Nutritional Support and Telemedicine

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Dietetic Education Support, and Nutrition to Chronic Complex Patients With the Usage of a Telemedicine Tool

Conditions
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Malnutrition

Intervention / Treatment
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* Other: app
* Other: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old polymorbidity malnourished patient or patient at risk of malnutrition (MNA≤23.5) patient living at home, with access to and able to use a smartphone and regular internet users (patients or caregivers) patient who agrees to participate in the study by signing the informed consent form Exclusion Criteria: established artificial nutrition advanced dementia admission to a nursing home/social care for a period of >1 month patients not responding to the telematic visits on more than 2 occasions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Other: app<br>* 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<br>|
| Active Comparator: Control group<br> | Other: control group<br>* Routine nutritional and dietary recommendations will be given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nutritional status | Assessment of changes in nutritional status through the Mini Nutrition Assessment (MNA) at baseline and at 12 months | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the Mediterranean diet | Assessment of adherence to the Mediterranean diet will be carried out with by Predimed questionnaire | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, nutritional support, polimorbidity patients