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Jigsawdio Multisensory Platform for People With Mild Cognitive Impairment, Alzheimer's Disease, or Related Dementias

23 september 2026 bijgewerkt door: Callahan-Young LLC DBA Jigsawdio

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27710
    • Texas
      • College Station, Texas, Verenigde Staten, 77843
        • Texas A&M University
        • Contact:
          • Junhyoung Kim, PhD
          • Telefoonnummer: 979-436-9372
          • E-mail: kim9@tamu.edu

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

60 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Age: 60 years or older.
  2. Able to communicate fluently in English.
  3. Mild cognitive impairment or mild dementia based on an existing diagnosis or study screening procedures.
  4. 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:

  1. Severe uncorrected visual or hearing impairment that would prevent puzzle use.
  2. Severe motor impairment that would prevent puzzle use.
  3. Concurrent participation in a similar program or Alzheimer's disease intervention study.
  4. Current hospice care or terminal illness.
  5. Plans to relocate within three months after the baseline assessment.
  6. History of a serious mental illness, such as bipolar disorder or schizophrenia, that would interfere with study participation.
  7. Unable to provide informed consent and no legally authorized representative is available

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Jigsawdio Multisensory Puzzle Platform

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.
Actieve vergelijker: 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.
Gedragsmatig: Standard Jigsaw Puzzle 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale
Tijdsspanne: 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.
Baseline, Week 6, and Week 12
Change in Depressive Symptoms Measured by the Geriatric Depression Scale-15
Tijdsspanne: 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.
Baseline, Week 6, and Week 12
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7
Tijdsspanne: 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.
Baseline, Week 6, and Week 12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Global Cognition Measured by the Montreal Cognitive Assessment
Tijdsspanne: Baseline, Week 6, and Week 12

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
Change in PROMIS® Cognitive Function v2.0. Short Form 6a T-score
Tijdsspanne: Baseline, Week 6, and Week 12

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
Change in Caregiver-Reported Quality of Life
Tijdsspanne: Baseline, Week 6, and Week 12

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
Participant Engagement During Puzzle Sessions
Tijdsspanne: During each of the 12 puzzle sessions over Weeks 1-6

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
Session Completion and Program Adherence
Tijdsspanne: Through Week 6

Adherence will be measured as the number and percentage of the 12 scheduled puzzle sessions completed by each participant.
Through Week 6
Time on Task
Tijdsspanne: During each of the 12 puzzle sessions over Weeks 1-6.

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.
Participant and Caregiver Satisfaction and Acceptability
Tijdsspanne: Week 6

Participant and caregiver satisfaction, perceived benefits, and challenges associated with the program will be assessed through feedback interviews.
Week 6
Recruitment Rate
Tijdsspanne: At completion of enrollment, up to 7 months

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
Retention Rate
Tijdsspanne: Through Week 12

Retention will be measured as the number and percentage of enrolled participants who complete the Week 12 follow-up assessment.
Through Week 12

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Callahan-Young LLC DBA Jigsawdio

Medewerkers

Duke University
National Institute on Aging (NIA)
Texas A&M University

Onderzoekers

  • Hoofdonderzoeker: Junhyoung Kim, PhD, Texas A&M University
  • Hoofdonderzoeker: Maria Marquine, PhD, Duke University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

13 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 september 2026

Eerst geplaatst (Werkelijk)

24 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

23 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2R44AG079736-02A1 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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-toegangscriteria voor delen

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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