- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00314197
Improving Health Behaviors Through Telephone Linked Care
Study That Examines Integration of the Telephone Linked Care Behavioral Change (Automated Counseling) System Into Primary Care
The investigators propose to conduct a randomized controlled trial at the patient level of the Telephone Linked Care - Behavioral Change (TLC-BC) system, which is designed to promote smoking cessation, reduce risky drinking, and improve physical activity and diet. They expect to:
- successfully integrate an automated telephone behavior change intervention into primary care practices;
- demonstrate improvement in health behaviors for individuals randomized (assigned by systematic chance) to use the TLC-BC system compared to individuals who receive written health education informational packets; and
- evaluate the direct costs associated with the use and operation of the TLC-BC system.
Project aims and hypotheses follow:
Aim 1: Integrate a proven, totally automated computer telephone intervention, Telephone Linked Care - Behavior Change (TLC-BC), into primary care practices. This will be assessed by the patient and clinician/staff surveys at the end of data collection.
Aim 2: Demonstrate an improvement in health behaviors for individuals randomized to use the TLC-BC system compared to individuals who receive written informational packets.
Aim 3: Evaluate the direct costs associated with the use and operation of the TLC-BC system within the primary care setting.
Hypothesis 1: The Telephone Linked Care - Behavioral Change system will be successfully implemented by patients and practices.
Hypothesis 2: At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity, and smoking in the intervention group compared to patients in the control group.
Hypothesis 3: At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kansas
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Leawood, Kansas, 미국, 66211-2672
- American Academy of Family Physicians National Research Network
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years or older
- Capable of giving informed consent
- Reliable access to a phone
- Able to read English
Exclusion Criteria:
- Less than 18 years of age
- Not capable of giving informed consent
- No reliable access to a phone
- Unable to read English (including blindness)
- Too ill to participate
- Not willing to allow the Telephone Linked Care - Behavior Change system to provide health information reports based on responses to physician
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity and smoking in the intervention group compared to patients in the control group
기간: 6 months
|
6 months
|
|
At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
기간: baseline, 3, 6, and 9 months
|
baseline, 3, 6, and 9 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Wilson D Pace, MD, FAAFP, American Academy of Family Physicians National Research Network
연구 기록 날짜
연구 주요 날짜
연구 시작
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 06-005
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