- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00843505
농촌 1차 의료 관행에서 원격 의료 금연 프로그램 평가
농촌 일차진료의 금연을 위한 원격진료
연구 개요
상세 설명
농촌 지역에 사는 사람들은 도시와 교외 지역에 사는 사람들보다 담배를 피울 가능성이 더 높습니다. 그러나 많은 금연 리소스 및 프로그램은 농촌 지역 거주자에게 제공되지 않을 수 있습니다. 무료 담배 금연 전화는 금연에 도움이 되는 것으로 입증되었으며 미국에 거주하는 거의 모든 사람이 이용할 수 있지만 실제로 흡연자의 1~5%만 사용합니다. 사람들이 금연하도록 돕는 또 다른 옵션은 의사가 사무실이나 진료소에서 금연 프로그램을 제공하도록 하는 것입니다. 그러나 대부분의 진료소에는 이러한 유형의 서비스를 제공할 자원이 없습니다. 원격의료는 웹캠이나 화상회의 장비 등 다양한 기술을 이용하여 전화나 인터넷을 통해 의료정보를 제공한다. 정신과 치료 및 중독 상담을 제공하는 데 성공적으로 사용되었지만 원격 의료 금연 프로그램의 효과를 조사한 연구는 없습니다. 이 연구의 목적은 의사 사무실에서 이루어지는 원격 의료 금연 프로그램의 효과와 시골 흡연자들 사이에서 전통적인 전화 금연 프로그램의 효과를 비교하는 것입니다.
이 연구는 Kansas에 있는 25개의 시골 의사 사무실에서 수행될 것입니다. 참가자는 전화 금연 프로그램 또는 원격 진료 프로그램에 무작위로 배정됩니다. 전화 금연 프로그램 참가자는 8주 동안 금연 상담원으로부터 전화 금연 상담을 4회 받게 됩니다. 원격의료 프로그램 참가자는 8주 동안 금연 상담원으로부터 4회에 걸쳐 원격의료 상담을 받게 되며, 이는 진료실에 있는 컴퓨터의 양방향 웹캠을 통해 전달됩니다. 모든 참가자는 금연 약물에 대한 정보를 포함하여 교육 유인물과 개별 맞춤형 금연 계획을 받게 됩니다. 기준선과 3, 6, 12개월에 모든 참가자는 연구 연구원과의 전화 인터뷰에 참여하여 흡연 습관을 평가합니다. 기준선과 12개월에 참가자는 신체의 니코틴 수준을 결정하기 위해 연구원에게 타액 샘플을 우편으로 보냅니다.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
포함 기준:
- 매일 담배를 피운다
- 하루에 5개비 이상의 담배를 피운다
- 연구 시작 전 최소 1년 동안 담배를 피웠음
- 집 주소와 전화번호가 있습니다
- 전화 평가에 참여할 의사가 있음
- 두 연구 프로그램 중 하나에 배정될 의향이 있음
제외 기준:
- 임신 또는 모유 수유
- 다른 가족 구성원이 연구에 등록했습니다.
- 유학 입국 후 14개월 이내에 거주지에서 이사하는 경우
- 주치의가 연구에 참여하지 않음
- 궐련 이외의 다른 형태의 담배 제품(예: 시가, 침, 코담배) 사용
- 금연 약물 사용
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1
참가자는 원격 의료 금연 프로그램에 참여하게 됩니다.
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참가자는 8주 동안 4회의 원격 의료 금연 상담을 받게 됩니다.
원격 진료 세션은 진료실의 데스크탑 컴퓨터에 장착된 양방향 웹캠을 통해 제공됩니다.
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활성 비교기: 2
참가자는 전화 금연 프로그램에 참여하게 됩니다.
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참가자는 8주 동안 가정에서 전화로 4회에 걸쳐 금연 상담을 받게 됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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7일 포인트 유행 금욕
기간: 3, 6, 12개월에 측정
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3, 6, 12개월에 측정
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2차 결과 측정
결과 측정 |
기간 |
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장기간의 금욕
기간: 3, 6, 12개월에 측정
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3, 6, 12개월에 측정
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kimber P. Richter, PhD, MPH, MA, University of Kansas
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