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Telemedicine for SNAS Patients in COVID-19 Pandemic

NCT04894331 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2021-05-20

No results posted yet for this study

Summary

Restrictions due to Covid-19 pandemic have brought negative social and psychological consequences on people and limited patients' access to hospital care.

In this context, "telemedicine" and, specifically, "tele-nutrition" (in nutritional field) allows remotely monitor and support food allergic patients subjected to restricted diets using information and communication technologies.

The investigators focus attention on patients with diagnosis of Systemic Nickel Allergic Syndrome (SNAS) undergoing low-nickel diet to evaluate nutritional and psychological states through tele-nutrition tools during COVID-19 pandemic.

The aims of this study are: (a) to investigate dietary-nutritional status and, (b) to assess quality of life and adherence to dietary therapy before and after 30-day personalized diet therapy through tele-nutrition tools.

Each subject enrolled in the study goes allergological work-up to assess diagnosis of SNAS and following procedures: (a) face-to-face visit (nutritional visit and quality of life evaluation) concluding with prescription of one of five personalized and balanced dietary plans different for calory intake, (b) video call visit for dietary evaluation and assessment of adherence to diet after 15 days, and (c) video call visit for dietary and quality of life evaluation and assessment of adherence to diet therapy after 30 days (end of study).

Conditions

  • Systemic Nickel Allergic Syndrome

Interventions

OTHER

Dietary intervention

Each patient receives one of 5 dietary plans, different only for energy intake (1400-1600-1800-2000-2100 Kcal/day). The choice depends on the personalized energy needs. The energy requirement is calculated on basal metabolic rate (BMR) of the patient according to Harris \& Benedict's and Schofield's formulas. All dietary plans include foods with low-Ni content. Finally, each patient completes 30-day personalized diet.

OTHER

Video call

Each patient receives a follow-up remote visit through video call 15 and 30 days after the start of the dietary intervention.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Eleonora Nucera, Prof., MD · Università Cattolica del Sacro Cuore, Rome, Italy

  • Antonio Gasbarrini, Prof., MD · Università Cattolica del Sacro Cuore, Rome, Italy

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2020-11-23
Completion
2020-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04894331 on ClinicalTrials.gov