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Information and Communication Technologies (ICTS) in Dentistry for SUS

12 marca 2021 zaktualizowane przez: Mariana Minatel Braga, University of Sao Paulo

Using Information and Communication Technologies (ICTs) to Solve the Repressed Demand for Primary Dental Care in the SUS Due to the COVID-19 Pandemic

At the time of the COVID-19 pandemic, thousands of children had their dental care interrupted or postponed, generating a pent-up demand for primary care. In order to minimize the impact of this outage of face-to-face care, information and communication technologies could be an alternative and even likely to be envisioned within the Brazilian Unified Health System (SUS). In this sense, this study sought to show the impact of the use of information and communication technologies (ICT) in the resolution of the pent-up demand for primary dental care to children in the SUS, due to the COVID-19 pandemic, proposing the use of telemonitoring, teleorientation and telescreening to resolve and address demands arising from this outage in primary elective care. The impact of the use of these strategies will be measured in terms of problem-solving, reduction of waiting time to resolve complaints and caregivers' perception about received care. For this, two clinical studies were designed and a primarily trial-based economic evaluation was planned. Mathematical models will be used to transpose these results into the reality of the SUS, in view of the State Health Secretariat of São Paulo and different Brazilian scenarios. Finally, the investigators also aim to study the possibility of implementing these technologies mentioned in the daily life of the SUS, even after a pandemic, and to check the possibility of incorporating and costing them, as well as exploring possible social impact and relationship with possible inequities in health.

Przegląd badań

Szczegółowy opis

Project Objectives:

This proposal has as a general objective to show the impact of the use of information and communication technologies (ICT) on the resolution of the pent-up demand for primary dental care to children in the SUS, due to the COVID-19 pandemic.

To this do so, the following specific objectives are defined:

  1. To identify the pent-up demand for the outage of dental care and the benefits and difficulties, as well as the perception of users, in the implementation of new strategies of non-face-to-face care based on technology (teleservice), using a primary care cell unit for children and prospecting, through models, this situation for the scenario of the Unified Health System (SUS).
  2. Perform different forms of economic evaluation to measure whether the gains achieved with the implementation of teleservice (telescreening, teleorientation and telemonitoring) compensate for the additional costs possibly associated with it, or whether teleservice modalities are associated with long-term resource savings, taking into account the implementation sized for the Brazilian public health system.
  3. Explore how the introduction of these technologies could benefit the SUS in the trans and post-pandemic period, contribute to the correction of possible inequities in health care and other social aspects, as well as result in possible differences when different Brazilian scenarios are explored.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

368

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Mariana M Braga, PhD
  • Numer telefonu: 55 11 30917835
  • E-mail: mmbraga@usp.br

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

      • São Paulo, Brazylia, 05508000
        • Rekrutacyjny
        • University of Sao Paulo
        • Kontakt:
          • Mariana Minatel Braga, Phd
          • Numer telefonu: 992014818
          • E-mail: mmbraga@usp.br
        • Kontakt:
          • Maria Eduarda Franco Viganó, Graduation
          • Numer telefonu: (11)99518-1964
          • E-mail: maria.vigano@usp.br

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

3 lata do 13 lat (Dziecko)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

- Children from 3 to 13 years old who are involved in clinical studies and who already undergo follow-up from 6 to 60 months in the mobile dental unit.

Exclusion Criteria:

  • Guardian´s participants) who do not accept to participate in the research and if participants accept.
  • Children who do not assent with participation in the research (when already literate). - For children aged 3 to 6 years, included in the research, the waiver of the need to fill out the term of free and informed assent was requested, considering that these children are not literate and would not be able to write, to assent with the participation. t

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Intervention
In the intervention group there will be the application of the intervention - use of telemonitoring and teleorientation applied to children in primary care in Dentistry.
Teleservice will be performed through a digital platform (Video for Health" - V4H). The service will consist of: a) recognition of the condition identified in the pandemic period, including updates on medical history, current oral health condition, search for dental care in other units, need for referral, change of hygiene habits, b) realization of diet guidance, hygiene and other necessary habits, made from a situational recognition of such habits, c) targeting the needs presented, in which individualized counselling will be given seeking to meet the demand presented by that family nucleus. A dental form developed on the digital platform Google Forms will serve as a guide for the performance of the service and where the collected data will be formally recorded. The guidelines, although individualized for the needs of each child, will follow a pre-defined and standardized structure and based on the best evidence available in the subject.
Aktywny komparator: Waiting list
In the control group, children waiting to be booked to the intervention (in implementation in the unit because of the pandemic) will be evaluated for the outcomes. Only after the evaluation, the control group's children will be invited to perform the teleconsultation (proposed intervention).
No intervention (at least, until the time frame for outcome assessment)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Family/patient´s perception about the dental care
Ramy czasowe: 2 weeks after intervention (or one week of waiting - in the case of the control group)

Evaluation of the quality of dental care to be measured by the SERVQUAL questionnaire (a multi-dimensional research instrument) - total of 22 items and 5 dimensions, comprising 4 items to capture tangibles, 5 items to capture reliability, 4 items for responsiveness, 4 items for assurance and 5 items to capture empathy.

A total of 100 points is allocated among the five dimensions. The participants evaluate the degree to which they perceived the proposed service. To identify participants' perceptions, one item asked, "How do you feel about these service attributes that are already provided?", which was scored on a 5-point Likert-type scale of "very bad (1)" to "very good (5)."

2 weeks after intervention (or one week of waiting - in the case of the control group)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Increment in caries experience since the interruption of dental care
Ramy czasowe: 1 year after intervention
Clinical examination focused using dmft and DMFT indices and comparison to those. An previously recorded in participant´s records, resulting in the difference between the indices between these moments (DMFT+dmft final - DMFT+dmft when treatment was interrupted). An examiner unaware of baseline conditions will assess these indices.
1 year after intervention
Increment or changes in the needs for dental treatment
Ramy czasowe: 1 year after intervention
Clinical examination focused in detecting if there is need for dental treatment or not (including untreated caries, need for restoration repair, need of gingival or periodontal treatment, need for extractions for any reason). An examiner unware of baseline conditions will assess such needs.
1 year after intervention
Demand resolution after intervention
Ramy czasowe: 2 weeks after intervention
Interview for checking about the resolution of demands pointed out during the baseline consultation.
2 weeks after intervention
Need for reorientation about oral hygiene
Ramy czasowe: 2 weeks, 3 months, 6 months, 1 year after intervention
Interview for checking doubts about oral hygiene and checklist of items to be accomplished during oral hygiene demonstrated by child. An external examiner will evaluate all listed items. In case of any one is not checked, the need of reorientation is considered.
2 weeks, 3 months, 6 months, 1 year after intervention
Perception of caregivers regarding primary care and dental care.
Ramy czasowe: 2 weeks after intervention
Semi-structured interviews, applied with guided questions to try to assess participants' and parents' perception, as well as potential barriers and facilitators associated with dental care during the pandemic period with the caregivers of the children who followed the teleservice. For this, individual interviews will be recorded and transcribed.
2 weeks after intervention

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Mariana M Braga, PhD, USP

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 grudnia 2020

Zakończenie podstawowe (Oczekiwany)

30 czerwca 2021

Ukończenie studiów (Oczekiwany)

30 czerwca 2022

Daty rejestracji na studia

Pierwszy przesłany

8 marca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 marca 2021

Pierwszy wysłany (Rzeczywisty)

15 marca 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 marca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 marca 2021

Ostatnia weryfikacja

1 marca 2021

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • TeleDent-COVID19

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Telemonitoring and teleorientation

3
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