Comprehensive Cognitive Remediation as a Strategy to Prevent Cognitive Impairment Associated With Age and Disability in the Elderly With the REHACOP Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change from baseline to post-treatment and follow-up on one final neurocognition composite score after receiving cognitive remediation.
研究概览
简要总结
The aim of the study was to analyze the effectiveness of a comprehensive cognitive remediation program (REHACOP) in the non demented elderly, obtaining improvements in cognition and functional skills. It was a longitudinal randomized controlled trial with three assessments: basal, post-treatment, and 12-month follow-up.
Recruitment and enrollment were conducted between September 2012 and November 2016. All participants underwent a clinical interview and an extensive neuropsychological battery. Patients were randomized in an experimental and a control group. The groups were formed by a maximum of eight participants run by an experienced therapist. The experimental group received cognitive remediation for 3 months, 3 times per week, 60 minutes per session. The control group consisted of occupational group activities (reading the newspaper, drawing, singing or doing crafts) with the same frequency as the experimental group. Post-treatment assessment was carried out within the first week after completing the intervention. Finally, longitudinal follow-up at 12 months with neuropsychological assessments will be performed.
Objective: To examine the efficacy of a comprehensive cognitive training program (REHACOP) to improve cognition, clinical symptoms and functional disability for the elderly.
详细描述
- Neuropsychological assessment
Premorbid IQ was tested by the following tests:
- Accentuation Reading Test (TAP). This test estimates the premorbid IQ in Spanish speakers through 30 words without accentuation which must be read considering its accentuation. Maximum score of 30 points with higher scores indicating better performance.
- Readers assessment processes (PROLEC) (Pseudoword reading). Evaluates the reading ability and the processes that in it intervene. It consists of 40 pseudowords that must be read correctly as quickly as possible. The scores range from 0 to 40. Higher scores indicate better performance.
- Cognitive Reserve Questionnaire (CRQ). This questionnaire consists of fifteen items that measure the cognitive reserve and includes questions about education/culture, working activity, leisure and hobbies, physical activities and social activities. Maximum score of 26 points with higher scores indicating greater cognitive reserve.
Cognitive status was tested by the following tests:
- Mini Mental State Examination (MMSE) determine cognitive status in five categories (orientation, registration, attention and calculation, recall and language). Maximum score of 30 points with higher scores indicating greater performance.
- Montreal Cognitive Assessment (MOCA)* determine cognitive status in nine categories (visuospatial, executive functioning, naming, memory, attention, language, abstraction, delayed recall and orientation). Maximum score of 30 points with higher scores indicating greater performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age over 55 years
- •signing informed consent
- •independence in daily living activities
排除标准
- •history of neurological or psychiatric conditions, Neuropsychiatric Inventory Cummings > 4
- •Mini Mental State Examination < 20
- •severe physical constraints.
研究组 & 干预措施
Cognitive Remediation Program (REHACOP)
The cognitive rehabilitation program (REHACOP) is a 5 month intervention that allows both individual and group intervention. For the purpose of this study, we included intervention in several domains: attention, language, memory, processing speed, and executive functioning for 3 months, 3 times per week, in 60 minute per session.
干预措施: Cognitive Remediation Program (REHACOP) (Behavioral)
Occupational Therapy
The control group performed of occupational group activities (memory tasks, reading the newspaper, drawing, singing or doing crafts). These activities were accomplished in a group format and with the same frequency as the implementation of REHACOP in the experimental group.
干预措施: Occupational Therapy (Other)
结局指标
主要结局
Change from baseline to post-treatment and follow-up on one final neurocognition composite score after receiving cognitive remediation.
时间窗: 3 months and 12 months follow-up
The neurocognition composite score is one z score that was based on the following test: BTA total score, total score of the forward digits and backward digit of the WAIS-III, total number of words beginning with the letter "p" in 3-minute and total number of words for animals and supermarket categories in 1-minute of the CIFA, total score of learning and total score of long-term recall of the HVLT-R, total score of learning and long-term recall of the BVMT-R, total score of the free drawing of the CDT, total score of letters and total score of the cube analysis of the VOSP, time of the TMT-A, total score of the SPCT, and total score of the word-color trial of the Stroop Test. All raw scores were converted to z-scores. TMT-A score was adjusted so that higher scores indicated better performance. The z-scores were pooled into one composite score with the average of the primary measures mentioned above. Higher scores in this composite score indicated better performance.
次要结局
- Change from baseline score to post-treatment and follow-up on Geriatric Depression Scale (GDS)(3 months and 12 month follow-up)
- Change from baseline score to post-treatment and follow-up on Satisfaction With Life Scale (SWLS)(3 months and 12 months follow-up)
- Change from baseline score to post-treatment and follow-up on Neuropsychiatric Inventory Questionnaire (NPI-Q)(3 months and 12 months follow-up)
- Change from baseline score to post-treatment and follow-up on Lille Apathy Rating Scale (LARS)(3 months and 12 months follow-up)
- Change from baseline score to post-treatment and follow-up on Multidimensional Fatigue Inventory (MFI)(3 months and 12 months follow-up)
- Change from baseline score to post-treatment and follow-up on Subjective Questionnaire on Cognitive and Functional Difficulties of the patient and caregivers(3 months and 12 months follow-up)