Nutritional Support and Telemedicine

Not Applicable

Recruiting

• Conditions: Malnutrition
• Interventions: Other: app; Other: control group

• Registration Number: NCT05815914
• Lead Sponsor: Consorci Sanitari Integral

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 patients"(CCP) 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 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).

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	app	-
Control group	control group	-

Primary Outcome Measures

Name	Time	Method
Changes in nutritional status	Baseline and 12 months	Assessment of changes in nutritional status through the Mini Nutrition Assessment (MNA) at baseline and at 12 months

Secondary Outcome Measures

Name	Time	Method
Adherence to the Mediterranean diet	12 months	Assessment of adherence to the Mediterranean diet will be carried out with by Predimed questionnaire

Trial Locations

Locations (1)

Hospital de Sant Joan Despí, CSI; 🇪🇸 Sant Joan Despí, Barcelona, Spain