- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01325714
Preventing Aggression in Veterans With Dementia (PAVeD)
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients will be eligible to participate in the study if they meet the following criteria:
- have a documented diagnosis of dementia
- receive primary care from the VA
- reside outside a long-term care facility
- live within 45 minutes of the MEDVAMC
- have mild-to-moderate dementia
- have no history of aggression in the past year
- have no evidence of aggression on the CMAI at baseline (i.e., do not score 2 or higher on both frequency and disruptiveness for any of 13 behaviors listed).
have a caregiver who is directly involved with the patient:
- at least 8 hours per week
- sees the patient at least twice a week
- and speaks English
- report clinically significant pain (either directly or through the caregiver as a proxy)
Exclusion Criteria:
Patients will be excluded if they have had history of aggression in the past year
- The investigators will administer the aggression subscale of the Cohen-Mansfield Agitation Inventory (CMAI)
Aggression will be considered present if any of the following items are endorsed as having occurred over the prior year:
- spitting
- cursing/verbal aggression
- hitting
- kicking
- grabbing
- pushing
- throwing
- biting
- scratching
- hurting self/others
- tearing things/destroying property
- making inappropriate verbal sexual advances
- or making inappropriate physical sexual advances
Participants that scored 2 or higher for both frequency and disruptiveness on any of the 13 behaviors listed on the CMAI at baseline were considered aggressive and were excluded from the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Arm 1: PAVeD Intervention
In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems.
The person with dementia will also be able to learn from these visits.
These visits will take place over three months.
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In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems.
The person with dementia will also be able to learn from these visits.
These visits will take place over three months.
|
활성 비교기: Arm 2: Enhanced Usual Care
In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
|
In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
기간: Three Months, Six Months, Twelve Months Post Intervention
|
The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred "less than once a week" or more often) and disruptiveness (i.e., it was "a little" disruptive or more), he/she was considered aggressive. Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors. One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors. One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors. |
Three Months, Six Months, Twelve Months Post Intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Caregiver-Reported Worst Pain
기간: Baseline, 3 months, 6 months, and 12 months
|
This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity |
Baseline, 3 months, 6 months, and 12 months
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Patient-reported Worst Pain.
기간: Baseline, 3, 6, and 12 months
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This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. |
Baseline, 3, 6, and 12 months
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Caregiver Reported Overall Pain Over the Last Several Weeks
기간: Baseline, 3, 6, and 12 months.
|
This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. |
Baseline, 3, 6, and 12 months.
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Patient-reported Overall Pain Over the Last Several Weeks
기간: Baseline, 3, 6, and 12 months
|
This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. |
Baseline, 3, 6, and 12 months
|
Depression
기간: Baseline, 3, 6, and 12 months
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Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item. Total GDS scores range from 0 to 30, with greater scores indicating greater depression. |
Baseline, 3, 6, and 12 months
|
Pleasant Events - Short Form - Alzheimer's Disease
기간: Baseline, 0, 3, 6, 12 months
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The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease. For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no). For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together. The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events. |
Baseline, 0, 3, 6, 12 months
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Caregiver Burden
기간: Baseline, 3, 6, 12 months
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Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always. Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden. |
Baseline, 3, 6, 12 months
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Caregiver-perceived Mutuality
기간: Baseline, 3, 6, 12 months
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Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale. Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal. responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality. |
Baseline, 3, 6, 12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mark E. Kunik, MD MPH, Michael E. DeBakey VA Medical Center, Houston, TX
간행물 및 유용한 링크
일반 간행물
- Fowler JH, Dannecker K, Stanley M, Wilson N, Snow AL, Kunik ME. Preventing aggression and other secondary features of dementia in elderly persons: Three case studies. Bull Menninger Clin. 2015 Spring;79(2):95-115. doi: 10.1521/bumc.2015.79.2.95.
- Bradford A, Shrestha S, Snow AL, Stanley MA, Wilson N, Hersch G, Kunik ME. Managing pain to prevent aggression in people with dementia: a nonpharmacologic intervention. Am J Alzheimers Dis Other Demen. 2012 Feb;27(1):41-7. doi: 10.1177/1533317512439795.
- Breland JY, Barrera TL, Snow AL, Sansgiry S, Stanley MA, Wilson N, Amspoker AB, Kunik ME. Correlates of pain intensity in community-dwelling individuals with mild to moderate dementia. Am J Alzheimers Dis Other Demen. 2015 May;30(3):320-5. doi: 10.1177/1533317514545827. Epub 2014 Aug 7.
- Li J, Snow AL, Wilson N, Stanley MA, Morgan RO, Sansgiry S, Kunik ME. The Quality of Pain Treatment in Community-Dwelling Persons with Dementia. Dement Geriatr Cogn Dis Extra. 2015 Dec 5;5(3):459-70. doi: 10.1159/000441717. eCollection 2015 Sep-Dec.
- Amspoker AB, Snow AL, Renn BN, Block P, Pickens S, Morgan RO, Kunik ME. Patient Versus Informal Caregiver Proxy Reports of Pain Interference in Persons With Dementia. J Appl Gerontol. 2021 Apr;40(4):414-422. doi: 10.1177/0733464820902632. Epub 2020 Feb 6.
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
PAVeD Intervention에 대한 임상 시험
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Michael E. DeBakey VA Medical CenterSouth Central VA Mental Illness Research, Education & Clinical Center알려지지 않은
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VA Office of Research and Development모집하지 않고 적극적으로
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Washington University School of MedicineSt. Jude Children's Research Hospital완전한
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University of MichiganNational Institute on Drug Abuse (NIDA)모집하지 않고 적극적으로
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RTI InternationalUniversity of North Carolina, Chapel Hill초대로 등록결절성 경화증 | 다운 증후군 | 뒤시엔 근이영양증 | 프래더-윌리 증후군 | 취약 X 증후군 | 레트 증후군 | 터너 증후군 | 윌리엄스 증후군 | 엔젤만 증후군 | 염색체 22q11.2 결실 증후군 | 클라인펠터 증후군 | 펠란-맥더미드 증후군 | Dup15Q 증후군 | 스미스 마제니스 증후군미국
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University of MichiganNational Institute of Nursing Research (NINR)완전한