- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01566214
Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease (VHPI)
2018년 6월 12일 업데이트: VA Office of Research and Development
Representational Telehealth Nursing Intervention for Veterans With CHD
The purpose of this research study is to survey patients to learn about their beliefs and behaviors related to the management of heart disease and to discuss options for making healthy lifestyle changes.
From the information the investigators get from patients, the investigators hope to develop better methods for taking care of patients who have heart disease.
연구 개요
상세 설명
Coronary heart disease (CHD) is a significant health threat among veterans.
Compared to their civilian counterparts, veterans experience greater disability, reinfarction, and mortality following myocardial infarction (MI) and other acute coronary syndromes (ACS).
High rates of hypertension, diabetes, and cardiac risk behaviors (e.g., smoking) and low socioeconomic status (SES) further increase veterans' CHD-related morbidity and mortality.
The proposed pilot project will establish the feasibility of a telehealth nursing intervention for veterans with CHD who are recovering from MI/ACS.
The Veterans Heart Attack Representations Telehealth (Vet-HART) intervention is designed to promote adaptive conceptual change in veterans' beliefs (common sense models or representations) about CHD etiology and self-management and facilitate health behavior changes (e.g., smoking cessation, medication adherence, diet management, and increased physical activity).
The long-term goal of this research program is to improve veterans' quality of life (QoL) and reduce their CHD-related morbidity/mortality.
The proposed project is the requisite next step in attaining that goal.
연구 유형
중재적
등록 (실제)
12
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Iowa
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Iowa City, Iowa, 미국, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Admission to an inpatient medicine unit for MI, ACS, and coronary angiography
- Age
Exclusion Criteria:
- Altered mental status
- Language barriers
- Dementia or Cognitive Impairment
- Diagnostic Study
- Resident in long-term care facility prior to the present admission
- Planned discharge to a skilled or intermediate care facility or hospice
- Lack of access to a functioning phone
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Motivational Interview
For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention.
The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
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For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention.
The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
|
간섭 없음: Usual Care
For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
SF-36v Physical Function Scale
기간: Change from baseline to 3-months post hospital discharge
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Physical Functioning Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Role Limitations Due to Physical Health Scale
기간: Change from baseline to 3-months post hospital discharge
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Role Limitations Due to Physical Health Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Role Limitations Due to Emotional Problems Scale
기간: Change from baseline to 3-months post hospital discharge
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Role Limitations Due to Emotional Problems Scale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Energy-Fatigue Scale
기간: Change from baseline to 3-months post hospital discharge
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Energy-Fatigue Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Emotional Well-Being Scale
기간: Change from baseline to 3-months post hospital discharge
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Emotional Well-Being Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Social Functioning Scale
기간: Change from baseline to 3-months post hospital discharge
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Social Functioning Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Pain Scale
기간: Change from baseline to 3-months post hospital discharge
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Pain Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v General Health Scale
기간: Change from baseline to 3-months post hospital discharge
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General Health Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Seattle Angina Questionnaire Physical Limitations Scale
기간: Change from baseline to 3-months post hospital discharge
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Physical Limitations Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Seattle Angina Questionnaire Angina Stability Scale
기간: Change from baseline to 3-months post hospital discharge
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Angina Stability Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Seattle Angina Questionnaire Angina Frequency Scale
기간: Change from baseline to 3-months post hospital discharge
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Angina Frequency Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Seattle Angina Questionnaire Treatment Satisfaction Scale
기간: Change from baseline to 3-months post hospital discharge
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Treatment Satisfaction Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Seattle Angina Questionnaire Disease Perception Scale
기간: Change from baseline to 3-months post hospital discharge
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Disease Perception Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mark W Vander Weg, PhD MS BA, Iowa City VA Health Care System, Iowa City, IA
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2012년 4월 30일
기본 완료 (실제)
2012년 6월 30일
연구 완료 (실제)
2012년 10월 31일
연구 등록 날짜
최초 제출
2012년 3월 19일
QC 기준을 충족하는 최초 제출
2012년 3월 26일
처음 게시됨 (추정)
2012년 3월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 12월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 6월 12일
마지막으로 확인됨
2018년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PPO 09-283
- 200910778 (기타 식별자: University of Iowa)
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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Norwegian Institute of Public HealthStatistics Norway; Society of Interventional Oncology완전한
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University of Zurich완전한외상 후 스트레스 장애(PTSD) | 복합 외상 후 스트레스 장애(CPTSD)스위스
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Northwell HealthNational Institute on Alcohol Abuse and Alcoholism (NIAAA)완전한
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