- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01686490
LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator (AICD) (AICD)
2012년 9월 17일 업데이트: Virginia P. Williams, Ph.D., Williams LifeSkills
LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator
The purpose of this trial was to develop the initial sections of a video/DVD cassette that provided guidance about mastering stressful situations for patients who had been informed that they need an implantable cardioverter-defibrillator (AICD).
We adapted the existing LifeSkills video (which was already been shown effective in patients with heart diseases) to the specific needs of patients with AICD's.
Before its development, we held separate focus groups with healthcare providers of AICD patients, pre-implantation patients, and post-implantation patients.
After the video/accompanying workbook was produced, we held an additional focus group with patients who had received the video/workbook before receiving their AICD.
연구 개요
상태
완전한
상세 설명
Patients who had received the video/workbook told the focus group leader that they wanted more information about their AICD and a clearer presentation about how stress management was related to living with their AICD.
연구 유형
중재적
등록 (실제)
37
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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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
21년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adult patients (age> 21 years old)
- For one of the initial focus groups and for the focus group of patients who had watched the produced modules: Patients who have received a recommendation for an AICD and have agreed to have it in the pre-implantation stage (do not already have the implant)
- For the other initial focus group: patients who already have an AICD.
Exclusion Criteria:
- Patients who are medically unstable [New York Heart Association class IV heart failure, recent (within 30 days) myocardial infarction or admission for unstable angina or worsening heart failure, in-patients, or patients who were admitted less than 1 month before potential enrollment will be excluded].
- Patients who are suffering from other medical illnesses: only the following categories will be exclusionary: Diseases that cause severe cognitive impairment that may lead to inability to understand or follow study procedures (i.e., severe dementia, identified by the patients' inability to repeat the study procedures and by a mini-mental status exam that will be done if dementia is suspected); Diseases that cause severe psychotic symptoms leading to disorientation (i.e., hepatic encephalopathy).
- Patients who are actively suicidal (suspected from the suicide question on the depression questionnaire
- Patients who cannot understand the study procedures due to cognitive or language barriers (provided an effort was made to offer translation).
- The process for dealing with individuals who indicate that they may be suicidal, depressed or anxious will be as follows: Immediately upon receipt of the completed questionnaires at the coordinating office, the Beck Depression Inventory and the Impact of Event Scale will be evaluated. If the responses indicate suicidal ideation the subject will be called and asked to contact his/her primary care provider for an immediate appointment. The primary care provider will be contacted that day to inform him/her of the finding. If the responses to the Impact of Event Scale or the BDI indicate stress or depression, a letter will be sent to the subject recommending that he/she contact the primary care provider. A copy of the letter will be forwarded to the PCP.
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: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: D.
The focus is evaluation of LifeSkills Video/Workbook for patients about to receive an AICD.
Patients who now have received their AICD were given a video/workbook pre-implantation as an intervention to reduce their concerns/distress.
After implantation, they will be asked what was and was not helpful about the materials they received.
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will view the 3 completed sections of the video/workbook
This exploratory intervention first met in a focus group with healthcare professionals and another focus group with patients who already had received an automatic implantable cardiac defibrillator to learn more about what video and accompanying workbook material it would be helpful for patients to receive pre-inplantation.
Another focus group was held with post-implantation patients asking them what additional knowledge would have been helpful.
Three sections of the video with accompanying workbook were then produced and given to pre-inplantation patients.
A focus group was then held with these patients after their procedure to ask them what had and had not proved helpful.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Whether patients understood the contents of the produced sections of the video/workbook and whether these contents were helpful. This will be determined by their comments during a focus group which will be held after they have watched the video.
기간: After AICD patients who watched the video/workbook before implantation have been implanted.
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AICD patients who watched the first three sections of the proposed video with accompanying workbook will be asked in a focus group if they found the information comprehensible and if the information was helpful.
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After AICD patients who watched the video/workbook before implantation have been implanted.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Joseph Gordon Rogers, MD, Duke University, Eed Director, Cardiac Transplant and Mechanical Circulatory Support Program
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
2007년 12월 1일
기본 완료 (실제)
2009년 8월 1일
연구 완료 (실제)
2009년 8월 1일
연구 등록 날짜
최초 제출
2012년 6월 27일
QC 기준을 충족하는 최초 제출
2012년 9월 17일
처음 게시됨 (추정)
2012년 9월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 9월 17일
마지막으로 확인됨
2012년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2924526
- 1R41HL083635-01A2 (미국 NIH 보조금/계약)
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