Experimental vs Wait-List Control: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.11 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0 | 0 | 0.114 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0 | -0.114 | 0.11 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | ClinicalTrials.gov | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | ClinicalTrials.gov | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Experimental | After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.~User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression. | 0 | 31 | EG000 | ClinicalTrials.gov |
| Group 2 | Wait-List Control | After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., mild dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.~User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression. | 0 | 30 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | User-Led Meaningful Activity and Early-Stage Dementia | ClinicalTrials.gov |
| NCT number | NCT05159869 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | Dementia | ClinicalTrials.gov |
| Interventions | User-Led Meaningful Activity Plan | ClinicalTrials.gov |
| Lead sponsor | Johns Hopkins University | ClinicalTrials.gov |
| Results first posted | 2026-01-12 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05159869?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.