Clinical trial NCT05815914: Nutritional Support and Telemedicine
Official title: Dietetic Education Support, and Nutrition to Chronic Complex Patients With the Usage of a Telemedicine Tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Keywords: Telemedicine
nutritional support
polimorbidity patients
Lead sponsor: Consorci Sanitari Integral
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in nutritional status
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Adherence to the Mediterranean diet
timeFrame: 12 months
Other outcomes:
Locations:
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí, CSI
state: Barcelona
Study officials:
References: