- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01801059
Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer
Patient Activation To Increase Colon Cancer Screening (THE CHAT STUDY)
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. To test a patient activation intervention to improve colorectal cancer (CRC) screening rates using fecal occult blood test (FOBT) among male and female patients 50 years and older from the East Central Columbus Neighborhood Health Center.
SECONDARY OBJECTIVES:
I. To assess if there is a change in knowledge and attitudes about CRC screening after watching the educational video.
II. To assess the effectiveness of providing communication skills training for improving discussion focusing on CRC screening during the patient-provider visit.
OUTLINE: Patients are randomized to 1 of 2 arms prior to a medical visit.
ARM I (Education only): Patients receive CRC and CRC screening information by an educational video and a brochure with healthy hints to prevent CRC.
ARM II (Education and patient activation): Patients receive CRC and CRC screening information and communication skills training (patient activation) intervention by educational video and brochure and a brochure about healthy hints to prevent CRC.
After the medical visit, patients' medical records are reviewed at 1 month and 2 months after the visit to document CRC screening completion.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ohio
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Columbus, Ohio, 미국, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient is 50+ years of age
- Patient is in need of CRC screening
- Patient is in good health (e.g. no contraindications to having CRC screening, such as a history of colorectal cancer, congenital heart failure, renal failure, dialysis, dementia, severe arthritis, etc.)
- Patient is not pregnant
- Patient is able to speak, read, and understand English
Exclusion Criteria:
- Patient is within CRC screening guidelines
- Patient is at high risk for CRC
- Patient cannot understand English
- Patient cannot complete a CRC screening test
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Arm I education CRC and CRC screening
Educational intervention: Patients receive CRC and CRC screening information from an educational video and received a brochure focused on healthy hints to prevent CRC.
Questionnaire administration prior to and after the intervention.
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보조 연구
Receive patient activation intervention by educational video and brochure
다른 이름들:
Receive patient activation intervention by educational video
다른 이름들:
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실험적: Arm II education and patient activation intervention
Educational intervention administered: Patients receive patient activation intervention comprising CRC and CRC screening information and communication skills training intervention by educational video and brochure, and they also receive a brochure focused on healthy hints to prevent CRC.
Questionnaire administration prior to and after the intervention.
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보조 연구
Receive patient activation intervention by educational video and brochure
다른 이름들:
Receive patient activation intervention by educational video
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Completion rate of CRC screening
기간: Up to 2 months
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A test of two proportions will be used.
If the two groups are different at baseline with respect to key covariates, then a logistic regression model will be used to assess the effect of the intervention on CRC screening controlling for possible confounding variables.
The variables that differ between the two groups will be tested as confounders using risk-factor modeling.
Summary statistics will be used to describe the time point that subjects receive CRC screening, either after the medical visit or after telephone barriers counseling, and relevant comparisons made.
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Up to 2 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mira Katz, Ohio State University Comprehensive Cancer Center
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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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