Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414200
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-02
Brief Title:
Nutritional Care After Discharge in Children Term Born-18years Old
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Nutritional Care After Hospital Discharge
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NutriCAD
Brief Summary:
The goal of this stepped wedge cluster randomized trial is to compare nutritional care after discharge to an intervention in children term born - 18 years old discharged with newly initiated nutritional care
The main question it aims to answer is
To investigate whether a tailored nutritional care follow-up program in children who are being discharged from the hospital with nutritional support improves nutritional intake and status as well as feeding behavior and quality of life QoL in children and their parents Furthermore the effect on parental stress anxiety depression and post-traumatic stress PTSD as well as QoL will be assessed with and without a tailored nutritional care follow-up program
The main question it aims to answer is
To investigate whether a tailored nutritional care follow-up program in children who are being discharged from the hospital with nutritional support improves nutritional intake and status as well as feeding behavior and quality of life QoL in children and their parents Furthermore the effect on parental stress anxiety depression and post-traumatic stress PTSD as well as QoL will be assessed with and without a tailored nutritional care follow-up program
Detailed Description:
All subjects both in the usual care and intervention group will be treated with the standard nutritional protocols of these individual hospitals during hospitalization After hospital discharge the treatments of the intervention and the control group will entail the procedures as described below
Intervention group The intervention consists of a tailored nutritional follow-up plan including a parent empowerment program made by a multidisciplinary support team primarily responsible clinician dietician psychologist and if indicated a speech therapist At discharge and follow-up at 6 12 and 18 weeks after discharge food diaries including growth and questionnaires relating to feeding behaviour and parental stress are filled out by parentscaregivers
One week before the planned outpatient visit of the patient and their parents questionnaires will be sent with preferred software available in ErasmusMC ICT infrastructure through e-mail The findings gathered from these nutritional data and questionnaires will be visualized on a dashboard visible to parents and the caregivers to discuss and help resolve the most relevant problems with the parents during the follow-up moments During the outpatient visit the growth and body composition of the child will also be assessed
The nutritional support team will discuss the outcomes of the questionnaires and make tailored advice based on the problems parents have reported The dietician will discuss this tailored advice with the children andor parents based on the growth the nutritional intake of the child and the problems parents have reported regarding the feeding behaviour of the child and their parental distress Subsequently the dietician will provide recommendations and psychoeducation to parents andor patients in order to improve the nutritional status
At 6 months after discharge followup measurements such as growth duration and frequency of nutritional support food diary feeding behaviour of the child QoL of the child parental stress and QoL will be gathered
Evaluation and treatment other than follow-up at 6 8 and 12 weeks after discharge with one of the health care professionals are on indication and data will not be collected
The intervention differs from the usual care because follow-up is at standard time periods In the usual care this is not regulated Nutritional support is given in a multidisciplinary team including a psychologist but in the pilot study we saw collaboration with the pediatrician and speech therapist only In the intervention we also focuses on parenteral stress which is new and different from usual care
Usual care group Nutritional advice in the usual care group will be given after discharge and follow-up according to standard practices At 6 months after discharge an evaluation will be done equal to the intervention group To collect information about the number of readmissions to the hospital and reason of admission visits to a health-care provider and growth parameters parents are asked to fill in a logbook to collect this data between discharge and 6 months follow-up This method has been chosen because these are parameters that are difficult to remember at the visit 6 months after discharge
The following age-adjusted and validated questionnaires will be used to assess emotional functioning the pediatric feeding disorders and parenteral stress
Intervention group The intervention consists of a tailored nutritional follow-up plan including a parent empowerment program made by a multidisciplinary support team primarily responsible clinician dietician psychologist and if indicated a speech therapist At discharge and follow-up at 6 12 and 18 weeks after discharge food diaries including growth and questionnaires relating to feeding behaviour and parental stress are filled out by parentscaregivers
One week before the planned outpatient visit of the patient and their parents questionnaires will be sent with preferred software available in ErasmusMC ICT infrastructure through e-mail The findings gathered from these nutritional data and questionnaires will be visualized on a dashboard visible to parents and the caregivers to discuss and help resolve the most relevant problems with the parents during the follow-up moments During the outpatient visit the growth and body composition of the child will also be assessed
The nutritional support team will discuss the outcomes of the questionnaires and make tailored advice based on the problems parents have reported The dietician will discuss this tailored advice with the children andor parents based on the growth the nutritional intake of the child and the problems parents have reported regarding the feeding behaviour of the child and their parental distress Subsequently the dietician will provide recommendations and psychoeducation to parents andor patients in order to improve the nutritional status
At 6 months after discharge followup measurements such as growth duration and frequency of nutritional support food diary feeding behaviour of the child QoL of the child parental stress and QoL will be gathered
Evaluation and treatment other than follow-up at 6 8 and 12 weeks after discharge with one of the health care professionals are on indication and data will not be collected
The intervention differs from the usual care because follow-up is at standard time periods In the usual care this is not regulated Nutritional support is given in a multidisciplinary team including a psychologist but in the pilot study we saw collaboration with the pediatrician and speech therapist only In the intervention we also focuses on parenteral stress which is new and different from usual care
Usual care group Nutritional advice in the usual care group will be given after discharge and follow-up according to standard practices At 6 months after discharge an evaluation will be done equal to the intervention group To collect information about the number of readmissions to the hospital and reason of admission visits to a health-care provider and growth parameters parents are asked to fill in a logbook to collect this data between discharge and 6 months follow-up This method has been chosen because these are parameters that are difficult to remember at the visit 6 months after discharge
The following age-adjusted and validated questionnaires will be used to assess emotional functioning the pediatric feeding disorders and parenteral stress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None