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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amy M Young, BBA
- Número de teléfono: 9196965364
- Correo electrónico: amy@jigsawdio.com
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University
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Contacto:
- Maria Marquine, PhD
- Número de teléfono: (919) 681-2980
- Correo electrónico: maria.marquine@duke.edu
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Texas
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College Station, Texas, Estados Unidos, 77843
- Texas A&M University
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Contacto:
- Junhyoung Kim, PhD
- Número de teléfono: 979-436-9372
- Correo electrónico: kim9@tamu.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Global Cognition Measured by the Montreal Cognitive Assessment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Junhyoung Kim, PhD, Texas A&M University
- Investigador principal: Maria Marquine, PhD, Duke University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2R44AG079736-02A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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.
Información sobre medicamentos y dispositivos, documentos del estudio
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