Nutritional Status in Hospitalised Geriatric PatientsNCT02490761
Food Intake in Older Patients
An observational study of Nutritional Status in Hospitalised Geriatric Patients, run by NHS Greater Glasgow and Clyde.
Trial summary
Unintentional weight loss and undernutrition are well described problems in elderly inpatients, occurring in around 23% to 62% of hospitalised elderly in developed countries. Not only are a large number of elderly patients undernourished at admission but a substantial proportion will lose weight and become… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nutritional Status in Hospitalised Geriatric Patients
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2015to 3 Aug 2016
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted to the geriatric wards at the South Glasgow University Hospital, Glasgow or the Royal Alexandra Hospital, Paisley.
Who may be able to join
- Screened for study participation within 96 hours after admission
- Duration of hospital admission expected to be more than 3 days
- Able to provide consent or consent obtainable from their legal representative
Who cannot join
- Receiving palliative care
About this study
Official title: Food Intake and Preferences in Older Patients During Hospitalisation
Unintentional weight loss and undernutrition are well described problems in elderly inpatients, occurring in around 23% to 62% of hospitalised elderly in developed countries. Not only are a large number of elderly patients undernourished at admission but a substantial proportion will lose weight and become malnourished during their hospital stay, putting them at increased risk of morbidity, mortality, poor clinical outcomes and prolonged length of hospital stay. However, as it is frequently impossible to correct undernutrition prior to hospital admission, every effort should be made to prevent weight loss and correct undernutrition during hospitalization. Therefore, screening and identification of predictors of patients at risk of weight loss and undernutrition at admission, and identification of modifiable factors (e.g. eating preferences and poor food hospital intake), where intervention might be helpful, are important aspects in the management of these patients.
Before designing a food intervention study, there is a need to, firstly:
Read more
- describe hospital food intake, eating habits and preferences in elderly inpatients during hospitalization
- describe predictors of hospital food intake in elderly during hospitalisation
- compare energy and protein intake in elderly inpatients during hospitalisation with the United Kingdom Dietary Reference Values (DRVs)
This study is a hospital based observational study. Eligible participants will be 125 patients (aged ≥ 65 years old) admitted to the geriatric wards of 2 hospitals in the West of Scotland. Eligible participants will be seen 96 hours after admission in order to explain the study process and to obtain written consent. The researcher will record basic body size measurements and will ask the patient questions about living conditions, feelings, memory, health, eating habits, opinions about the hospital food service. Nursing staff will be asked about patient's functional activity. The researcher will also take pictures of a subset of patients' main meals (breakfast, lunch and dinner) on a single day, prior to and after eating. The researcher will meet each patient three times in total. The first time 4 days after admission; a second time, during the hospital stay and, finally, around the time of discharge to repeat some measurements including weight, BMI, skinfold, mid upper arm circumference, grip strength and calf circumference.
- Keywords
- Geriatrics, Nutritional Status, Hospitalisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Patients aged 65 years or over admitted to a geriatric ward in 2 hospitals for more than 3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital food intake
Percentage of served hospital food portion consumed
Measured: Hospital admission to discharge - median 15-20 days
Secondary outcomes (5)
Predictor of hospital food intake in elderly patients
Risk of malnutrition as measured by Mini Nutritional Assessment Short Form (MNASF)
Measured: Hospital admission to discharge - median 15-20 days
Predictor of hospital food intake in elderly patients
Functionality as measured by Barthel index of activities of daily living questionnaire
Measured: Hospital admission to discharge - median 15-20 days
Predictor of hospital food intake in elderly patients
Mental status as measured by Mini Mental State Examination (MMSE)
Measured: Hospital admission to discharge - median 15-20 days
Predictor of hospital food intake in elderly patients
Quality of Life as measured by "EQ-5D" questionnaire
Measured: Hospital admission to discharge - median 15-20 days
Eating habits
As measured by Simplified Nutritional Appetite Questionnaire (SNAQ)
Measured: Hospital admission to discharge - median 15-20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study start22 Sep 2015
- Primary completion3 Aug 2016
- Study completion3 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Status in Hospitalised Geriatric PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Konstantinos Gerasimidis, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490761
- Sponsor's protocol ID
- GN15HN293
- Status last verified
- Aug 2017
- First submitted
- 2 Jul 2015
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Intake and Preferences in Older Patients During Hospitalisation
- ClinicalTrials.gov ID
- NCT02490761
- Acronym / sponsor ID
- GN15HN293
- Keywords
- Geriatrics, Nutritional Status, Hospitalisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 22 Sep 2015 (actual)
- Primary completion
- 3 Aug 2016 (actual)
- Study completion
- 3 Aug 2016 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unintentional weight loss and undernutrition are well described problems in elderly inpatients, occurring in around 23% to 62% of hospitalised elderly in developed countries. Not only are a large number of elderly patients undernourished at admission but a substantial proportion will lose weight and become malnourished during their hospital stay, putting them at increased risk of morbidity, mortality, poor clinical outcomes and prolonged length of hospital stay. However, as it is frequently impossible to correct undernutrition prior to hospital admission, every effort should be made to prevent weight loss and correct undernutrition during hospitalization. Therefore, screening and identification of predictors of patients at risk of weight loss and undernutrition at admission, and identification of modifiable factors (e.g. eating preferences and poor food hospital intake), where intervention might be helpful, are important aspects in the management of these patients.
Before designing a food intervention study, there is a need to, firstly:
- describe hospital food intake, eating habits and preferences in elderly inpatients during hospitalization
- describe predictors of hospital food intake in elderly during hospitalisation
- compare energy and protein intake in elderly inpatients during hospitalisation with the United Kingdom Dietary Reference Values (DRVs)
This study is a hospital based observational study. Eligible participants will be 125 patients (aged ≥ 65 years old) admitted to the geriatric wards of 2 hospitals in the West of Scotland. Eligible participants will be seen 96 hours after admission in order to explain the study process and to obtain written consent. The researcher will record basic body size measurements and will ask the patient questions about living conditions, feelings, memory, health, eating habits, opinions about the hospital food service. Nursing staff will be asked about patient's functional activity. The researcher will also take pictures of a subset of patients' main meals (breakfast, lunch and dinner) on a single day, prior to and after eating. The researcher will meet each patient three times in total. The first time 4 days after admission; a second time, during the hospital stay and, finally, around the time of discharge to repeat some measurements including weight, BMI, skinfold, mid upper arm circumference, grip strength and calf circumference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | –Patients aged 65 years or over admitted to a geriatric ward in 2 hospitals for more than 3 days |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to the geriatric wards at the South Glasgow University Hospital, Glasgow or the Royal Alexandra Hospital, Paisley.
Key inclusion criteria (3 listed)
- Screened for study participation within 96 hours after admission
- Duration of hospital admission expected to be more than 3 days
- Able to provide consent or consent obtainable from their legal representative
Key exclusion criteria (1 listed)
- Receiving palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital food intake
Time frame: Hospital admission to discharge - median 15-20 days
Percentage of served hospital food portion consumed
5 secondary outcomes
Predictor of hospital food intake in elderly patients
Time frame: Hospital admission to discharge - median 15-20 days
Predictor of hospital food intake in elderly patients
Time frame: Hospital admission to discharge - median 15-20 days
Predictor of hospital food intake in elderly patients
Time frame: Hospital admission to discharge - median 15-20 days
Predictor of hospital food intake in elderly patients
Time frame: Hospital admission to discharge - median 15-20 days
Eating habits
Time frame: Hospital admission to discharge - median 15-20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Gerasimidis, PhD principal investigator
University of Glasgow
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Status in Hospitalised Geriatric Patients, run by NHS Greater Glasgow and Clyde.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital food intake (time frame: Hospital admission to discharge - median 15-20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2017.