Telemedicine for SNAS Patients in COVID-19 Pandemic

NCT04894331 | Completed

• 1 other identifier: ID 3448
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Food Allergy; COVID-19; Telemedicine; Telenutrition; Quality of Life; Systemic Nickel Allergic Syndrome

Outcome Measures

Primary Outcomes (6)

• Dietary assessment

  Dietary assessment includes questionnaire on 1) drinking alcohol, 2) particular diet (such as vegetarian, vegan or raw food), 3) number of meals per day, 4) same time for meals, 5) place of lunch on non-holiday, 6) frequency of eat away from home (times per week), 7) water intake, and 8) frequency of consumption of foods (desserts, processed meat, red meat, eggs, legumes, milk and derivatives, white meat, bread/pasta/rice, fish fruit and vegetable).

  At enrollment

• Change of body mass index (BMI)

  Collection of weight in kilograms and height in meters will be combined to report BMI in kg/m\^2.

  Change from Baseline BMI at 15 and 30 days

• Change of circumference of wrist

  Collection of anthropometric data: circumference of wrist in centimeters.

  Change from Baseline circumference of wrist at 15 and 30 days

• Change of circumference of arm

  Collection of anthropometric data: circumference of arm in centimeters.

  Change from Baseline circumference of arm at 15 and 30 days

• Change of circumference of waist

  Collection of anthropometric data: circumference of waist in centimeters.

  Change from Baseline circumference of waist at 15 and 30 days

• Change of circumference of hip

  Collection of anthropometric data: circumference of hip in centimeters.

  Change from Baseline circumference of hip at 15 and 30 days

Secondary Outcomes (2)

• State of well-being

  At enrollment, after 30 days

• Adherence to dietary therapy

  After 15 days, after 30 days

Study Arms (1)

SNAS patients

Patients with (a) history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms); (b) positive Ni-patch test; (c) clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet; (d) positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO). Exclusion criteria include (a) age \< 18 years and \>65 years; (b) other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth; (c) diabetes mellitus; (d) hepatic, renal or cardiac dysfunction; (e) thyroid disease or tumour; (f) concomitant treatment with steroids and/or antihistamines in the previous 4 weeks; (g) pregnancy and lactation; (h) smoking, abuse of alcohol, coffee, tea, and cola intake, and (i) inability to give written informed consent.

Other: Dietary intervention; Other: Video call

Interventions

Dietary intervention OTHER

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.

Also known as: Diet therapy

SNAS patients

Video call OTHER

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

Also known as: Telenutrition tool

SNAS patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with (a) history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms); (b) positive Ni-patch test; (c) clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet; (d) positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO).

You may qualify if:

• history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms);
• positive Ni-patch test;
• clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet;
• positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO).

You may not qualify if:

• age \< 18 years and \>65 years;
• other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth;
• diabetes mellitus;
• hepatic, renal or cardiac dysfunction;
• thyroid disease or tumour;
• concomitant treatment with steroids and/or antihistamines in the previous 4 weeks;
• pregnancy and lactation;
• smoking, abuse of alcohol, coffee, tea, and cola intake;
• inability to give written informed consent.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Food Hypersensitivity; COVID-19

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Eleonora Nucera, Prof., MD

  Università Cattolica del Sacro Cuore, Rome, Italy

  PRINCIPAL INVESTIGATOR

• Antonio Gasbarrini, Prof., MD

  Università Cattolica del Sacro Cuore, Rome, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Allergy Unit

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 20, 2021
• Study Start: October 8, 2020
• Primary Completion: November 23, 2020
• Study Completion: November 30, 2020
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)