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Clinical Trials/NCT05815914
NCT05815914RecruitingNot Applicable

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

Consorci Sanitari Integral2 sites in 1 country182 target enrollmentStarted: April 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
182
Locations
2
Primary Endpoint
Changes in nutritional status

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Changes in nutritional status

Time Frame: Baseline and 12 months

Assessment of changes in nutritional status through the Mini Nutrition Assessment (MNA) at baseline and at 12 months

Secondary Outcomes

  • Adherence to the Mediterranean diet(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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