Nutritional Support and Telemedicine

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815914
• Other study ID #: 20/92
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2023
• Source: Consorci Sanitari Integral
• Contact: Maria Lecha
• Phone: +34935531200
• Email: maria.lecha[@]sanitatintegral.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• app
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
• control group
Routine nutritional and dietary recommendations will be given.

Locations

Country	Name	City	State
Spain	Hospital de Sant Joan Despí, CSI	Sant Joan Despí	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari Integral

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence to the Mediterranean diet	Assessment of adherence to the Mediterranean diet will be carried out with by Predimed questionnaire	12 months