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临床试验/NCT00362284
NCT00362284已完成不适用

Expanded Counseling and Support for Adult Children Caring for Parents With Alzheimer's Disease or Similar Disorders

University of Minnesota3 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
161
试验地点
3
主要终点
caregiver depression

研究概览

简要总结

The purpose of this study is to determine the effectiveness of a comprehensive counseling and support intervention for people who care for parents with Alzheimer's disease (AD) or other dementias on outcomes such as stress, depression and ability to postpone or avoid nursing home placement.

详细描述

Although a range of studies have examined the stress and depression of family caregivers of persons suffering from dementia, the effectiveness of psychosocial interventions to assist caregiving families and their disabled elderly relatives is uncertain. The comprehensive support protocol to be implemented, the Enhanced Counseling and Support (ECS) program, has been successfully implemented at the Silberstein Aging and Dementia Research Center of New York University School of Medicine (NYU-ADRC) over the past 19 years. However, the initial evaluation of the ECS was limited to a single geographic area (New York City proper) and a specific type of dementia caregiver (spouses).

The specific aims of this 4-year project are as follows: 1) Examine whether the ECS can achieve positive outcomes for adult child caregivers. Few psychosocial interventions are directed specifically at adult child caregivers, and evaluating the ECS in adult child caregiving situations, which few studies have done, will further demonstrate the effectiveness of this program and add considerably to the AD caregiver intervention literature; and 2) Determine if the ECS, an intervention of proven efficacy for AD caregivers in a northern U.S. urban community (New York City), will also be effective in alleviating negative outcomes among AD caregivers at a Midwestern project site. The study will ascertain whether the comprehensive support program developed at NYU is generalizable to caregivers from areas other than the New York City area and leads to similar benefits that are maintained over long periods of time (i.e., up to 3.5 years).

In order to accomplish the specific aims of the project, the following study hypotheses have been proposed:

  1. Adult child caregivers in the treatment conditions of the University of Minnesota (UM) and NYU-ADRC will report similar decreases on measures of stress when compared to usual-contact controls;
  2. Adult child caregivers in the intervention conditions at both sites will develop improved social support resources and experience significantly greater decreases of family conflict in a similar manner;
  3. Adult child caregivers in the treatment conditions at UM and NYU-ADRC will report similar decreases on global measures of psychological distress, such as depression. Similarly, treatment caregivers will report greater increases in subjective health than their counterparts in the usual-contact control; and
  4. Membership in the treatment condition of the ECS and its benefits (e.g., increased social support, decreased stress) will lead to delayed institutionalization (e.g., nursing home placement) of care recipients at the UM and NYU-ADC sites.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant (i.e., adult child) must be the 'primary' caregiver of the patient with a diagnosis of dementia (i.e., the first person called if the patient is in need of help) at the time of the baseline interview
  • Must be a daughter, son, daughter-in-law, or son-in-law of the patient
  • Patient must live in the community (i.e., at home, with the caregiver, with other relatives)
  • Sees the individual with dementia once a week or more

排除标准

  • Unable to understand or speak English comfortably
  • Inadequate hearing
  • Unwilling to participate in the study or sign the consent form
  • Suffered from or received treatment for an emotional or psychological disorder, such as depression, anxiety, or some other type of psychotic episode, within the past 6 months
  • Not physically able to participate
  • Received counseling for problems arising as a caregiver

结局指标

主要结局

caregiver depression

时间窗: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible

The Geriatric Depression Scale.

Care recipient nursing home/institutional placement

时间窗: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible

Adult child caregivers self-reported whether the care recipient was admitted to a residential care setting and the date of admission.

Caregiver emotional stress

时间窗: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible

Measures of role captivity, role overload, and general perceived stress.

caregiver social support

时间窗: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible

Three single items that measured perceptions of support received by the adult child caregiver.

次要结局

  • secondary stressors(baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible)
  • Caregiver subjective health(baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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