- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01828567
Will Veterans Engage in Prevention After HRA-guided Shared Decision Making? (ACTIVATE)
연구 개요
상세 설명
Over half of all deaths, and many illnesses, can be attributed to four modifiable risk factors: tobacco use, overweight/obesity, physical inactivity, and alcohol use. There are clear links between these modifiable factors and heart disease, cancer, chronic lung disease, and stroke which continue to be the leading causes of death in the United States. Significant improvements have been made in controlling conditions that lead to heart disease, cancer and stroke (e.g., hypertension and hyperlipidemia). However, the underlying behavioral factors (e.g., obesity, tobacco use, and physical inactivity) have not been addressed as well. Prevention is particularly important for Veterans because of the high prevalence of significant risk factors for poor health. For example, more than 70% of Veterans Health Administration (VHA) patients are overweight (body mass index [BMI] 25kg/m2) and one-third are obese (BMI 30kg/m2), which is significantly higher than the US population. Smoking also remains a significant problem among Veterans, with VHA enrollment data from 2010 indicating a prevalence of 20%. Younger Veterans are at particularly high risk for developing chronic illnesses because they are more likely to be overweight/obese and smoke more heavily than non-Veterans.
The investigators propose a two-site, two-arm randomized trial measuring the effectiveness of a Shared Decision Making (SDM) intervention in activating Veterans to enroll in effective prevention services, and improve cardiovascular risk, compared to Veterans Administration (VA) usual care. The study will be performed at the Durham and Ann Arbor Veterans Administration Medical Centers (VAMCs). Each arm will have 225 patients; patients will be VA users with at least one modifiable risk factor (obese, inactive, or tobacco user) who are not currently enrolled in a prevention service. The SDM intervention will be conducted by a prevention coach, telephone based, and will use the output from VHA's Healthy Living Assessment (HLA) to engage Veterans in a conversation where individual preferences are matched to behaviors, and choices for specific prevention services. The resulting prevention action plan will be shared with the Veterans primary care team, and documented in the medical record.
Outcomes will be obtained at baseline, 1 month and 6 months after enrollment by blinded research personnel. The primary outcomes will be: 1) proportion enrolled in effective prevention services; and 2) change in the Patient Activation Measure (PAM). The secondary outcome is 10-year risk of coronary events, as measured by Framingham Risk Score (FRS). Process evaluations of the intervention and its implementation will also be conducted to inform future dissemination and implementation should it prove effective.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
-
-
North Carolina
-
Durham, North Carolina, 미국, 27705
- Durham VA Medical Center, Durham, NC
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
To be included in the study, patients must meet the following:
- enrolled in primary care at the Durham or Ann Arbor Health Care Systems
- have one modifiable risk factor identified by a healthy living assessment (physical inactivity, overweight or obese by BMI, or tobacco user)
Exclusion Criteria:
Individuals will be excluded if they have any of the following:
- have been hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past three months
- have an active diagnosis of psychosis
- have any other health condition they feel would impede participation in the study
- reside in a nursing home
- are severely impaired in hearing or speech, so that they cannot respond to telephone calls
- have significant cognitive or memory impairment
- do not have access to a telephone
- are participating in another prevention intervention study
- are already enrolled in a formal prevention service
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: 제어
평소 케어
|
|
실험적: Intervention
Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment
|
A series of two phone sessions with a prevention coach.
The first to engage the veteran to choose a preferred prevention program and link them to Patient Aligned Care Team (PACT), and a follow-up call one month later to assess the progress of the prevention plan.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Enrollment in Prevention Services
기간: 1 and 6 months (cumulative)
|
Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.
|
1 and 6 months (cumulative)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Patient Activation Measures (PAM)
기간: Baseline assessment
|
Patient Activation Measures (PAM) assesses patients capacity to manage their health.
Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors.
Minimum score is a zero and maximum is one hundred.
Higher score is better.
The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
|
Baseline assessment
|
Patient Activation Measures
기간: 1 month assessment
|
Patient Activation Measures (PAM) assesses patients capacity to manage their health.
Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors.
Minimum score is a zero and maximum is one hundred.
Higher score is better.
The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
|
1 month assessment
|
Patient Activation Measures
기간: 6 months assessments
|
Patient Activation Measures (PAM) assesses patients capacity to manage their health.
Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors.
Minimum score is a zero and maximum is one hundred.
Higher score is better.
The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
|
6 months assessments
|
Framingham Risk Score
기간: Baseline
|
The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual.
This is not a scale however, lower score indicates less risk.
|
Baseline
|
Framingham Risk Score
기간: 6 months
|
The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual.
This is not a scale however, lower score indicates less risk.
|
6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Laura J. Damschroder, MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI
- 수석 연구원: Eugene Z. Oddone, MD MHSc, Durham VA Medical Center, Durham, NC
간행물 및 유용한 링크
일반 간행물
- Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Aug 13;19:100631. doi: 10.1016/j.conctc.2020.100631. eCollection 2020 Sep.
- Oddone EZ, Damschroder LJ, Gierisch J, Olsen M, Fagerlin A, Sanders L, Sparks J, Turner M, May C, McCant F, Curry D, White-Clark C, Juntilla K. A Coaching by Telephone Intervention for Veterans and Care Team Engagement (ACTIVATE): A study protocol for a Hybrid Type I effectiveness-implementation randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:1-9. doi: 10.1016/j.cct.2017.01.007. Epub 2017 Jan 24.
- Oddone EZ, Gierisch JM, Sanders LL, Fagerlin A, Sparks J, McCant F, May C, Olsen MK, Damschroder LJ. A Coaching by Telephone Intervention on Engaging Patients to Address Modifiable Cardiovascular Risk Factors: a Randomized Controlled Trial. J Gen Intern Med. 2018 Sep;33(9):1487-1494. doi: 10.1007/s11606-018-4398-6. Epub 2018 May 7.
- Sloan C, Stechuchak KM, Olsen MK, Oddone EZ, Damschroder LJ, Maciejewski ML. Short-Term VA Health Care Expenditures Following a Health Risk Assessment and Coaching Trial. J Gen Intern Med. 2020 May;35(5):1452-1457. doi: 10.1007/s11606-019-05455-z. Epub 2020 Jan 2.
- Nouri SS, Damschroder LJ, Olsen MK, Gierisch JM, Fagerlin A, Sanders LL, McCant F, Oddone EZ. Health Coaching Has Differential Effects on Veterans with Limited Health Literacy and Numeracy: a Secondary Analysis of ACTIVATE. J Gen Intern Med. 2019 Apr;34(4):552-558. doi: 10.1007/s11606-019-04861-7. Epub 2019 Feb 12.
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CRE 12-288
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
A de-identified, anonymized dataset will be created and shared. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD.
A local privacy officer and study statistician will certify that the dataset contains no PHI prior to distribution. Data will be provided to requestor in electronic form.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
심장 질환에 대한 임상 시험
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University of... 그리고 다른 협력자들아직 모집하지 않음심부전, 수축기 | 박출률이 감소된 심부전 | 심부전 New York Heart Association Class IV | 심부전 New York Heart Association Class III폴란드
-
Novartis Pharmaceuticals완전한핵심 연구의 12개월 치료 기간을 성공적으로 완료한 환자(de Novo Heart Recipients)는 EC-MPS 치료에 관심이 있었습니다.
-
University of WashingtonAmerican Heart Association완전한심부전,울혈 | 미토콘드리아 변경 | 심부전 New York Heart Association Class IV미국