Nutritional Support and Telemedicine

NCT ID: NCT05815914

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-04-30

Brief Summary

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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

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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).

Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Group Type EXPERIMENTAL

app

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

control group

Intervention Type OTHER

Routine nutritional and dietary recommendations will be given.

Interventions

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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

Intervention Type OTHER

control group

Routine nutritional and dietary recommendations will be given.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari Integral

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de Sant Joan Despí, CSI

Sant Joan Despí, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Maria Lecha

Role: CONTACT

+34935531200

Facility Contacts

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Maria Lecha

Role: primary

Other Identifiers

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20/92

Identifier Type: -

Identifier Source: org_study_id

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