An interventional study of app and control group in Malnutrition, sponsored by Consorci Sanitari Integral. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Consorci Sanitari Integral · Not applicable, Interventional, and Diagnostic
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 patients"(CCP) in order to improve their nutritional status and evaluate the level of adherence to dietetic counseling.
The aim is to evaluate the usage of an APP and track the nutritional status of "chronic complex patients"(CCP) 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 hospital.In the first stage, there's been an elaboration of the contents of the APP. For the assessment of the strategy of food education, two groups of patients will be defined(Intervention 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 (MNA\<23,5), 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).
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's planned enrollment of 182 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Consorci Sanitari Integral is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: app
Other: control group
The app will include a nutritional education programme through the APP throughout the study. At 2, 4, 6 and 8 months data will be collected through a telematics questionnaire
Routine nutritional and dietary recommendations will be given.
Changes in nutritional status
Assessment of changes in nutritional status through the Mini Nutrition Assessment (MNA) at baseline and at 12 months
Time frame: Baseline and 12 months
Adherence to the Mediterranean diet
Assessment of adherence to the Mediterranean diet will be carried out with by Predimed questionnaire
Time frame: 12 months
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Consorci Sanitari Integral