Intervention Study to Improve Maternal Handwashing
2022년 9월 22일 업데이트: State University of New York at Buffalo
Effects of Promoting Handwashing With Soap to Improve Maternal Handwashing Behavior During the Neonatal Period
The purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life.
연구 개요
상세 설명
Infectious diseases, such as umbilical cord infection, pneumonia, and sepsis, are responsible for about a quarter of neonatal deaths.
Contaminated hands likely play a role in transmitting pathogens to a neonate, therefore handwashing with soap has the potential to interrupt transmission and improve neonatal health.
The primary objective of this study is to develop and evaluate a scalable, cost-effective handwashing promotion program to improve handwashing behavior among mothers and caregivers of neonates.
The investigators will first conduct a qualitative study to assess the feasibility and acceptability of a set of interventions.
The investigators propose to evaluate the impact of the intervention components, designed as three progressively intense interventions, using a randomized controlled trial with elements of a stepped wedge design.
The study will be conducted in Meru County, Kenya, enrolling a total of 800 pregnant women who seek non-emergency antenatal care at a government health facility during a 1 year period.
Clinic based health care workers and community health volunteers will disseminate the intervention using an interactive storytelling approach.
The focus of the interactions between the health care workers and volunteers and the participant will be on addressing barriers to handwashing through interactive question and answer sessions, rather than a didactic, educational session.
The investigators will assess the impact of interventions on observed maternal and caregiver handwashing behavior and estimate the cost effectiveness for each intervention.
연구 유형
중재적
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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Meru County
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Igembe North And Igembe South Subcounties, Meru County, 케냐
- Government funded antenatal care clinics
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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
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- Pregnant women
- Seeking routine (non-emergency) care at a participating antenatal care clinic during the study period
- Between 30 and 36 weeks pregnant (calculated based on last known menstrual period) when they seek antenatal care
- Live within 30 minutes or 1-2 km one-way travel from the clinic
- Plan to remain in the study area for at least one month post-partum
- Willing to allow the field worker to visit her home following the antenatal care visit on the day of enrollment to conduct baseline assessments at the household
- Sought antenatal care from a qualified medical provider for the first time at or after 28 weeks gestation
Exclusion Criteria:
- Excluded if another member of their household or compound/homestead enrolled in this study
- Excluded if enrolled in the formative research for this 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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Control
Women will receive standard antenatal care but will not receive any additional handwashing promotion, soap, or handwashing device during their enrollment.
At the end of data collection, handwashing with soap will be recommended to participants in the control arm and their families.
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실험적: Clinic
Handwashing promotion from healthcare workers at antenatal care clinic.
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Pregnant women will receive handwashing promotion from a trained facility-based health care worker during her regular antenatal visit at a healthcare clinic.
To the extent feasible, everyone accompanying the pregnant woman will be invited to take part in the behavior change communication session.
The participant will be provided with several bars of soap to take home and she will be encouraged to maintain a designated place for washing hands (with soap and water) at the home.
A poster indicating the key events for handwashing with soap will be posted at the clinic and smaller posters will be given to the participant to post in her home.
A system will be established to send regular SMS messages to the participant promote handwashing with soap during the neonatal period.
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실험적: Clinic + home
Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits.
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Women will receive all components of the clinic-based handwashing promotion in addition to handwashing promotion during 3-4 home visits before their expected delivery date and during the neonatal period from a community health volunteer.
All household members present will be invited to join in the session, with emphasis on including all caregivers of the neonate.
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실험적: Clinic + home + handwashing device
Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits with provision of one handwashing device.
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Women will receive all components of the clinic + home-based handwashing promotion intervention in addition to one handwashing device (i.e.
tap and basin to use as a handwashing station) during the first home visit by the community health volunteer.
The community health volunteer will work with the woman and her family to identify the location where the neonate will be most of the time in order to position the handwashing station as close to the neonate as possible.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
기간: 1 week post-natal
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Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
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1 week post-natal
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Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
기간: 2 weeks post-natal
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Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
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2 weeks post-natal
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
기간: 1 week post-natal
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Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
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1 week post-natal
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Number of participants with soap and water present at a handwashing station
기간: 1 week post-natal
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Observed presence of soap and/or water at a handwashing station
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1 week post-natal
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Cost-effectiveness
기간: 1 month post-partum
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Approximate cost of the intervention per participant
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1 month post-partum
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Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
기간: 2 weeks post-natal
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Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
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2 weeks post-natal
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Number of participants with soap and water present at a handwashing station
기간: 2 weeks post-natal
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Observed presence of soap and/or water at a handwashing station
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2 weeks post-natal
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Pavani K. Ram, M.D., State University of New York at Buffalo
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 (예상)
2016년 2월 1일
기본 완료 (예상)
2016년 12월 1일
연구 완료 (예상)
2018년 8월 1일
연구 등록 날짜
최초 제출
2016년 1월 13일
QC 기준을 충족하는 최초 제출
2016년 5월 3일
처음 게시됨 (추정)
2016년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 9월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 9월 22일
마지막으로 확인됨
2017년 10월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 748140-1
- ESRC P176/2015 (기타 식별자: Amref)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .