- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04367337
Health Behavior Change During COVID-19 Pandemic
Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Fajara, 감비아
- London School of Hygiene and Tropical Medicine (in collaboration with MRC Unit The Gambia at LSHTM)
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Berlin, 독일
- Freie Universität Berlin
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Cluj-Napoca, 루마니아
- Babes-Bolyai Unversity
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Serdang, 말레이시아
- Perdana University
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Zürich, 스위스
- University of Zurich
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Singapore, 싱가포르
- Nanyang Technological University
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Ramat Gan, 이스라엘
- Bar-Ilan University
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Padova, 이탈리아
- University of Padova
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Beijing, 중국
- Peking University
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Fredericton, 캐나다
- University of New Brunswick
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Lisbon, 포르투갈
- University of Lisbon
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Lower Silezia
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Wroclaw, Lower Silezia, 폴란드, 53-328
- SWPS University of Social Sciences and Humanities
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Bordeaux, 프랑스
- University of Bordeaux
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Melbourne, 호주
- The University of Melbourne
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- adults (from general population) who provided informed consent to participate
Exclusion Criteria:
- younger than <18 years old
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Poland
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Australia
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Canada
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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China
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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France
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Gambia
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Germany
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Israel
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Italy
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Malaysia
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Portugal
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Romania
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Singapore
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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Switzerland
Adults, general population, N = 400
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Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Handwashing adherence
기간: 1 month
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The 12-item self-report measure of adherence to handwashing guidelines across situations (e.g., after visiting public spaces, after touching garbage, etc.) based on the guidelines issued by the World Health Organization and the Centers for Disease Control and Prevention.
The responses are provided on a 4-point scale, ranging from 1 (strongly disagree) to 4 (strongly agree).
Higher scores indicate better outcomes (the higher level of adherence to handwashing guidelines).
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1 month
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Frequency of handwashing
기간: 1 month
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The 1-item self-report measure of the frequency of handwashing (for at least 20 seconds, all surfaces of the hands) daily.
The responses are provided on a 4-point scale, ranging from 1 (less than once) to 5 (more than 10 times).
Higher scores indicate better outcomes (the higher frequency of handwashing).
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1 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Self-efficacy
기간: 1 month
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4 self-efficacy questionnaire items; mean item score ranging from 1 to 4, higher scores indicate stronger self-efficacy
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1 month
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Risk perception
기간: 1 month
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3 questionnaire items to assess risk perception; mean item score ranging from 1 to 5, higher scores indicate higher risk perception
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1 month
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Outcome expectancy
기간: 1 month
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4 items assessing positive (1 item) and negative (1 items) outcome expectancies; mean item scores ranging from 1 to 4, higher scores indicate more positive outcome expectancies
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1 month
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Intention
기간: 1 month
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2 questionnaire items assessing intention to adhere to handwashing recommendations; mean item scores ranging from 1 to 4, higher scores indicate stronger intention to wash hands (for at least 20 seconds, all surfaces of the hands)
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1 month
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Planning
기간: 1 month
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2 questionnaire items assessing action planning (1 item) and coping planning (1 item); mean item scores ranging from 1 to 4, higher scores indicate a higher level of self-reported planning
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1 month
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Action control
기간: 1 month
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3 questionnaire items assessing a facet of action control, namely self-monitoring; mean item scores ranging from 1 to 4, higher scores indicate a higher level of self-reported monitoring of handwashing behavior
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1 month
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Perceived effectiveness of hand hygiene
기간: 1 month
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1 questionnaire item assessing perceptions of handwashing as an effective means of preventing coronavirus SARS-CoV-2 infection; item scores ranging from 1 to 4, higher scores indicate a higher level of perceived effectiveness of hand hygiene
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1 month
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Anxiety
기간: 1 month
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7-item self-report scale (Generalized Anxiety Disorder, GAD-7) scale to assess anxiety symptoms; mean item scores ranging from 1 to 4, higher scores indicate a higher level of generalized anxiety
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1 month
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Country-level COVID-19 morbidity and mortality rates
기간: 60 days
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The daily cumulative numbers for COVID-19 morbidity and mortality in the study countries.
Published daily as the Situation Report by World Health Organization, starting on 21 January 2020.
Higher numbers indicate the higher cumulative COVID-19 morbidity and mortality rates in the country.
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60 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Aleksandra Luszczynska, PhD, SWPS University of Social Sciences and Humanities
간행물 및 유용한 링크
일반 간행물
- Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.
- World Health Organization. Coronavirus disease (COVID-19) advice for the public. 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public
- Centers for Disease Control and Prevention. When and how to wash your hands. 2020. https://www.cdc.gov/handwashing/when-how-handwashing.html
- Reyes Fernandez B, Knoll N, Hamilton K, Schwarzer R. Social-cognitive antecedents of hand washing: Action control bridges the planning-behaviour gap. Psychol Health. 2016 Aug;31(8):993-1004. doi: 10.1080/08870446.2016.1174236. Epub 2016 Apr 26.
- Ruiter RAC, Abraham C, Kok G. Scary warnings and rational precautions: A review of the psychology of fear appeals. Psychol Health. 2011;11(1): 613-630. doi: 10.1080/08870440108405863
- Luszczynska A, Szczuka Z, Abraham C, Baban A, Brooks S, Cipolletta S, Danso E, Dombrowski SU, Gan Y, Gaspar T, de Matos MG, Griva K, Jongenelis MI, Keller J, Knoll N, Ma J, Miah MAA, Morgan K, Peraud W, Quintard B, Shah V, Schenkel K, Scholz U, Schwarzer R, Siwa M, Taut D, Tomaino SCM, Vilchinsky N, Wolf H. The Interplay Between Strictness of Policies and Individuals' Self-Regulatory Efforts: Associations with Handwashing During the COVID-19 Pandemic. Ann Behav Med. 2022 Apr 2;56(4):368-380. doi: 10.1093/abm/kaab102.
- Szczuka Z, Abraham C, Baban A, Brooks S, Cipolletta S, Danso E, Dombrowski SU, Gan Y, Gaspar T, de Matos MG, Griva K, Jongenelis M, Keller J, Knoll N, Ma J, Miah MAA, Morgan K, Peraud W, Quintard B, Shah V, Schenkel K, Scholz U, Schwarzer R, Siwa M, Szymanski K, Taut D, Tomaino SCM, Vilchinsky N, Wolf H, Luszczynska A. The trajectory of COVID-19 pandemic and handwashing adherence: findings from 14 countries. BMC Public Health. 2021 Oct 5;21(1):1791. doi: 10.1186/s12889-021-11822-5.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 3228-1BPSYPSBEH-30
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The lead researchers in 14 countries will have full access to data collected across the countries.
In line with the Consortium Agreement (v2, 16th Jul 2020) data will be openly available under following conditions:
De-identified individual participant data that underline the results reported in publications; individual-level aggregated data (e.g., sum scores for scales) used for main analyses in respective publications; available following the publication, no end date of availability; available for analyses that are conducted to achieve aims in the approved proposal.
Due to local regulations, there are exceptions in terms of data sharing rules (stated above):
- AUSTRALIA: Data from Australia will be available for 5 years after collection.
- GERMANY, SWITZERLAND: Instead of individual-level sum scores, variance-covariance matrices will be shared.
- MALAYSIA: Data will not be shared.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
건강 행동에 대한 임상 시험
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH) 그리고 다른 협력자들완전한
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University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수
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Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH) 그리고 다른 협력자들아직 모집하지 않음
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University아직 모집하지 않음Focus Health 임산부
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University College London HospitalsUniversity College, London완전한
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Gümüşhane UniversıtyKaradeniz Technical University완전한Kelkit District State Hospital Home Health Unit에 등록 | 가정 간호 환자칠면조
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University of Haifa완전한산후 기간 | 산모 정신 건강 | Parenting / Maternal Behavior | 초산 (첫 아이를 임신한 산모) | 산후 우울 증상이스라엘
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The Mediterranean Institute for the Advance of...Carlos III Health Institute; European Regional Development Fund; Andalusian Regional Ministry... 그리고 다른 협력자들아직 모집하지 않음
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Hopital MontfortChildren's Hospital of Eastern Ontario Research Institute모병열 스트레스 장애 | 1차 의료 | 환경 노출 | 위험 감소 행동 | 공중 위생 | 열 노출 | 기후 변화 | 예방 건강 서비스(PREV HEALTH SERV) | 건강한 과목캐나다
No intervention에 대한 임상 시험
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Shanghai Yueyang Integrated Medicine Hospital아직 모집하지 않음
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Second Affiliated Hospital, School of Medicine,...모집하지 않고 적극적으로
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Guangzhou Women and Children's Medical Center아직 모집하지 않음NEC - 괴사성 장염
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Monash UniversityThe Alfred; Melbourne Sexual Health Centre모병매독중국, 호주, 남아프리카, 영국
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IRCCS San Raffaele모집하지 않고 적극적으로