Cater With Care Effect Study

Undernutrition Clinical Trial

— CwC  

Official title:

Effectiveness of Cater With Care Products in Reaching Recommendations for Protein Intake During and After Hospital Stay and in Improving Functional Status After Hospital Stay in Elderly Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213393
• Other study ID #: NL48893.081.14
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: November 11, 2015
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The objective is 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 body weight/day and in improving functional status after hospital stay in elderly patients.

Description:

Rationale: 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.

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.

Study population: Patients of 65 years or over who are admitted to the departments of Geriatrics, Pulmonary Disease, or Internal Medicine of Hospital Gelderse Vallei.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Hospital phase:

• admitted to the wards of Geriatric medicine, Pulmonary Medicine, or Internal Medicine in Hospital Gelderse Vallei

• 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 the study

• consent to continue treatment and study participation after hospital discharge

Exclusion Criteria:

• Hospital phase:

• 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 judgement of a dietician and/or medical staff

• expected length of hospital stay less than 4 days

• renal insufficiency (eGFR < 30 ml/min)

• starting with tube feeding or total parenteral nutrition within 2 days of admission

• refeeding syndrome score > 0 based on hospital screening tool for refeeding risk

• delirium at admission

• receiving palliative care

• Home phase:

• going to a nursing home, rehabilitation centre or hospice after hospital discharge

• cognitive impairment or diagnosed with dementia

• legally incapacitated

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

Dietary Supplement:
• Protein enriched products
The intervention group receives CwC protein enriched products. After discharge the intervention group receives CwC products delivered at home for 12 weeks.
• Usual menu
The control group receives the usual menu, which is energy and protein rich in this elderly patient group. After discharge the control group receives regular products, no protein enrichment, at home for 12 weeks.

Locations

Country	Name	City	State
Netherlands	Hospital Gelderse Vallei	Ede	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BMI	BMI is calculated from weight and length measurements at baseline (0), 2, 6, 12, 24 weeks after hospital discharge.	6 months	No
Other	Physical Activity	Physical Activity will be assessed by using the LAPAQ questionnaire.	6 months	No
Other	Length of hospital stay	The length of hospital stay will be recorded to include in an economic evaluation.	12 weeks	No
Other	Costs of hospital stay	After discharge from the hospital, the costs of hospital stay will be calculated to include in the economic evaluation.	12 weeks	No
Primary	Change from Baseline Protein intake and Physical functioning at 6 months	This study has 2 primary outcomes: protein intake and physical functioning. These will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.	6 months	No
Secondary	Change in muscle strength from baseline to 6 months.	Muscle strength (leg and hand grip) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.	6 months	No
Secondary	Change in nutritional status from baseline to 6 months.	Nutritional status (MNA and dietary intake) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.	6 months	No
Secondary	Change in Quality of Life from baseline to 6 months.	Quality of Life will be assessed with the EuroQoL-5D-5L (at baseline, and 12 and 24 weeks after hospital discharge)	6 months.	No
Secondary	Change in Activities of Daily Living from baseline to 6 months.	Activities of Daily Living (ADL) will be assessed by using the Barthel index (at baseline, and 2, 6, 12 and 24 weeks after hospital discharge).	6 months	No