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

23 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
    • Texas
      • College Station, Texas, Förenta staterna, 77843
        • Texas A&M University
        • Kontakt:
          • Junhyoung Kim, PhD
          • Telefonnummer: 979-436-9372
          • E-post: kim9@tamu.edu

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

60 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Aktiv komparator: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Global Cognition Measured by the Montreal Cognitive Assessment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Week 6

Participant and caregiver satisfaction, perceived benefits, and challenges associated with the program will be assessed through feedback interviews.
Week 6
Recruitment Rate
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Callahan-Young LLC DBA Jigsawdio

Samarbetspartners

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

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 maj 2027

Avslutad studie (Beräknad)

1 maj 2027

Studieregistreringsdatum

Först inskickad

13 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

18 september 2026

Första postat (Faktisk)

24 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2R44AG079736-02A1 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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