This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
AERIS is a randomized parallel-group clinical trial evaluating whether a pharmacist-led mobile health serious game intervention changes COPD health status compared with usual care during a 3-month follow-up period.
| Feature | AERIS |
|---|---|
| Clinical condition | COPD; COPD (Chronic Obstructive Pulmonary Disease) |
| Phase | NA |
| Status | ACTIVE_NOT_RECRUITING |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None |
| Primary purpose | Treatment |
| Lead sponsor | Universitas Katolik Widya Mandala Surabaya |
2. Clinical Question
The primary clinical question is whether a pharmacist-led mHealth serious game intervention improves COPD health status compared with usual care during a 3-month follow-up period.
Population
Patients with chronic obstructive pulmonary disease.
Intervention
Pharmacist-Led mHealth Serious Game.
Comparator
Usual Care.
Primary question
Does the intervention change COPD health status over time?
3. Trial Design
| Arm | Intervention |
|---|---|
| Experimental arm | Pharmacist-Led mHealth Serious Game (behavioral) |
| Control arm | Usual Care (other) |
4. Endpoints
| Endpoint | Definition | Time frame |
|---|---|---|
| Change in COPD health status | Health status will be assessed using the COPD Assessment Test (CAT). The outcome will be defined as the change in CAT score from baseline during the 3-month follow-up period. | Baseline, 1 month, 2 months and 3 months |
5. Planned Analysis
The ClinicalTrials.gov record identifies change in COPD health status as the primary endpoint but does not report posted statistical analyses or outcome results.
The primary endpoint is a repeated measurement of CAT score collected at baseline, 1 month, 2 months, and 3 months. A typical analysis for this type of endpoint would compare the pattern of change from baseline between randomized groups while accounting for the correlation among repeated measurements within the same participant.
A mixed-effects model for repeated measures is one possible framework for analyzing longitudinal continuous outcomes because it can incorporate measurements collected at multiple follow-up visits while accounting for within-participant correlation.
6. Statistical Methodology
Randomized comparison
Randomization is the foundation of the treatment comparison. By assigning participants to intervention groups through a random process, the study design aims to balance measured and unmeasured factors between groups at baseline.
Longitudinal outcome analysis
The primary endpoint is not a single measurement but a change trajectory across multiple visits. Statistical models for repeated measures focus on whether the pattern of CAT score change differs between groups rather than simply comparing one isolated time point.
Baseline adjustment
For change-from-baseline outcomes, adjustment for baseline CAT score can improve precision by accounting for initial differences in health status while preserving the randomized comparison.
Missing follow-up measurements
Longitudinal trials commonly encounter incomplete follow-up measurements. The appropriate handling approach depends on the statistical analysis plan, assumptions about missingness, and the observed follow-up pattern.
7. Statistical Methods Explained
Why is CAT score measured repeatedly?
Repeated assessments at baseline, 1 month, 2 months, and 3 months allow investigators to evaluate how COPD health status changes over time rather than relying on a single endpoint measurement.
Why might a mixed-effects model be used?
Repeated observations from the same participant are correlated. Mixed-effects models can account for this within-person correlation while estimating differences between randomized groups.
What does a treatment-by-time interaction mean?
A treatment-by-time interaction tests whether the pattern of change over follow-up differs between the intervention and usual-care groups.
Why analyze change from baseline?
Change-from-baseline analysis focuses on improvement or worsening relative to each participant's starting health status.
Why does randomization matter?
Randomization supports causal interpretation because treatment groups are formed before outcomes are observed.
8. Limitations
- No posted outcome analyses: The registry does not report statistical estimates, confidence intervals, or p-values for the primary endpoint.
- Open-label design: Because masking is listed as none, awareness of treatment assignment may influence behavioral outcomes such as self-reported health status.
- Patient-reported outcome: CAT scores reflect participant-reported health status and may be influenced by perceptions and expectations.
- Follow-up duration: The primary endpoint evaluates a 3-month follow-up period, which captures short-term change rather than long-term disease progression.
- Analysis assumptions: The final interpretation depends on the prespecified statistical analysis plan, including handling of missing data and model assumptions.
9. Why This Trial Matters Statistically
AERIS illustrates several important principles in modern clinical-trial statistics: randomized allocation, longitudinal outcomes, patient-reported measures, and analysis of change over time.
| Concept | How it appears in AERIS |
|---|---|
| Randomization | Participants are assigned through a randomized design. |
| Parallel groups | Two-arm comparison between intervention and usual care. |
| Repeated measures | CAT assessments at baseline, 1 month, 2 months and 3 months. |
| Continuous outcome | CAT score change is the primary endpoint measure. |
| Longitudinal modeling | Analysis focuses on change across multiple time points. |
| Patient-reported outcomes | Health status is assessed using the COPD Assessment Test. |
10. Sources
- ClinicalTrials.gov: NCT07469904.
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11. Record Summary
AERIS is a randomized parallel-group trial evaluating a pharmacist-led mHealth serious game intervention for patients with COPD. Its primary endpoint is change in COPD health status measured by CAT score from baseline through 3 months. The registry describes the trial design and endpoint framework, while outcome analyses have not yet been posted in ClinicalTrials.gov.