Indiana University Center for Aging Research, 410 West 10th Street, Indianapolis, IN 46202-3012, USA.
Trials. 2012 Jun 27;13:92. doi: 10.1186/1745-6215-13-92.
Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer's disease reduces patients' neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects' functional decline.
Parallel randomized controlled clinical trial with 1:1 allocation.
A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer's disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA.
All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study.
To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer's disease compared to subjects treated in the control group.
The primary outcome is the Alzheimer's Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects' physical performance scales are completed in the subject's home.
Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio.
Single blinded. Research assistants completing the outcome assessments were blinded to the subjects' treatment group.
Ongoing CLINICALTRIAL.GOV IDENTIFIER: NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011.
鉴于目前尚无疾病修正疗法，探索针对老年痴呆症患者的新纵向护理模式至关重要，该模式应注重提高生活质量和延缓功能下降。在先前的临床试验中，我们发现针对阿尔茨海默病的协作式护理可减少患者的神经精神症状和护理人员的压力。然而，这些生活质量的改善与患者的功能下降延迟无关。
平行随机对照临床试验，1:1 分配。
共有 180 名居住在社区的年龄≥45 岁的患者被诊断为可能或很可能患有阿尔茨海默病；这些患者还必须有一位愿意参与研究的护理人员，并愿意接受家访。参与者及其护理人员均来自为美国印第安纳州印第安纳波利斯市服务的城市公共卫生系统的初级保健和老年医学实践。
所有患者均接受最佳的初级保健，包括在两年内由一名痴呆症护理经理提供协作式护理；这种最佳的初级保健方案代表了我们在城市公共卫生系统中先前的协作式护理干预措施的当地适应性和实施。干预组患者还接受了 24 次家庭作业疗法，为期两年，同时接受最佳的初级保健。作业疗法干预的重点是延缓功能下降并帮助患者和护理人员适应功能障碍。家庭会议针对每个患者-护理人员二人组的具体需求和目标进行定制；这些需求预计会在研究过程中发生变化。
确定与接受对照组治疗的患者相比，最佳的初级保健加家庭作业疗法是否会延缓阿尔茨海默病患者的功能下降。
主要结局是阿尔茨海默病合作研究组日常生活活动量表；次要结局测量指标包括两项基于表现的测量，包括简短身体表现电池和简短便携性肌肉减少症测量。护理人员报告量表和患者身体表现量表的结果评估均在患者家中进行。
符合条件的患者-护理人员二人组将按诊所类型分层，使用计算机生成的随机方案以 1:1 的分配比例进行块随机化。
单盲。完成结局评估的研究助理对患者的治疗组不知情。
正在进行中；CLINICALTRIAL.GOV 标识符：NCT01314950；注册完成日期为 2011 年 3 月 10 日；首位患者随机分组日期为 2011 年 3 月 9 日。
