Behavioral Trial Studying Programmed Training to Improve Advocacy Skills for Individuals With Traumatic Brain Injury (MAP)
2013년 1월 16일 업데이트: Allen Brown, Mayo Clinic
Midwest Advocacy Project: A Community-based Randomized Practical Behavioral Trial of Programmed Advocacy Training for Individuals With Traumatic Brain Injury and Their Significant Others
The Midwest Advocacy Project (MAP) is a community-based multiple-site randomized practical behavioral trial of advocacy skill training for individuals with traumatic brain injury (TBI), their families, and significant others. The purpose is to evaluate the efficacy of a 4-session advocacy training program to improve behavioral advocacy skills compared to self-directed advocacy training of the same session frequency. Groups will be randomly assigned to either a programmed group or a self-directed group in collaboration with the Brain Injury Associations of Minnesota, Iowa, and Wisconsin each year over the 5 year study period. The primary outcome is pre-post measures of written and verbal advocacy skill measured by the Advocacy Behavior Rating Scale.
It is hypothesized that subjects who receive programmed advocacy training will show greater positive change on pre-post measures of advocacy skill measures than subjects receiving self-directed training.
연구 개요
연구 유형
중재적
등록 (실제)
234
단계
- 2 단계
- 3단계
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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Urbandale, Iowa, 미국, 50322
- Brain Injury Association of Iowa
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Minnesota
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Minneapolis, Minnesota, 미국, 55413
- Brain Injury Association of Minnesota
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Wisconsin
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Pewaukee, Wisconsin, 미국, 53072
- Brain Injury Association of Wisconsin
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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:
- 18 years of age or older
- moderate-severe TBI as indicated by one of the following:
- post traumatic amnesia (PTA) > 24 hours
- or loss of consciousness > 30 minutes
- or neuroimaging evidence of trauma-related intracranial abnormality
- Or the family/significant other of an individual with TBI meeting the above criteria
- 1 or more years post-injury
- Functional English speaker
- Signed consent to participate
Exclusion Criteria:
- Severe cognitive impairment as indicated by one or more of the following:
- Disorientation to person or year
- Unable to complete pre-program interview because of severe communication limitations
- Unable to remember important information given in the course of the pre-program interview, such as, time and place of program, number of sessions, and contact person
- Unable to complete the pre-program interview because of loss of emotional control, such as, extended tearfulness, sustained anger, verbal attack on interviewer
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Curriculum
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Day-long presentation of an advocacy training curriculum by the state's Brain Injury Association staff: One session per month for 4 consecutive months.
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활성 비교기: Self-directed
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Day-long group-based self-directed advocacy training activity: One session per month for 4 consecutive months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Score on the Advocacy Behavior Rating Scale
기간: Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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2차 결과 측정
결과 측정 |
기간 |
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Score on Advocacy Activity Scale
기간: The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Score on the Perceived Control Scale for Brain Injury
기간: The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Craig Hospital Inventory of Environmental Factors-Short Form
기간: The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Satisfaction with Life Scale
기간: The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The SF-12
기간: The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Advocacy Activity Scale
기간: Every 6 months after intervention until the end of the 5-year study period
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Every 6 months after intervention until the end of the 5-year study period
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Allen W Brown, MD, Mayo Clinic
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 8월 1일
기본 완료 (실제)
2012년 9월 1일
연구 완료 (실제)
2012년 9월 1일
연구 등록 날짜
최초 제출
2009년 10월 22일
QC 기준을 충족하는 최초 제출
2009년 10월 26일
처음 게시됨 (추정)
2009년 10월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 1월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 1월 16일
마지막으로 확인됨
2013년 1월 1일
추가 정보
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. .