- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04798599
Information and Communication Technologies (ICTS) in Dentistry for SUS
Using Information and Communication Technologies (ICTs) to Solve the Repressed Demand for Primary Dental Care in the SUS Due to the COVID-19 Pandemic
연구 개요
상태
상세 설명
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:
- 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).
- 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.
- 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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mariana M Braga, PhD
- 전화번호: 55 11 30917835
- 이메일: mmbraga@usp.br
연구 연락처 백업
- 이름: Karina Haibara
- 전화번호: 55 11 30917835
- 이메일: karina.natal@usp.br
연구 장소
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São Paulo, 브라질, 05508000
- 모병
- University of Sao Paulo
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연락하다:
- Mariana Minatel Braga, Phd
- 전화번호: 992014818
- 이메일: mmbraga@usp.br
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연락하다:
- Maria Eduarda Franco Viganó, Graduation
- 전화번호: (11)99518-1964
- 이메일: maria.vigano@usp.br
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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활성 비교기: 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).
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No intervention (at least, until the time frame for outcome assessment)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Family/patient´s perception about the dental care
기간: 2 weeks after intervention (or one week of waiting - in the case of the control group)
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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)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Increment in caries experience since the interruption of dental care
기간: 1 year after intervention
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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.
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1 year after intervention
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Increment or changes in the needs for dental treatment
기간: 1 year after intervention
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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.
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1 year after intervention
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Demand resolution after intervention
기간: 2 weeks after intervention
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Interview for checking about the resolution of demands pointed out during the baseline consultation.
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2 weeks after intervention
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Need for reorientation about oral hygiene
기간: 2 weeks, 3 months, 6 months, 1 year after intervention
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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.
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2 weeks, 3 months, 6 months, 1 year after intervention
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Perception of caregivers regarding primary care and dental care.
기간: 2 weeks after intervention
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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.
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2 weeks after intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mariana M Braga, PhD, USP
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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