Telemedicine for SNAS Patients in COVID-19 Pandemic
Condition: Systemic Nickel Allergic Syndrome
MeSH terms: COVID-19
Study type: Observational

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).
    

Detailed description: 
      There are no previous studies focused on the tele-nutrition for the evaluation of
      dietary-nutritional status of patients suffered from Systemic Nickel Allergic Syndrome
      (SNAS).

      The aims of this study are (a) to investigate dietary-nutritional status (primary outcome)
      and, (b) to assess quality of life (QoL) and adherence to dietary therapy (secondary
      outcomes) of SNAS patients before and after personalized diet therapy through tele-nutrition
      tools at time of COVID-19 pandemic.

      The investigators perform a prospective, single-center, observational study enrolling SNAS
      patients in order to evaluate dietary-nutritional status and QoL, before and after 30-day
      personalized diet therapy, and adherence to low Ni diet, through tele-nutrition tools, during
      COVID-19 pandemic.

      The study is performed at the Allergology Unit and Dietetics and Clinical Nutrition Unit of
      Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy.

      All enrolled patients give their signed informed consent to participation in the study.

      The investigators enroll patients with (a) history of SNAS (coexistence of typical cutaneous
      and gastrointestinal symptoms); (b) positive Nickel (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.

      Patients go pre-diet face-to-face visit (time 0, T0), complete 30-day personalized diet and,
      then, go follow-up remote visit through video call (time 2, T2). A further video call is
      performed 15 days after the start of the diet therapy treatment (time 1, T1).

      The study uses the commercially available online platform Microsoft Teams, which is included
      in the Fondazione Policlinico Universitario A. Gemelli IRCCS's Microsoft Office 365 package.

      Variables The investigators select two primary outcome measurements (dietary assessment and
      anthropometric data) to evaluate dietary-nutritional status of SNAS patients. Moreover, the
      investigators adopt Short-Form 36-Item Health Survey (SF-36v2) questionnaire as tool to
      evaluate QoL (secondary outcome). Finally, adherence to diet therapy (secondary outcome) is
      investigated through video call at T1 and T2.

      Measurement

      Study procedures:

      T0 face-to-face visit:

        -  Dietary assessment: nutritional history and eating habits.

        -  Collection of anthropometric data.

        -  QoL evaluation. Each patient answers SF-36v2 (Italian version) questionnaire. At the end
           of visit, each patient receives one of 5 dietary plans, different only for energy intake
           (1400-1600-1800-2000-2100 Kcal/day). The choice depended on the personalized energy
           needs.

      All dietary plans include foods with low-Ni content.

      T1 video call visit:

        -  Dietary assessment: collection of anthropometric data.

        -  Assessment of adherence to dietary therapy through question "How many days a week did
           the participant adhere to the prescribed dietary treatment? - Two possible mutually
           exclusive answers: 1) <5 days a week, 2) ≥ 5 days a week.

      T2 video call visit:

        -  Dietary evaluation: collection of anthropometric data.

        -  Assessment of adherence to the dietary treatment.

        -  QoL evaluation.
    

Intervention name(s): Dietary intervention; Video call
Intervention type(s): Other; Other
Intervention description(s): 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.; Each patient receives a follow-up remote visit through video call 15 and 30 days after the start of the dietary intervention.
Other intervention name(s): Diet therapy; Telenutrition tool
Observational model: Cohort
Time perspective: Prospective
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).
      
Keywords: Food Allergy; COVID-19; Telemedicine; Telenutrition; Quality of Life; Systemic Nickel Allergic Syndrome