Dysphagia and malnutrition
Conditions
Interventions
The control group receives standard nutritional and dysphagia management and will be compared to residents in the treatment arm who will receive standard treatment plus the provision of the pre-thicke
Sponsors
Maastricht University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. male or female resident = 65 years of age 2. diagnosis of malnutrition (risk) based on the validated short nutritional assessment questionnaire for residential care (SNAQ-RC) 3. diagnosis of dysphagia based on the 90 mL water swallow test (WST) according to Dutch guidelines and subsequent assessment by the SLT 4. admitted to – or living in a somatic - or psychogeriatric ward in one of the participating nursing homes 5. written IC from participant or legal representative
Exclusion criteria
Exclusion criteria: 1. consequent daily use of protein- and energy containing ONS in the past 4 weeks 2. consequent use of enteral - or parenteral nutrition at the moment of screening or 4 weeks prior to screening 3. renal disease requiring dialysis 4. residents of which both lower legs were amputated 5. investigator’s uncertainty about the willingness or ability of the subject to comply with the protocol requirements 6. known allergy or intolerance to any ingredient of the intervention product, e.g. lactose intolerance or galactosemia 7. participation in any other study involving investigational or marketed products or care improvement programs within 6 weeks prior to or after randomisation 8. known cachexia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess differences in nutritional intake between participants in the control and intervention group - To assess compliance to the pre-thickenend oral nutritional supplement in the intervention group - To assess differences between participants in the control - and intervention group regarding changes in quality of life (QoL), activities of daily living (ADL), micronutritient status, upper - arm and calf circumference, dysphagia severity, pre - and post hydration status, complications as part of (serious) adverse events - To assess product appreciation of the investigational product in the intervention group | — |
Contacts
Public ContactVivienne Huppertz
Maastricht University Medical Center
Outcome results
None listed