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Nutritional Support and Telemedicine

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05815914
Enrollment
182
Registered
2023-04-18
Start date
2022-04-01
Completion date
2024-04-30
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Telemedicine, nutritional support, polimorbidity patients

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).

Interventions

OTHERapp

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

OTHERcontrol group

Routine nutritional and dietary recommendations will be given.

Sponsors

Consorci Sanitari Integral
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in nutritional statusBaseline and 12 monthsAssessment of changes in nutritional status through the Mini Nutrition Assessment (MNA) at baseline and at 12 months

Secondary

MeasureTime frameDescription
Adherence to the Mediterranean diet12 monthsAssessment of adherence to the Mediterranean diet will be carried out with by Predimed questionnaire

Countries

Spain

Contacts

Primary ContactMaria Lecha
maria.lecha@sanitatintegral.org+34935531200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026