Nutritional Support and Telemedicine
Primary Purpose
Malnutrition
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
app
control group
Sponsored by
About this trial
This is an interventional diagnostic trial for Malnutrition focused on measuring Telemedicine, nutritional support, polimorbidity patients
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.
Sites / Locations
- Hospital de Sant Joan Despí, CSIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Changes in nutritional status
Assessment of changes in nutritional status through the Mini Nutrition Assessment (MNA) at baseline and at 12 months
Secondary Outcome Measures
Adherence to the Mediterranean diet
Assessment of adherence to the Mediterranean diet will be carried out with by Predimed questionnaire
Full Information
NCT ID
NCT05815914
First Posted
April 4, 2023
Last Updated
April 4, 2023
Sponsor
Consorci Sanitari Integral
1. Study Identification
Unique Protocol Identification Number
NCT05815914
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consorci Sanitari Integral
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Telemedicine, nutritional support, polimorbidity patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
app
Intervention Description
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
Intervention Name(s)
control group
Intervention Description
Routine nutritional and dietary recommendations will be given.
Primary Outcome Measure Information:
Title
Changes in nutritional status
Description
Assessment of changes in nutritional status through the Mini Nutrition Assessment (MNA) at baseline and at 12 months
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Adherence to the Mediterranean diet
Description
Assessment of adherence to the Mediterranean diet will be carried out with by Predimed questionnaire
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Lecha
Phone
+34935531200
Email
maria.lecha@sanitatintegral.org
Facility Information:
Facility Name
Hospital de Sant Joan Despí, CSI
City
Sant Joan Despí
State/Province
Barcelona
ZIP/Postal Code
08970
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Lecha
Email
maria.lecha@sanitatintegral.org
12. IPD Sharing Statement
Learn more about this trial
Nutritional Support and Telemedicine
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