Evaluating the Health Benefits of Jigsawdio: A Novel Multisensory Jigsaw Puzzle-Based Platform for Alzheimer's Disease and Related Dementias
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale
研究概览
简要总结
This study will evaluate Jigsawdio, a personalized multisensory jigsaw puzzle platform, for adults aged 60 years and older with mild cognitive impairment or mild dementia. Approximately 80 participants will be randomly assigned to either the Jigsawdio group or a control group using standard dementia-friendly jigsaw puzzles. Both groups will complete two 30- to 40-minute puzzle sessions per week for six weeks, for a total of 12 sessions.
Jigsawdio combines transparent physical puzzle pieces with personalized images, stories, and audio presented through an iPad. The study will compare changes in depression, anxiety, quality of life, cognition, engagement, satisfaction, and program feasibility. Assessments will be completed at baseline, after the six-week program, and at a 12-week follow-up. Information may also be collected from participants' caregivers or informants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 60 years or older.
- •Able to communicate fluently in English.
- •Mild cognitive impairment or mild dementia based on an existing diagnosis or study screening procedures.
- •Has an informant and a puzzle creator who know the participant and are willing to participate in the study; the same person may serve in both roles.
排除标准
- •Severe uncorrected visual or hearing impairment that would prevent puzzle use.
- •Severe motor impairment that would prevent puzzle use.
- •Concurrent participation in a similar program or Alzheimer's disease intervention study.
- •Current hospice care or terminal illness.
- •Plans to relocate within three months after the baseline assessment.
- •History of a serious mental illness, such as bipolar disorder or schizophrenia, that would interfere with study participation.
- •Unable to provide informed consent and no legally authorized representative is available
研究组 & 干预措施
Standard Jigsaw Puzzle Program
Participants will complete two approximately 30- to 40-minute standard jigsaw puzzle sessions per week for six weeks, for a total of 12 sessions. Commercially available dementia-friendly puzzles will be used as the comparison activity.
干预措施: Standard Jigsaw Puzzle Activity (Behavioral)
Jigsawdio Multisensory Puzzle Program
Participants will complete two 30 to 40 minute Jigsawdio sessions per week for six weeks, for a total of 12 sessions. Jigsawdio combines transparent physical puzzle pieces with personalized images, stories, and audio presented through an iPad.
干预措施: Jigsawdio Multisensory Puzzle Platform (Behavioral)
结局指标
主要结局
Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale
时间窗: Baseline, Week 6, and Week 12
Quality of life will be measured using the Quality of Life in Alzheimer's Disease scale (QoL-AD). Total scores range from 13 to 52, with higher scores indicating better quality of life.
Change in Depressive Symptoms Measured by the Geriatric Depression Scale-15
时间窗: Baseline, Week 6, and Week 12
Depressive symptoms will be measured using the 15-item Geriatric Depression Scale (GDS-15). Total scores range from 0 to 15, with higher scores indicating greater depressive symptoms.
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7
时间窗: Baseline, Week 6, and Week 12
Anxiety symptoms will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.
次要结局
- Change in Global Cognition Measured by the Montreal Cognitive Assessment(Baseline, Week 6, and Week 12)
- Participant and Caregiver Satisfaction and Acceptability(Week 6)
- Change in PROMIS® Cognitive Function v2.0. Short Form 6a T-score(Baseline, Week 6, and Week 12)
- Change in Caregiver-Reported Quality of Life(Baseline, Week 6, and Week 12)
- Participant Engagement During Puzzle Sessions(During each of the 12 puzzle sessions over Weeks 1-6)
- Session Completion and Program Adherence(Through Week 6)
- Time on Task(During each of the 12 puzzle sessions over Weeks 1-6.)
- Recruitment Rate(At completion of enrollment, up to 7 months)
- Retention Rate(Through Week 12)