Cognitive Rehabilitation for Older Veterans With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 4
- 主要终点
- Change in Objective Cognitive Performance Composite z Score
研究概览
简要总结
The number of older Veterans with Mild Cognitive Impairment (MCI) seeking care within the Veterans Affairs (VA) health care system is increasing and is expected to increase more rapidly as Vietnam era Veterans age. The cognitive effects of MCI and subsequent neurodegenerative disorders can adversely affect a Veteran's ability to function independently and failure to provide appropriate intervention can result in an increased need for healthcare services and VA benefits in the future. The VA currently spends over $19,000 annually per patient to care for Veterans with dementia (Zhu et al., 2009), and delaying the onset of dementia even by one to two years will result in substantial financial savings to the VA and quality of life gains for the Veteran. Since present pharmacological interventions have demonstrated limited efficacy, alternative treatments are needed. Therefore, an evidence-based cognitive training intervention that optimally addresses the needs of older Veterans with MCI is of critical importance to the VA patient care mission.
详细描述
Due to the aging of the United States population, age-related cognitive problems resulting from Alzheimer's disease and other causes of dementia are increasingly prevalent. Before individuals are diagnosed with dementia, they typically exhibit a period of "mild cognitive impairment" (MCI). Mild cognitive problems associated with MCI frequently impact an individual's ability to perform everyday tasks, including working, independent living, and medication adherence. Veterans are at increased risk of cognitive decline, and the Veterans Healthcare Administration (VA) is now providing health care to surging numbers of older Veterans with MCI who report significant cognitive complaints, difficulties with everyday functioning, and concerns about impending dementia. Despite high patient demand, few cognitive rehabilitation interventions exist that specifically address the needs of older Veterans with MCI that are widely accessible, patient-centered, and evidence-based. To the investigators' knowledge, no randomized controlled trials have been conducted that evaluate the efficacy of manualized, brief and inexpensive, yet comprehensive (multi-modal) cognitive rehabilitation interventions for older Veterans with MCI. Hence, the primary objective of this study is to evaluate the efficacy of Motivationally Enhanced Compensatory Cognitive Training (ME-CCT), a manualized cognitive rehabilitation group treatment for older Veterans with MCI. The study's specific aims are to determine whether ME-CCT is effective for: 1) improving objective cognitive performance and functional capacity, 2) improving subjective cognitive complaints, subjective functioning, and collateral measures of everyday function, and 3) increasing modifiable protective factors (e.g., diet, exercise) associated with reduced risk for MCI. The investigators will also explore mediators and moderators of treatment effects. The overall goal is to evaluate a manualized group treatment for the symptoms of MCI that can be readily implemented in VA treatment settings. The study design makes use of the convergent availability of resources at the two participating VA Healthcare Systems in San Diego, California and Portland, Oregon to conduct a randomized controlled trial of ME-CCT. The study will recruit a sample of 216 Veterans (108 at each site) who meet criteria for MCI. Inclusion criteria will be: 1) Veterans 55 years old or older enrolled at one of the participating VAs who are able to provide informed consent, 2) Independently living, 3) Meet criteria for MCI based on previously published criteria (Petersen, 2004; Petersen, 2011), and 4) Willingness to participate in audio-recorded group sessions. Exclusion criteria will be: 1) Current substance use disorder with less than 30 days abstinence, 2) History of schizophrenia, schizoaffective disorder, or other primary psychotic disorder, 3) History of significant head trauma with loss of consciousness >30 minutes, and 4) Auditory or visual impairments that would prevent ability to participate in the cognitive rehabilitation group. Eligible participants will be randomly assigned to either the ME-CCT or an active control group, Goal-focused Supportive Contact (SC). The SC group will provide the same frequency and amount of therapist and peer contact as ME-CCT, but without specific training in cognitive strategies, lifestyle strategies, or motivational enhancement. 8 2-hour long weekly sessions will be delivered in both conditions. Both groups will undergo evaluations at baseline, 4 weeks (midway through the intervention), 8 weeks (immediately following the end of the intervention), and 21 weeks (3 months after completion of the intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors will be blind to treatment group assignment.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans >55 years old enrolled at one of the participating VA sites (VASDHS and VAPORHCS) who are able to provide informed consent
- •Independently living
- •Meet criteria for MCI based on previously published criteria (see below)
- •Willingness to participate in audio-recorded sessions.
- •MCI Criteria:
- •Concern about a decline in cognitive functioning expressed by a physician, informant, participant or nurse
- •Cognitive impairment in one or more of the following domains
- •executive function
- •attention
- •language or visuospatial abilities
- •Normal or minimal impairment in functional activities
- •Does not meet criteria for dementia
排除标准
- •Current substance use disorder with < 30 days abstinence
- •History of schizophrenia, schizoaffective disorder, or other primary psychotic disorder
- •History of significant brain injury with loss of consciousness > 30 minutes
- •Auditory or visual impairments that would prevent ability to participate in the cognitive rehabilitation group or benefit from compensatory strategies
结局指标
主要结局
Change in Objective Cognitive Performance Composite z Score
时间窗: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in composite z score on the following tests: Hopkins Verbal Learning Test-Revised (HVLT-R) Brief Visuospatial Memory Test-Revised (BVMT-R) Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span WAIS-IV Coding Delis-Kaplan Executive Function System (D-KEFS) Trails, Number and Letter Sequencing D-KEFS Trails, Number-Letter Switching D-KEFS Color-Word Interference Test, Inhibition and Inhibition-Switching A Z score of 0 represents the sample mean. Higher composite Z scores reflect better performance.
Change in Functional Capacity Performance Composite z Score
时间窗: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.
Change in composite z score on the following measures: UCSD Performance-Based Skills Assessment-Brief (UPSA-B) Medication Management Ability Assessment (MMAA) Neuropsychological Assessment Battery Daily Living Memory Neuropsychological Assessment Battery Judgment Neuropsychological Assessment Battery Driving Scenes A Z score of 0 represents the sample mean. Higher Z scores reflect better performance.
次要结局
- Change in Subjective Everyday Functioning Composite Score(assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.)
- Change in Everyday Cognition Scale(assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.)
- Change in Cognitive Activity Inventory(assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.)
- Change in CHAMPS Physical Activity Questionnaire for Older Adults(assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.)
- Change in Portland Cognitive Strategies Scale(assessed at baseline, 4 weeks, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.)
- Change in Fitbit-measured Physical Activity Level(assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported.)
- Change in Fitbit-measured Sleep Time(assessed at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 21 weeks; change from baseline to 21 weeks reported.)