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临床试验/NCT01165463
NCT01165463已完成不适用

RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults

Fredric D Wolinsky2 个研究点 分布在 1 个国家目标入组 681 人开始时间: 2009年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
681
试验地点
2
主要终点
Useful Field of View Test

研究概览

简要总结

This is second-generation study based on results from ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly). This four-arm study is known as IHAMS (the Iowa Healthy and Active Minds Study). The investigators will formally test from an intent-to-treat perspective for differences on the primary and secondary outcomes based on whether participants were randomized to the basic on-site speed of processing training (SOPT) group (G1), to the on-site basic SOPT plus subsequent booster-training group (G2), to the basic at-home SOPT group (G3), or to the basic attention-control group (G4). Basic training involves 10 hours of either the SOPT or attention-control training during the first 6 weeks of participation. Booster-training involves 4 additional hours of SOPT training at 11 months of participation.

详细描述

In this study, our specific aims are to conduct a randomized controlled trial (RCT) with one-year follow-up that can be fully completed within the NIH Challenge Grant two-year period. The goal of the RCT is to improve cognitive performance among older adults to enhance their quality of life now and into the future. We will randomize 600 participants to four treatment arms separately within two age strata (50-64, and 65 and older).

The four groups include: G1, basic on-site SOPT; G2, on-site basic SOPT plus subsequent booster-training group; G3, basic at-home SOPT; or G4, basic attention-control group. Basic training involves 10 hours of either the SOPT or attention-control training during the first 6 weeks of participation. Booster-training involves 4 additional hours of SOPT training at 11 months of participation.

Our primary outcome measure is speed of processing, and we will use several reliable and valid instruments to provide a multidimensional assessment, including the Useful Field of View Test, the Symbol Digit Modalities Test, the Trail Making Test, the Controlled Oral Word Association Test, the Digit Vigilance Test, and the Stroop Color and Word Test.

There are seven key hypotheses (Hn). H1 involves a replication of ACTIVE (i.e., on-site SOPT delivery, with or without booster-training) in which groups G1 and G2 are combined vs. the attention control group and hypothesizes statistically significant evidence to support the benefit of being assigned to on-site training vs. the attention control group.

H2 and H3 are designed to separate the basic training effect (H2) from the basic plus booster-training effect (H3) among the on-site delivery groups (G1 and G2) vs. the attention control group (G4), and hypothesizes benefits of SOPT training vs. attention control regardless of booster-training.

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 (Investigator)

入排标准

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

入选标准

  • 50 years of age or older
  • Patient of the FCC in Family Medicine or General Internal Medicine Clinic at UIHC
  • No known memory problems

排除标准

  • Significant vision impairments
  • Lack of access to a computer or owns a MAC
  • Lives more than 37 miles from the lab
  • Traumatic Brain Injury or severe stroke

研究组 & 干预措施

Clinic-based SOPT basic training

Experimental

Clinic-based SOPT basic training for 10 hours.

干预措施: SOPT basic training (Behavioral)

Home-based SOPT basic training

Experimental

Home-based SOPT basic training for 10 hours.

干预措施: SOPT basic training (Behavioral)

Crossword Puzzles Training

Active Comparator

Crossword puzzles training for 10 hours in our lab.

干预措施: Crossword Puzzles (Behavioral)

SOPT basic and SOPT booster-training

Experimental

Clinic-based SOPT basic training and SOPT booster training.

干预措施: SOPT basic training (Behavioral)

SOPT basic and SOPT booster-training

Experimental

Clinic-based SOPT basic training and SOPT booster training.

干预措施: SOPT booster training (Behavioral)

结局指标

主要结局

Useful Field of View Test

时间窗: 12 months

The Useful Field of View (UFOV) is a computer-administered test of functional vision and visual attention. UFOV consists of three subtests which assess speed of visual processing under increasingly complex task demands. The examinee must detect, identify, and localize briefly presented targets.

次要结局

  • Controlled Oral Word Association Test(12 Months)
  • Symbol Digit Modalities Test(12 Months)
  • Stroop(12 months)
  • Digit Vigilance Test(12 months)
  • Comprehensive Trail Making Test(12 Months)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fredric D Wolinsky

Professor of Public Health

University of Iowa

研究点 (2)

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