, Selangor, 68100

    Adlin Natasya Mohd Said, Dietitian, +60361263333, adlinn@selayanghospitals.gov.my

    Recruiting
  • Hospital Tengku Ampuan Rahimah Klang

    Klang, Selangor, 41200

    Jamilah Zakaria, Dietitian, 03-3375 7000 ext. 1053, jamienizam.282@gmail.com

    Recruiting
  • Hospital Kuala lumpur

    Kuala Lumpur, Kuala Lumpur, 50586

    Wan Nur Khairunnisa Wan Kozil, Dietitian, 603-26156011, wnknisa12@gmail.com

    Recruiting
  • Hospital Pengajar Universiti Putra Malaysia

    Serdang, Selangor, 43400

    Not yet recruiting
  • Hospital Sungai Buloh

    Sungai Buloh, Selangor, 47000

    Noor Shidah Yussof, Dietitian, 03-61454333 ext. 7104, shidahyussof@gmail.com

    Noor Shidah Yussof, dietetics

    Recruiting

Other trials in Malaysia

About this study

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.

Being tested
MY GERYFS PROTOCOL
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MY GERYFS PROTOCOLProcedure or surgery

    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.

Study groups in NCT04858165
Study groupRoleWhat they receive
CONTROLNo interventionwithout MY GERYFS
INTERVENTIONOtherwith MY GERYFS
Receives: Procedure: MY GERYFS PROTOCOL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 8 minutes

Secondary outcomes (9)
  1. 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.

    Measured: 5 minutes

  2. 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).

    Measured: 8 minutes

  3. 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.

    Measured: 2 minutes

  4. 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.

    Measured: 30 seconds

  5. 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.

    Measured: 30 seconds

  6. 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.

    Measured: 2 minutes

  7. 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.

    Measured: 10 minutes

  8. 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.

    Measured: 5 minutes

  9. 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.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2021
  2. Study start1 Sep 2020
  3. Primary completion30 Nov 2022 (estimated)
  4. Study completion30 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04858165
Sponsor's protocol ID
283284-331068
Status last verified
Jun 2021
First submitted
30 Mar 2021
Last updated
29 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Omar N, Shafiee SI, Nor'hisham SH, Ibrahim Z, Jamaluddin R, Rahamat S, Mohd Yusof BN, Minhat HS, Sallehuddin H, Mazlan NS. A Logical Framework (MYGERYFS) for Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals, Malaysia: Protocol for a Feasibility Study. JMIR Res Protoc. 2023 Jan 31;12:e42496. doi: 10.2196/42496.

    PubMed 36719732

Questions about this trial

What is this clinical trial studying?

A study testing MY GERYFS PROTOCOL in people with Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, Malnutrition, run by Universiti Putra Malaysia at 5 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Noraida Omar, PhD (+60192252902, noraidaomar@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutritional Status (time frame: 8 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04858165, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.

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