Jigsawdio Multisensory Platform for People With Mild Cognitive Impairment, Alzheimer's Disease, or Related Dementias
Evaluating the Health Benefits of Jigsawdio: A Novel Multisensory Jigsaw Puzzle-Based Platform for Alzheimer's Disease and Related Dementias
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Amy M Young, BBA
- 電話番号：9196965364
- メール：amy@jigsawdio.com
研究場所
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke University
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コンタクト：
- Maria Marquine, PhD
- 電話番号：(919) 681-2980
- メール：maria.marquine@duke.edu
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Texas
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College Station、Texas、アメリカ、77843
- Texas A&M University
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コンタクト：
- Junhyoung Kim, PhD
- 電話番号：979-436-9372
- メール：kim9@tamu.edu
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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. |
Jigsawdio is a personalized multisensory puzzle platform that combines transparent physical puzzle pieces with images, stories, and audio presented through an iPad. Participants will complete two approximately 30- to 40-minute Jigsawdio sessions per week for six weeks, for a total of 12 sessions. |
|
アクティブコンパレータ：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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale
時間枠：Baseline, Week 6, and Week 12
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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. |
Baseline, Week 6, and Week 12
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Change in Depressive Symptoms Measured by the Geriatric Depression Scale-15
時間枠：Baseline, Week 6, and Week 12
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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. |
Baseline, Week 6, and Week 12
|
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Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7
時間枠：Baseline, Week 6, and Week 12
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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. |
Baseline, Week 6, and Week 12
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Global Cognition Measured by the Montreal Cognitive Assessment
時間枠：Baseline, Week 6, and Week 12
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Global cognition will be measured using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive performance. |
Baseline, Week 6, and Week 12
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Change in PROMIS® Cognitive Function v2.0. Short Form 6a T-score
時間枠：Baseline, Week 6, and Week 12
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Perceived cognitive function will be measured using the six-item Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function v2.0 Short Form 6a. Raw scores are converted to standardized T-scores ranging from 23.13 to 63.17, with higher scores indicating better perceived cognitive function. |
Baseline, Week 6, and Week 12
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Change in Caregiver-Reported Quality of Life
時間枠：Baseline, Week 6, and Week 12
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Caregivers or informants will complete the proxy version of the Quality of Life in Alzheimer's Disease scale. Scores range from 13 to 52, with higher scores indicating better perceived quality of life. |
Baseline, Week 6, and Week 12
|
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Participant Engagement During Puzzle Sessions
時間枠：During each of the 12 puzzle sessions over Weeks 1-6
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Engagement will be evaluated during puzzle sessions using the Engagement of a Person with Dementia Scale (EPWDS). Each of the 10 items is rated from 1 to 5. Items 2, 4, 6, 8, and 10 are reverse scored. Total scores range from 10 to 50, with higher scores indicating greater positive engagement. |
During each of the 12 puzzle sessions over Weeks 1-6
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Session Completion and Program Adherence
時間枠：Through Week 6
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Adherence will be measured as the number and percentage of the 12 scheduled puzzle sessions completed by each participant. |
Through Week 6
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Time on Task
時間枠：During each of the 12 puzzle sessions over Weeks 1-6.
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The amount of time each participant spends engaged in each puzzle session will be recorded in minutes. |
During each of the 12 puzzle sessions over Weeks 1-6.
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Participant and Caregiver Satisfaction and Acceptability
時間枠：Week 6
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Participant and caregiver satisfaction, perceived benefits, and challenges associated with the program will be assessed through feedback interviews. |
Week 6
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Recruitment Rate
時間枠：At completion of enrollment, up to 7 months
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Recruitment feasibility will be measured as the number and percentage of screened individuals who enroll in the study. |
At completion of enrollment, up to 7 months
|
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Retention Rate
時間枠：Through Week 12
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Retention will be measured as the number and percentage of enrolled participants who complete the Week 12 follow-up assessment. |
Through Week 12
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協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Junhyoung Kim, PhD、Texas A&M University
- 主任研究者：Maria Marquine, PhD、Duke University
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 2R44AG079736-02A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Deidentified individual participant data underlying the study results will be shared through the Texas Data Repository. Shared data may include sociodemographic information, survey outcome data, and coded qualitative interview data. Direct identifiers and identifiable raw interview data will not be shared. Supporting materials may include metadata, codebooks, permitted data collection instruments, the study protocol, and analytic code. Access and reuse will be consistent with participant consent, applicable IRB requirements, and institutional data-sharing policies.
IPD 共有時間枠
Deidentified individual participant data will be made available following publication of the primary study results and will be preserved for long-term access in accordance with repository policies.
IPD 共有アクセス基準
Deidentified individual participant data will be available through the Texas Data Repository to qualified researchers for purposes consistent with participant consent and applicable ethical requirements. Access will be subject to applicable institutional and IRB requirements and the repository's terms of access.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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