Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815914
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-04-04
Brief Title:
Nutritional Support and Telemedicine
Sponsor:
Consorci Sanitari Integral
Organization:
Consorci Sanitari Integral
Study Overview
Official Title:
Dietetic Education Support and Nutrition to Chronic Complex Patients With the Usage of a Telemedicine Tool
Status:
RECRUITING
Status Verified Date:
2023-04
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:
None
Brief Summary:
The aim of this clinical trial is to assess the implementation of an APP to track the nutritional status and diet habits of chronic complex patientsCCP in order to improve their nutritional status and evaluate the level of adherence to dietetic counseling
Detailed Description:
The aim is to evaluate the usage of an APP and track the nutritional status of chronic complex patientsCCP in order to improve their nutritional status
This is a study of an experimental design referring to a controlled randomized trial with CCP in the Moises Broggi hospitalIn the first stage theres been an elaboration of the contents of the APP For the assessment of the strategy of food education two groups of patients will be definedIntervention group IG Control group CG In each group there will be 91 subjects meaning a total of 182 patients Inclusion criteria 18 years old CCP with either malnutrition or risk of malnutrition MNA235 therapeutic profile 3 living at home with full accessibility and capable to use a smartphone and usual internet consumers patients or caregivers and who need to sign the informative consent The inclusion of this study will be made through a random sampling and patients will be assigned to IG or CG All patients will undergo an initial evaluation a follow-up visit after the first 6 months and then a final visit after 12 months The intervention group will also contain an educational and nutritional program by means of the APP throughout the entire study and data will be collected through a telematic questionnaire between visits The variables to study are nutritional diet clinics social and valorisation tools ICT IG
This is a study of an experimental design referring to a controlled randomized trial with CCP in the Moises Broggi hospitalIn the first stage theres been an elaboration of the contents of the APP For the assessment of the strategy of food education two groups of patients will be definedIntervention group IG Control group CG In each group there will be 91 subjects meaning a total of 182 patients Inclusion criteria 18 years old CCP with either malnutrition or risk of malnutrition MNA235 therapeutic profile 3 living at home with full accessibility and capable to use a smartphone and usual internet consumers patients or caregivers and who need to sign the informative consent The inclusion of this study will be made through a random sampling and patients will be assigned to IG or CG All patients will undergo an initial evaluation a follow-up visit after the first 6 months and then a final visit after 12 months The intervention group will also contain an educational and nutritional program by means of the APP throughout the entire study and data will be collected through a telematic questionnaire between visits The variables to study are nutritional diet clinics social and valorisation tools ICT IG
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