Trial · NCT07913243
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adherence Rate to Digital Cognitive Training During the Intervention Period | Weeks 2-13 (84 days) | The primary outcome is the completion rate of digital cognitive training during the 12-week intervention period (Weeks 2-13, 84 days). Completion rate is defined as the number of days on which all prescribed training tasks were completed divided by 84 days, multiplied by 100%. Participants who withdraw or do not train on a given day are counted as non-adherent, with the denominator remaining 84 days. The primary comparison is between the combined incentive groups and the control group. |
| Secondary | Stage-Specific Completion Rate of Digital Cognitive Training | Week 1; Weeks 2-13; Weeks 14-17 | Completion rate calculated separately for the run-in period (Week 1, 7 days), intervention period (Weeks 2-13, 84 days), and follow-up period (Weeks 14-17, 28 days). For each stage, completion rate = number of days with all prescribed tasks completed / total days in that stage × 100%. |
| Secondary | Stage-Specific Participation Rate | Week 1; Weeks 2-13; Weeks 14-17 | Participation rate calculated separately for the run-in, intervention, and follow-up periods. Participation rate = number of days with APP login and at least 1 completed training task / total days in that stage × 100%. This distinguishes "starting training" from "completing all tasks". |
| Secondary | Mean Daily Number of Training Tasks Completed | Week 1; Weeks 2-13; Weeks 14-17 | Average number of training tasks completed per day during the run-in, intervention, and follow-up periods, recorded automatically by the APP. This reflects training dose. |
| Secondary | Weekly Trend in Mean Daily Training Tasks | Weeks 1-17 (weekly) | Weekly average number of daily training tasks from Week 1 to Week 17, analyzed using a linear mixed model to assess changes over time and differences between groups. Used to evaluate whether incentive effects decay and how training behavior changes after incentive withdrawal. |
| Secondary | Change in Montreal Cognitive Assessment (MoCA) Score | Baseline; Week 14 | Change in MoCA total score from baseline to post-intervention (Week 14). MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function. Administered on-site by trained researchers using a standardized protocol. |
| Secondary | Change in DiaMem Score | Baseline; Week 14 | Change in DiaMem score from baseline to post-intervention (Week 14). DiaMem score is the mean of three tests (one on-site and two home-based), ranging from 0 to 100. Higher scores indicate better cognitive function. |
| Secondary | Proportion of Participants Achieving High Adherence (≥80%) | Weeks 2-13 | Proportion of participants in each group with an intervention-period completion rate ≥80%. Numerator: number of participants with completion rate ≥80%; denominator: number of randomized participants who did not withdraw informed consent. |
| Secondary | Recruitment Rate | Recruitment period | Proportion of older adults in the target community who actively contacted the researcher, underwent preliminary screening, signed informed consent, and successfully downloaded the cognitive training APP. Numerator: number of such participants; denominator: total number of age-eligible (≥60 years) smartphone-using older adults in the community during the same period. |
| Secondary | Run-in Completion Rate | End of Week 1 | Proportion of participants who passed the 1-week run-in and could independently complete at least 2 days of cognitive training. Numerator: number of such participants; denominator: all participants who signed informed consent and downloaded the APP. |
| Secondary | Retention Rate | Week 14 (end of 12-week intervention) | Proportion of participants who completed the 12-week intervention and received the final assessment. Completion of the 12-week intervention is defined as completing at least 1 day of training in each of the 12 weeks. Numerator: number completing and assessed; denominator: total randomized participants. |
| Secondary | Researcher Time Input per Participant | From enrollment to end of intervention (Week 13) | Total time in minutes spent by researchers on training, answering questions, active contact, and data verification for each participant from enrollment to the end of the intervention period. Used for cost estimation. |
| Other | Incidence of Adverse Events | Throughout the study (up to Week 17) | Number and proportion of participants experiencing adverse events during the study period. Serious adverse events will be reported promptly to the ethics committee. |
| Other | User Experience Assessed by the Short Version of the User Experience Questionnaire (UEQ-S) | Week 14 | User experience with the digital cognitive training app will be assessed at the post-intervention assessment (Week 14) using the Short Version of the User Experience Questionnaire (UEQ-S). The UEQ-S contains 8 items rated on a 7-point semantic differential scale and yields two subscale scores, pragmatic quality and hedonic quality, as well as an overall user experience score. Higher scores indicate more positive user experience. The UEQ-S will be used as an indicator of participant acceptance of and user experience with the training app. Open-ended feedback on the training program and incentive scheme may be collected separately. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07913243/registered