BEhavioral EConomics for Oral Health iNnovation Pilot Trial (BEECON Pilot)
2019년 3월 1일 업데이트: University of California, San Francisco
Influence of Financial Incentives on Oral Disease Management in Young Children: A Randomized Pilot Trial
This Phase I randomized pilot trial will assess the efficacy of a fixed incentive payment program and drawing incentive payment program versus a control program to promote early childhood caries (ECC) preventive health behaviors (i.e., toothbrushing performance and dental visit attendance) for young children of predominantly Latino parents/caregivers enrolled in/waitlisted for Early Head Start (EHS) home visit programs.
연구 개요
상세 설명
If both groups are acceptable and feasible, the reward group with toothbrushing outcomes at least 20% better than the other one (and the control) will be chosen for a future Phase II/III trial; if they are similar, the fixed monetary reward will be used because it is simpler to explain, monitor, and implement.
연구 유형
중재적
등록 (실제)
36
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Santa Monica, California, 미국, 90405-1828
- Venice Family Clinic Children First Early Head Start
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
6개월 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria for Parent/Caregiver:
- Provide signed and dated informed consent form in English or Spanish.
- Agree to comply with all study procedures and be available for the duration of the study visit.
- Male or female, aged 18 and older.
- Speak, read, and write either English or Spanish.
- Be a parent or caregiver of a child at least 6 months old but less than 3.5 years (42 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the three participating Los Angeles County EHS home visit programs.
- Not be planning to move residence for the next 6 months outside the greater Los Angeles area.
- Own a smartphone with the Google Play or iTunes store and be willing to download the smart powered TB app
- Be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the TB
Exclusion Criteria:
- Known allergic reaction to components of the study product(s).
- Uncooperative or behaviorally unsuited (assessed during a TB prophylaxis at the initial baseline study visit).
- A sibling of a child already enrolled in the study (the family's oldest child in the eligible age range will be the study child).
- Enrolled in foster care.
- Anything else that would place him/her at increased health risk or preclude the individual's full compliance with or completion of the study.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Fixed Incentive
Eligible to earn a weekly payment during the 2-month incentive intervention period.
Possible weekly winnings depend on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will win $5; high adherence threshold (brushing twice per day for 14 days in a week) will win $10.
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The Fixed Incentive intervention is a fixed reward, in which participants are eligible for fixed weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
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실험적: Drawing Incentive
Eligible to earn a weekly drawing entry with different winning probabilities during the 2-month incentive intervention period.
Possible weekly winnings depend on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
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The Drawing Incentive intervention is a drawing reward, in which participants are eligible for weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
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간섭 없음: Control - Delayed Incentive
No rewards during the first 2-months, but information on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
After the Month 2 follow-up visit, may opt to participate in a delayed 2-month open label extension to earn the same monetary rewards the fixed incentive intervention group could earn Baseline through Month 2.
Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean number of qualifying half-day toothbrushing episodes per week
기간: Baseline visit through the Month 2 visit
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Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
(A Bluetooth-recorded toothbrushing episode qualifies if it lasts at least one minute within one of 14 half-day windows in the week.)
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Baseline visit through the Month 2 visit
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Proportion of parents/caregivers attending a dental visit
기간: Month 2 visit
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In the subset of children at baseline with no dental visit in the EHS ChildPlus health module, whether or not the child has a ChildPlus documented dental visit at the two-month follow-up.
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Month 2 visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of weeks the parent/caregiver synced toothbrushing data with the app
기간: Baseline visit through Month 2 visit
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Proportion of weeks the parent/caregiver synced toothbrushing data with the app
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Baseline visit through Month 2 visit
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Mean number of days per week with parent/caregiver-reported twice daily brushing
기간: Baseline visit through the Month 2 visit
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Twice daily brushing with fluoridated toothpaste, based on parent/caregiver-reported frequency diaries
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Baseline visit through the Month 2 visit
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Fluoridated toothpaste use
기간: Baseline visit through the Month 2 visit
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Change in child toothpaste pump weight
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Baseline visit through the Month 2 visit
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Child plaque score
기간: Month 2 visit
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The child's Debris Index component (plaque score) of the Simplified Oral Hygiene Index (Greene and Vermillion) modified to include only maxillary incisor teeth after disclosing with plaque solution.
The scale (which is a mean value) range is 0 (no debris or stain) to 3 (soft debris covering more than two thirds of the exposed tooth surface).
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Month 2 visit
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EHS site participation
기간: Month 0
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Willingness of LA County EHS to sign memoranda of understanding
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Month 0
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EHS staff participation
기간: Month 0
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Willingness of EHS staff participation in assisting with recruitment
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Month 0
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Proportion of parents/caregivers who consent
기간: Baseline visit
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Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data
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Baseline visit
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Proportion of parents/caregivers willing to be randomized
기간: Baseline visit
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Willingness of parents/caregivers to be randomized to a study arm as part of the consenting process
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Baseline visit
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Proportion of parents/caregivers adhering to study procedures
기간: Baseline visit through the Month 2 visit
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Willingness of parents/caregivers to adhere to study procedures, including completing questionnaire instruments, bringing toothbrushing frequency diaries to 2-month follow-up visit, and bringing toothpaste pump to 2-month follow-up visit
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Baseline visit through the Month 2 visit
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Proportion of children who cooperate
기간: Baseline visit through the Month 2 visit
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Willingness of child to cooperate with study procedures, including dental screening, extraoral photo, and plaque assessment
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Baseline visit through the Month 2 visit
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Proportion of parents/caregivers willing to use the toothpaste pump
기간: Baseline visit through the Month 2 visit
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Willingness to use the toothpaste pump (percentage with any use and percentage change in pump weight)
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Baseline visit through the Month 2 visit
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Feasibility of measuring toothbrushing frequency with diaries
기간: Month 2 visit
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Bringing toothbrushing diaries to the follow-up visit and willingness to provide them to study staff
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Month 2 visit
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Feasibility of using toothpaste pump weight as a measure of usage
기간: Month 2 visit
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Bringing the toothpaste pump to the follow-up visit for weighing
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Month 2 visit
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Proportion of parents/caregivers willing to use the disclosing solution
기간: Baseline visit and Month 2 visit
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Willingness of children to comply with the plaque disclosing procedure
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Baseline visit and Month 2 visit
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Proportion of parents/caregivers willing to use photographs for central assessment
기간: Baseline visit and Month 2 visit
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Willingness of the child to allow photographs, the ability to transmit the photographs securely, and the ability of the central clinician to score them reliably and confidently
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Baseline visit and Month 2 visit
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Proportion of parents/caregivers willing to use smart powered toothbrush
기간: Baseline visit through Month 2 visit
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Willingness to use the smart powered toothbrush handle (percentage with any brushing data)
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Baseline visit through Month 2 visit
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Comfort with smart powered toothbrush
기간: Baseline visit through Month 2 visit
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Child and parent comfort level with using the smart powered toothbrush
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Baseline visit through Month 2 visit
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Proportion of parents/caregivers willing to use smartphone app
기간: Baseline visit
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Willingness to download the smartphone app and keep it for the duration of the study
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Baseline visit
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Proportion of parents/caregivers willing to receive text messages
기간: Baseline visit
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Willingness to be contacted with study-related text messages each week during the intervention period
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Baseline visit
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Feasibility of syncing toothbrush to app
기간: Baseline visit
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Successfully synced the toothbrush to app during baseline visit
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Baseline visit
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: James G Kahn, MD, MPH, University of California, San Francisco
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 5월 10일
기본 완료 (실제)
2017년 8월 13일
연구 완료 (실제)
2018년 3월 19일
연구 등록 날짜
최초 제출
2019년 2월 14일
QC 기준을 충족하는 최초 제출
2019년 3월 1일
처음 게시됨 (실제)
2019년 3월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 3월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 3월 1일
마지막으로 확인됨
2019년 3월 1일
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. .