이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Preventing Aggression in Veterans With Dementia (PAVeD)

2016년 5월 19일 업데이트: VA Office of Research and Development
This study tests whether education about memory and pain might help to prevent aggression in persons with dementia who have pain. The overall goal of this intervention is to reduce the risk of aggressive behavior by improving several areas of patient life that are known causes of aggression: pain, depression, lack of pleasurable activities, caregiver stress and difficulty in caregiver-patient communication.

연구 개요

상세 설명

Dementia is known primarily for its effects on memory, however, eighty percent of persons with dementia also have behavioral disturbances. This is often not addressed, leading to increased use of nursing homes, higher incidence of injury (both patient and caregiver) and the use of tranquilizing medications. Pain is one of the strongest predictors of aggression. The prevalence of pain in persons with dementia is known to be about 50%. Untreated pain is associated with significant negative outcomes, including increased health care use, inactivity and isolation. The investigators aim to determine whether outcome differences exist between active intervention and control conditions in relation to the occurrence of aggressive behavior, pain and depression, and its impact on pleasant activities, caregiver burden, quality of caregiver-patient relationship, antipsychotic use, health-service use, injuries to patient and caregiver, and nursing home placement. The active intervention, Preventing Aggression in Veterans with Dementia (PAVeD), is a family caregiver-focused, home-based intervention that uses psychoeducational and behavioral approaches to help reduce the risk of aggressive behavior in persons with dementia. The objective of PAVeD is to improve several areas of patient life that are known causes of aggression: pain and distress (including mood problems), lack of pleasurable activities, and difficulty in patient-caregiver communication that may negatively affect relationship quality and caregivers' recognition of pain.

연구 유형

중재적

등록 (실제)

203

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Texas
      • Houston, Texas, 미국, 77030
        • Michael E. DeBakey VA Medical Center, Houston, TX

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

60년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

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

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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.
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

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
Patient-reported Worst Pain.
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
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.
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

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

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
Caregiver Burden
기간: Baseline, 3, 6, 12 months

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
Caregiver-perceived Mutuality
기간: Baseline, 3, 6, 12 months

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

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Mark E. Kunik, MD MPH, Michael E. DeBakey VA Medical Center, Houston, TX

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

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

2011년 5월 1일

기본 완료 (실제)

2015년 2월 1일

연구 완료 (실제)

2015년 9월 1일

연구 등록 날짜

최초 제출

2011년 3월 28일

QC 기준을 충족하는 최초 제출

2011년 3월 29일

처음 게시됨 (추정)

2011년 3월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 6월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 5월 19일

마지막으로 확인됨

2016년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • IIR 09-351

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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

3
구독하다