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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Amy M Young, BBA
- Numéro de téléphone: 9196965364
- E-mail: amy@jigsawdio.com
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University
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Contact:
- Maria Marquine, PhD
- Numéro de téléphone: (919) 681-2980
- E-mail: maria.marquine@duke.edu
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Texas
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College Station, Texas, États-Unis, 77843
- Texas A&M University
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Contact:
- Junhyoung Kim, PhD
- Numéro de téléphone: 979-436-9372
- E-mail: kim9@tamu.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Global Cognition Measured by the Montreal Cognitive Assessment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Junhyoung Kim, PhD, Texas A&M University
- Chercheur principal: Maria Marquine, PhD, Duke University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2R44AG079736-02A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Délai de partage 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.
Critères d'accès au partage 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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