About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Jigsawdio Multisensory Puzzle Platform
BehavioralJigsawdio 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.
Standard Jigsaw Puzzle Activity
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Quality of Life Measured by the Quality of Life in Alzheimer's Disease Scale
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.
Change in Depressive Symptoms Measured by the Geriatric Depression Scale-15
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.
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7
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.
Secondary outcomes
Change in Global Cognition Measured by the Montreal Cognitive Assessment
Global cognition will be measured using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Change in PROMIS® Cognitive Function v2.0. Short Form 6a T-score
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.
Change in Caregiver-Reported Quality of Life
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.
Participant Engagement During Puzzle Sessions
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.
Sponsors and contacts
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Callahan-Young LLC DBA Jigsawdio
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Texas A&M University
Collaborator
Duke University
Collaborator
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