Nutritional Support and Telemedicine
Dietetic Education Support, and Nutrition to Chronic Complex Patients With the Usage of a Telemedicine Tool
1 other identifier
interventional
182
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 4, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedApril 18, 2023
April 1, 2023
1.1 years
April 4, 2023
April 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Adherence to the Mediterranean diet
12 months
Study Arms (2)
Intervention group
EXPERIMENTALControl group
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- \>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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Sant Joan Despí, CSI
Sant Joan Despí, Barcelona, 08970, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2023
First Posted
April 18, 2023
Study Start
April 1, 2022
Primary Completion
April 30, 2023
Study Completion
April 30, 2024
Last Updated
April 18, 2023
Record last verified: 2023-04