Undernutrition Clinical Trial
— CwCOfficial 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.
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Hospital Gelderse Vallei | Ede | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Wageningen University |
Netherlands,
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 |
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