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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Amy M Young, BBA
- Telefonní číslo: 9196965364
- E-mail: amy@jigsawdio.com
Studijní místa
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North Carolina
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Durham, North Carolina, Spojené státy, 27710
- Duke University
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Kontakt:
- Maria Marquine, PhD
- Telefonní číslo: (919) 681-2980
- E-mail: maria.marquine@duke.edu
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Texas
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College Station, Texas, Spojené státy, 77843
- Texas A&M University
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Kontakt:
- Junhyoung Kim, PhD
- Telefonní číslo: 979-436-9372
- E-mail: kim9@tamu.edu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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. |
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Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale
Časové okno: 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
Časové okno: 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
Časové okno: 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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Global Cognition Measured by the Montreal Cognitive Assessment
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Junhyoung Kim, PhD, Texas A&M University
- Vrchní vyšetřovatel: Maria Marquine, PhD, Duke University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2R44AG079736-02A1 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
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.
Kritéria přístupu pro sdílení IPD
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.
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