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临床试验/NCT06645652
NCT06645652进行中(未招募)不适用

Feasibility and Preliminary Effects of a Drawing-based Intervention on Cognition and Wellbeing of Community-Dwelling Adults at Risk for ADRD

Northeastern University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Change in Drawing skills

研究概览

简要总结

The present study investigates the feasibility, acceptability, and preliminary effects of a novel visual arts-based intervention in an older adult population. In a randomized controlled design, two arts-based interventions will be evaluated with a group of 40 participants.

详细描述

A two-arm randomized controlled study will be conducted to obtain within-group ratings of feasibility and acceptability, as well as between-group differences in drawing skills after training. In the drawing intervention, participants will learn and train drawing skills through exercises that target attention, perception, and visuospatial reasoning. In the active control condition, participants will navigate virtual art galleries. Both interventions will be completed remotely and at home. Participants will complete in-lab assessment sessions before and after the training.

Each intervention consists of 6 weeks of training for up to 2 hours a week, including up to 1 hour of a self-guided lesson and prompted daily drawing practice adding up to 1 hour in the drawing intervention and 2 1-hour sessions of virtual gallery exploring per week in the arts appreciation intervention. The pre-test is administered within one week of the start of training and the post-test is administered within one week of training completion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •55-85 years of age
  • •Able to understand and speak English and follow study procedures
  • •Does not have a psychological or neurological condition that would prevent from being able to give consent to participate

排除标准

  • •Formal diagnosis of dementia or other neurological disease, including Mild Cognitive Impairment
  • •Abnormal visual acuity prohibitive of tablet-based training
  • •Physical handicap (motor or perceptual) that would impede training procedures
  • •Medical illness requiring treatment and/or significant absences during the study timeline

研究组 & 干预措施

Participatory Arts

Experimental

Participants will develop drawing skills through learning specific techniques and deliberately engaging cognitive domains such as perception, visuospatial reasoning, attention, and processing speed. The intervention is completed in a hybrid format where lessons are completed online and practice is completed in a sketchbook and drawing things from life. Prompts are provided to guide daily practice sessions. Techniques learned include contour drawing, gesture drawing, negative space drawing.

干预措施: Training in observational drawing (Behavioral)

Receptive Arts

Active Comparator

Participants will learn about different art periods and browse online galleries. The materials will be available online through a website through which participants will access and browse online galleries. Weekly topics include genres, subjects, or specific mediums. Prompts and vocabulary will accompany the galleries to guide their learning.

干预措施: Arts engagement through digital galleries (Behavioral)

结局指标

主要结局

Change in Drawing skills

时间窗: Pre-test (baseline) and post-test 6-8 weeks later

Participants will have 7 minutes to draw a still life from observation. Accuracy is scored using a rubric assessing accuracy on global and local features.

Acceptability - Age appropriateness

时间窗: Throughout training (weeks 1-6 of training)

Perceived age-appropriateness of the course content, likert scale 0-5

Acceptability - engagement

时间窗: Throughout training (weeks 1-6 of training)

Level of engagement with the course materials, likert scale 0-5

Acceptability - Welcoming

时间窗: Throughout training (weeks 1-6 of training)

How welcoming participants perceived the activities, likert scale from 0-5

Feasibility - completion rate

时间窗: At the post-test 6-8 weeks later

% of participants who completed both testing sessions

Feasibility - adherence

时间窗: At the post-test 6-8 weeks later or when a participant decided to drop out

Number of lessons that participants completed, from 0-6

Feasibility - Frequency

时间窗: Throughout training (weeks 1-6 of training)

Total number of times participants logged their progress

Feasibility - Attrition

时间窗: At the post-test 6-8 weeks later or when a participant decided to drop out

List of common reasons for drop-out and the number of times a reason was mentioned

次要结局

  • Change in Perception - contour integration(Pre-test (baseline) and post-test 6-8 weeks later)
  • Change in Perception - visual disembedding(Pre-test (baseline) and post-test 6-8 weeks later)
  • Change in Visuospatial Reasoning - construction and memory(Pre-test (baseline) and post-test 6-8 weeks later)
  • Change in Visuospatial Reasoning - mental transformation(Pre-test (baseline) and post-test 6-8 weeks later)
  • Change in Attention(Pre-test (baseline) and post-test 6-8 weeks later)
  • Change in Mindfulness(Pre-test (baseline) and post-test 6-8 weeks later)
  • Change in Mental Wellbeing(Pre-test (baseline) and post-test 6-8 weeks later)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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