- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00763308
A Web-Based Cardiovascular Intervention for the Workplace
Fast Track Program to Create a Web-Based Cardiovascular Intervention for the Workplace
연구 개요
상세 설명
Heart disease, or cardiovascular disease, refers to a range of diseases including coronary artery disease, heart attack, heart failure, high blood pressure, and stroke. These diseases are all related to problems with the heart and blood vessels, and collectively are the leading cause of death in the United States. Heart attacks or coronary artery disease sometimes have warning signs, but both can occur without warning. Approximately half of all heart attacks are fatal. Forty percent of all deaths in the United States are the result of heart disease.
Certain factors can predict whether people get heart disease. Some of these factors, like biological sex or genes inherited from a person's family, cannot be changed, but many others can. Not smoking, eating well, exercising regularly, and maintaining a healthy weight are some of the things people can do to lower their risk of heart disease. This study will develop and then test an Internet-based program that teaches people about heart health and supports them in changing behaviors that put them at risk for heart disease.
This study will be divided into two phases. In the first phase, researchers will create the Heart Healthy program, show it to focus groups, and try to improve it based on their comments. The goals of the program are to educate users in the fundamentals of heart health and risk factors for heart disease and to provide a system for starting and sustaining lifestyle changes that reduce risk of heart disease. The program will be designed for employee use in a workplace, and a tool kit will be developed for managers to supplement the employee program. The prototype will include modified segments from existing Web-based programs created by a non-profit organization, the ISA Group. The design of the program will be guided by feedback from employees and managers who use it and from experts in cardiology and epidemiology.
In the second phase, the program will be tested in a work site. Employees at risk for heart disease will be recruited and randomly assigned to receive either the Healthy Heart program or treatment as usual. Before and after the intervention, participants will be assessed on knowledge gained, attitudes changed, alterations in health behavior, and reductions in cardiovascular risk. Managers who receive the supplementary program will be tested in knowledge gained and plans for policy or procedural changes. The ultimate goal of this phase is to fully develop the Healthy Heart program for use in industry and health care settings.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
Virginia
-
Alexandria, Virginia, 미국, 22314
- ISA Associates, Inc.
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Works in participating company
- At least one cardiovascular risk factor
Exclusion Criteria:
- No known cardiovascular risks
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 1
Participants will use the Web-based Heart Healthy program.
|
The Heart Healthy program will be developed during the course of the study based on goals set by researchers and based on feedback from focus groups.
The goals of the program are to educate users in the fundamentals of heart health and risk factors for heart disease and to provide a system for starting and sustaining lifestyle changes that reduce risk of heart disease.
|
|
간섭 없음: 2
참가자는 평소와 같이 치료를 받게 됩니다.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in health attitudes and behaviors
기간: Measured pre- and post-intervention
|
Measured pre- and post-intervention
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in cardiovascular risk status
기간: Measured pre- and post-intervention
|
Measured pre- and post-intervention
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Diane K. Deitz, PhD, ISA Associates
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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
- 535
- R44HL087540-01 (미국 NIH 보조금/계약)
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. .