Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study would investigate the effect of a cognitive digital therapeutics system. The intervention group would receive three digital therapeutics sessions per week for 8 weeks, while the control group would receive usual care. Evaluations would be done at baseline, week 8, and week 16.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Digital therapeutics session three times per week |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital therapeutics session | Device | During the digital therapeutics session, the patient performs tasks by handling objects according to instructions displayed by the device. A camera records the task performance, and the system analyzes the task performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Instrumental Activities of Daily Living (IADL) | e.g., K-IADL (Korean Instrumental Activities of Daily Living): range from 0 to 33; Higher scores = worse outcomes, lower scores = better independence. | Baseline, Week 8, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| The Montreal Cognitive Assessment (MoCA) | Range: 0 to 30; Higher scores indicate better cognitive function. | Baseline, Week 8, Week 16 |
| Mini-Mental State Examination score (MMSE) | Range: 0 to 30; Higher scores indicate better cognitive function. |
| Measure | Description | Time Frame |
|---|---|---|
| Geriatric Depression Scale (GDS-15) | Range: 0 to 15; Higher scores indicate greater levels of depressive symptoms. | Baseline, Week 8, Week 16 |
| The Family Confusion Assessment Method (FAM-CAM) | Range: Scored as present or absent; Presence indicates delirium. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian-Shin Yeh, MD, MMSc, PhD | Contact | +886978730373 | tianshin.yeh@gmail.com | |
| Jowy Tani, MD, PhD | Contact | +886965562798 | jowytani@tmu.edu.tw |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Wan Fang Hospital | Recruiting | Taipei City | Taipei | 116 | Taiwan |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, Week 8, Week 16 |
| Clinical Dementia Rating score (CDR) | Range: 0 to 3; Higher scores indicate greater severity of dementia. | Baseline, Week 8, Week 16 |
| Executive Function Performance Test score (EFPT) | Range: 0 to 100; Higher scores indicate worse executive functioning. | Baseline, Week 8, Week 16 |
| Baseline, Week 8, Week 16 |
| Activities of Daily Living (ADL) score | Higher scores indicate greater independence: e.g., Katz ADL--range from 0 to 6; Barthel Index--range from 0 to 100. | Baseline, Week 8, Week 16 |
| WAIS-III Digit span forward, backward, and sequencing | Range: Variable (raw scores depend on the total number of correct trials, typically ranging from 0 to ~30, depending on individual performance). Standardized Scoring: Raw scores are converted to age-specific scaled scores, typically ranging from 1 to 19. Interpretation: Higher scores indicate better short-term memory, working memory, and cognitive processing capacity. | Baseline, Week 8, Week 16 |
| Frontal assessment battery (FAB) subtest 5 | Range: 0 to 3. Interpretation: Higher scores indicate better motor programming and cognitive flexibility, reflecting improved frontal lobe function. | Baseline, Week 8, Week 16 |
| Zarit Burden Interview (ZBI) | Range: 0 to 88 (for the full scale) Interpretation: Higher scores indicate greater caregiver burden. | Baseline, Week 8, Week 16 |
| Neuropsychiatric Inventory (NPI) | Range: 0 to 144; Higher scores indicate more severe neuropsychiatric symptoms across assessed domains | Baseline, Week 8, Week 16 |
| Quality of Life Outcome for Patients with Neurologic Conditions (PROMIS) | Range: Standardized T-score, typically 20 to 80; Higher scores can indicate better or worse outcomes depending on the specific domain | Baseline, Week 8, Week 16 |