To study the effectiveness of supplementing a standard hospital and 12-week home menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5 g/kg/day and in improving functional status after hospital stay in elderly…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen specifieke aandoeningen (voedingsstatus en veroudering)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are:
- Protein intake in grams of protein per kilogram bodyweight on the 4th day of
hospitalization.
- Change of physical performance assessed by the Short Physical Performance
Battery (SPPB) after 12 weeks following hospital discharge.
Secondary outcome
Phase 1 (hospital):
- All foods and drinks served to the patient through the hospital service
system *At Your Request® (AYR). This will be collected daily.
- Protein intake in g/kg/d at the day before discharge.
- Percentage of patients who meet recommended protein intake at Day 4 of
hospitalization.
- Length of hospital stay: in days.
- SPPB at the day before discharge.
- Knee extensor strength at the day before discharge
- Hand grip strength at the day before discharge:
Phase 2 (home):
- Nutritional Status assessed with the Mini Nutritional Assessment (MNA):
- Hand grip strength (hand dynamometer).
- Knee extensor strength (hand-held dynamometer).
- Dietary intake at 2, 6, 12, and 24 weeks after discharge
- Physical Activity will be measured using the LASA Physical Activity
Questionnaire (LAPAQ).
- Activities of Daily Living (ADL) using the Barthel Index
- Quality of life will be measured using the EuroQol-5D-5L questionnaire
- Amount of unplanned readmissions: this will be asked to the participant
during home visits.
Background summary
About 25% of hospitalized elderly patients are at risk of undernutrition at
admission. Many hospitals provide an energy and protein enriched diet, extra
snacks, and oral nutritional supplements if needed. Still, a considerable part
of these patients are unable to meet protein requirements and are still at risk
of undernutrition at hospital discharge. This may impair recovery of illness,
partly due to loss of muscle mass and physical performance. To improve protein
intake, Cater with Care products have been developed: a selection of foods and
drinks that are consumed often by elderly persons, but now enriched with
protein up to 10 grams per portion. We hypothesize that these products help to
reach protein requirements in elderly patients during and after hospital stay
and thereby improve their health outcomes.
Study objective
To study the effectiveness of supplementing a standard hospital and 12-week
home menu with protein-enriched Cater with Care products in reaching a protein
intake of 1,2-1,5 g/kg/day and in improving functional status after hospital
stay in elderly patients.
Study design
Randomised Controlled Trial (RCT) with 2 intervention groups and two phases: a
hospital phase including all admitted patients and a home phase with a
selection of patients.
Intervention
The control group receives the standard hospital menu for elderly at risk of
undernutrition (energy and protein rich) and a variety of foods and drinks to
be used as part of their home diet for 12 weeks after hospitalization. Foods
and drinks for home use are non-enriched variants of Cater with Care products
(e.g. normal fruit juice).
The intervention group receives Cater with Care protein-enriched foods and
drinks during hospital stay (in addition to the standard hospital menu) and at
home as part of their home diet for 12 weeks.
Study burden and risks
The burden of this study is minimal. All patients will receive menus that are
designed to prevent and treat undernutrition taking individual dietary
restrictions into account. The SPPB and other measurements are not invasive.
Blood collection is done in the hospital as part of the routine blood
assessment that is done for every patient admitted to the hospital. If the CwC
menu is more effective in reaching protein requirements than standard menus to
prevent undernutrition, these products could be used in other hospitals, care
homes and at home.
Bomenweg 4
Wageningen 6703HD
NL
Bomenweg 4
Wageningen 6703HD
NL
Listed location countries
Age
Inclusion criteria
Hospital phase (only observational):
- admitted to the wards of Geriatric medicine, Pulmonary Medicine or Internal Medicine in ZGV;
- aged 65 years or over;
- being eligible for receiving a standard protein enriched menu based on hospital protocol;;Home phase:
- included in the hospital phase of this study
- consent to continue treatment and study participation after hospital discharge
Exclusion criteria
- unwilling to give consent for gathering data from the medical record or meal service
system;
- unable to understand Dutch;
- food allergies, food intolerances, or other dietary restrictions that prevents the patient from receiving the standard protein enriched menu or Cater with Care products based on the judgment of a dietician and/or medical staff;
- expected length of hospital stay < 4 days;
- renal insufficiency (eGFR <30);
- starting with tube feeding or total parenteral nutrition within 2 days of admission;
- refeeding syndrome score > 0 based on ZGV screening tool for refeeding risk;
- delirium at admission;
- receiving palliative care;For continuation in the home phase, the following exclusion criteria are formulated:
- going to a nursing home, rehabiliation centre or hospice after hospital discharge;
- cognitive impairment or diagnosed with dementia;
- legally incapacitated
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48893.081.14 |