This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial (NCT03907410), a randomized na study. The primary outcome is Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03907410 |
| Phase | NA |
| Condition | Medication Adherence, Asthma in Children |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 125 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Children's Hospital of Philadelphia |
| Results posted | Yes |
2. Clinical Question
The central question is whether adding nominal financial incentives to daily adherence reminders and performance feedback changes adherence to prescribed inhaled corticosteroids among children with asthma. The registry also includes a reminders-and-feedback-only arm and a control arm, so the intervention components can be considered in relation to more than one comparison. However, the posted primary outcome is not reduced to a single comparison, and numerical arm-specific results are not reported in the registry record.
Population
Children with asthma who were prescribed inhaled corticosteroids. The trial summary emphasizes urban minority pediatric populations, but detailed eligibility criteria and the enrolled participants’ demographic characteristics are not reported in the registry record.
Intervention
Nominal financial incentives together with daily adherence reminders and adherence performance feedback. The registry describes this as the incentives, reminders and feedback arm.
Comparator
The other arms received reminders and feedback without nominal financial incentives, or no component of the incentives, reminders and feedback intervention during the experiment period.
Primary question
How mean monthly adherence to the inhaled corticosteroid regimen, measured as the proportion of prescribed doses taken, varied by study arm during the 6 months of follow-up.
The question concerns medication-taking behavior as measured over time, not only a single endpoint at the end of follow-up. The registry lists additional outcomes concerning adherence trajectory, child asthma control, asthma-related healthcare events and healthcare costs. Their presence indicates a broader set of research questions, but the record does not provide enough numerical results to describe the magnitude or precision of the primary arm comparisons.
3. Trial Design
This was a randomized, double-masked, parallel trial with a recorded enrollment of 125. The trial is marked completed, and its phase is listed as not applicable. The registry identifies the sponsor as Children's Hospital of Philadelphia. The listed start and primary-completion dates are 2019-09-01 and 2022-07-17.
The registry describes a run-in period at Month 0, during which eligibility for randomization was determined and baseline adherence data were collected. It then identifies an experiment period during Months 1-3 and an observation period during Months 4-6. During the experiment period, one arm received incentives together with reminders and feedback; another received reminders and feedback without nominal financial incentives; and the control arm received none of the intervention components. The full descriptions of what each arm received during the observation period are not reported in the registry record.
The term randomized indicates that assignment to study arms was intended to use a random process. Double masking indicates that masking was part of the design, but which individuals or groups were masked is not reported in the registry record. The parallel model means the registry identifies separate study arms rather than describing a crossover design. Details of the randomization procedure, allocation concealment, masking procedures and any measures used to maintain masking are not reported in the registry record.
The trial summary presents improving adherence in urban minority pediatric populations as an important motivation and describes uncertainty about whether adherence can be maintained. That rationale should not be treated as a description of every participant: the enrolled population’s demographic characteristics and the precise eligibility requirements are not reported in the registry record. The recorded enrollment is not, by itself, a description of how many participants contributed data to each outcome or analysis.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 19 participants did not successfully complete the run-in period and, thus, were not randomized. 106 study participants were randomized in a 2:1:2 schema. The caregiver-child dyad was one unit. If the caregiver withdrew from the study, the child also withdrew from the study. Medication adherence was only collected from the child, but caregivers were included in the dyad-language given that they were interacting with certain parts of the intervention employed.
Overall Study
| Stage | Arm 1: Incentives, Plus Reminders & Feedback (IRF) | Arm 2: Reminders & Feedback ONLY | Arm 3 (Control) |
|---|---|---|---|
| STARTED | 42 | 22 | 42 |
| COMPLETED | 38 | 21 | 40 |
| NOT COMPLETED | 4 | 1 | 2 |
Reasons for not completing this period:
| Reason | Arm 1: Incentives, Plus Reminders & Feedback (IRF) | Arm 2: Reminders & Feedback ONLY | Arm 3 (Control) |
|---|---|---|---|
| Lost to Follow-up | 4 | 1 | 1 |
| Lost to follow-up and research burden | 0 | 0 | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The "Sex (Female, Male)" and "Race/Ethnicity, Customized" baseline characteristics for the child were collected from the parent/caregivers involved in the study. These variables were not collected for the parents/caregivers.
| Characteristic | Unit | Arm 1: Incentives, Plus Reminders & Feedback (IRF) | Arm 2: Reminders & Feedback ONLY | Arm 3 (Control) | Total |
|---|---|---|---|---|---|
| Participants analysed | 38 | 21 | 40 | 99 | |
| Age, Customized: Child Age Group – 5-7 years | Participants | 12 | 10 | 18 | 40 |
| Age, Customized: Child Age Group – 8-11 years | Participants | 26 | 11 | 22 | 59 |
| Age, Customized: Mean Caregiver Age | years | 34.2 (SD 5.9) | 34.1 (SD 5.6) | 33.5 (SD 6.7) | 33.8 (SD 6.2) |
| Sex: Female, Male: Child Sex – Female | Participants | 18 | 9 | 16 | 43 |
| Sex: Female, Male: Child Sex – Male | Participants | 20 | 12 | 24 | 56 |
| Race/Ethnicity, Customized: Child Race – Black | Participants | 31 | 17 | 33 | 81 |
| Race/Ethnicity, Customized: Child Race – Non-Black | Participants | 7 | 4 | 7 | 18 |
| Region of Enrollment: United States | participants | 38 | 21 | 40 | 99 |
| Run-in Period ICS Adherence | % of doses taken | 56 (SD 26) | 50 (SD 29) | 52 (SD 30) | 53 (SD 28) |
6. Primary Endpoint
The registry lists the primary outcome as Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted), measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | proportion of prescribed doses taken |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mean monthly adherence to the inhaled corticosteroid regimen over 6 months. Adherence is defined as the mean daily proportion of prescribed doses taken, calculated by study month and study arm. The unit is a proportion of prescribed doses taken. The registry states that days with values greater than 1 were truncated to 1, so a recorded daily value could not contribute more than full adherence under this definition.
This measure is used to describe medication-taking behavior relative to the prescribed regimen. Reporting it by month can show how adherence varies over the follow-up period, rather than reducing behavior across the entire period to one endpoint. In general, repeated monthly summaries can help distinguish patterns over time, but the registry record does not report a fitted trajectory model or a particular statistical method for comparing those patterns.
The registry identifies the summary measure as a mean and its dispersion as a 95% confidence interval. A confidence interval conveys uncertainty around an estimate under the method used to construct it; it does not ensure that the estimate is unbiased or that every relevant source of uncertainty is represented. The numerical monthly means and confidence intervals by arm are not reported in the registry record. The primary endpoint definition is available, but its results cannot be described in terms of observed magnitude or precision from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record specifies a clinically interpretable behavioral endpoint: the mean daily proportion of prescribed inhaled corticosteroid doses taken, summarized by study month and arm. It also specifies a 95% confidence interval as the measure of dispersion. However, the arm-specific means and confidence intervals are not reported in the registry record. Consequently, the size and direction of any observed differences in monthly adherence, and the precision of those differences, cannot be characterized from the record.
The primary outcome is described across study months and arms, rather than as one comparison. The record does not identify a single primary contrast or provide a numerical estimate for one. It therefore does not support a statement about whether the incentives arm differed from the reminders-and-feedback-only arm, whether either differed from control, or by how much. No p-value for a primary comparison is reported in the registry record. The absence of a reported estimate is not evidence that the arms had identical adherence; it means the registry record does not provide the result needed to assess that question.
The trial summary frames sustained adherence as an unresolved issue. A monthly outcome could, in principle, describe change during the experiment and observation periods, but numerical values for those periods are not reported in the registry record. The exact intervention conditions during the observation period are also not fully described there. As a result, the stated design periods should not be mistaken for evidence about the persistence of an intervention effect.
The outcome definition includes a ceiling rule: daily values greater than 1 were set to 1. This helps make the measure conform to its interpretation as a proportion of prescribed doses taken, but the registry does not report how often truncation occurred or how much it affected the summaries. The record also does not report missingness by arm or month, the number of participants contributing to each monthly estimate, or the handling of missing adherence observations. Those details matter when judging whether the observed summaries represent all randomized participants or a subset with available measurements.
The registry lists secondary outcomes concerning adherence trajectory, changes in Child Asthma Control Tool score, asthma-related emergency-room visits, hospitalizations and oral steroid courses, and healthcare costs. Numerical findings for those outcomes are not reported in the registry record. The adverse-event entries provide separate safety counts, but they do not fill the gap in the primary adherence results or establish a relationship between adherence and other outcomes. Overall, the record gives the trial question and endpoint definition but not the primary numerical results needed to estimate an intervention contrast.
9. Statistical Methods Explained
The registry gives some information about the outcome summary but limited information about the statistical analysis. It identifies the primary measure as a mean and reports a 95% confidence interval as its dispersion. It does not describe a model, a prespecified contrast, an approach to repeated observations, or a method for handling missing data. The distinctions below explain what the reported statistical terms mean in general and what can be concluded from the registry record.
What does a mean adherence value represent?
In general, a mean is an average across the observations included in its calculation. Here, the registry defines the daily observation as a proportion of prescribed doses taken, then describes a mean daily proportion by study month and arm. This is a summary of observed adherence on the defined scale; it is not automatically a measure of the effect of assigning an intervention. To interpret a difference as an intervention contrast, readers need the arm-specific estimates and a stated comparison, together with the analysis population and method. Those numerical estimates and analysis details are not reported in the registry record.
The registry says that days with values greater than 1 were truncated to 1. In general, truncation imposes a ceiling on observations that exceed the scale’s intended maximum. It can make the recorded measure easier to interpret as a proportion, but it also means that values above the ceiling do not retain their original magnitude in the summary. The record does not report the frequency of such days or their influence on the results.
What does the 95% confidence interval add?
In general, a confidence interval describes the statistical uncertainty around an estimate under the assumptions of the interval-construction method. A narrower interval indicates greater precision under that method, while a wider interval indicates less precision. The interval does not measure all possible uncertainty, correct bias automatically, or establish that an estimate is clinically important. The registry names a 95% confidence interval but does not report the numerical intervals for the primary outcome. Without those values, precision cannot be assessed from the record.
A confidence interval for an arm-specific mean and a confidence interval for a difference between arms answer different questions. The first concerns the mean in one arm; the second concerns a contrast between arms. The registry does not give a single primary comparison or a numerical contrast. It would therefore be inappropriate to infer a treatment difference from the endpoint definition alone.
How should observations over time be considered?
In general, observations from the same participant over multiple months may be related to one another. Statistical methods for repeated observations can account for that within-participant dependence, whereas a method that treats every observation as independent may not. The registry describes adherence by study month and identifies a 6-month timeframe, but does not report whether the analysis used a repeated-measures model, summarized monthly data separately, or used another approach. No particular correlation structure or model assumptions are reported in the registry record.
Over-dispersion is a general concern when observed variation is greater than a model’s assumptions allow. If a model assumes less variation than the data contain, its uncertainty estimates can be too small. The registry does not describe a count-based model or report an over-dispersion assessment for the primary endpoint. Because the endpoint is described as a mean of proportions, it would be unsupported to claim that over-dispersion was present or that a correction was used. More generally, the appropriate variance assumptions depend on the data structure and analysis method, which are not reported in the registry record.
What is known about planning and statistical testing?
The registry does not report a sample-size justification or the assumptions used in the original trial design. A planning illustration based on an observed effect is a hypothetical calculation, not the trial’s protocol justification and not observed power. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation, with the effect framed as a fraction of the observed effect. Those assumptions do not establish that the trial was designed around that method or that the registry used it for its primary analysis.
A significance level is a design or testing threshold, not a measure of effect size. A p-value, if reported, would describe compatibility between data and a specified statistical model under a null hypothesis; it would not measure the probability that an intervention is effective. The registry record does not report a primary p-value, a testing procedure, or a numerical primary contrast. The significance level used in a planning illustration should not be presented as an observed test result.
The record also does not report the statistical software, model specification, covariate adjustments, diagnostic checks or sensitivity analyses. Those omissions limit independent assessment of the analytical choices. No model or test should be attributed to the trial unless it is documented in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures and 2 analyses. It identifies adherence trajectory, changes in Child Asthma Control Tool score, asthma-related emergency-room visits, hospitalizations and oral steroid courses, and healthcare costs among the secondary outcomes. The primary adherence outcome is described across study months and study arms, rather than as one reduced comparison. This creates multiple potential summaries or contrasts, but the registry does not identify which comparisons were designated as confirmatory or how multiplicity was addressed.
In general, when many hypotheses are tested, the chance of at least one apparently notable result can rise unless the analysis plan accounts for the number and structure of tests. Adjustment is not automatically required for every descriptive summary; the relevant issue is which inferential claims the investigators intended to make and which tests support them. The registry record does not report a multiplicity adjustment, a hierarchy of endpoints, or a prespecified primary contrast. It is therefore not possible to determine from the record how the trial handled multiplicity.
Missing-data methods are also not reported. The registry does not state how missing daily adherence measurements or incomplete follow-up were treated, whether analyses used all randomized participants, or how outcome-specific analysis populations were defined. In general, missingness can affect both an estimate and its uncertainty, especially if the availability of measurements is related to adherence or study assignment. Without arm- and month-specific observation counts and a stated method, the potential impact cannot be evaluated.
These reporting gaps do not demonstrate that an appropriate plan was absent; they mean the plan is not reported in the registry record. The numerical primary results and their analysis population are also not reported, limiting assessment of both multiplicity and missing-data handling.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Arm 1: Incentives, Plus Reminders & Feedback (IRF) | 6 | 38 | 15.8% |
| Arm 2: Reminders & Feedback ONLY | 4 | 21 | 19.0% |
| Arm 3 (Control) | 6 | 40 | 15.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm 1: Incentives, Plus Reminders & Feedback (IRF) | 0 of 38 |
| Arm 2: Reminders & Feedback ONLY | 0 of 21 |
| Arm 3 (Control) | 0 of 40 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Arm 1: Incentives, Plus Reminders & Feedback (IRF) | 17 of 38 |
| Arm 2: Reminders & Feedback ONLY | 13 of 21 |
| Arm 3 (Control) | 22 of 40 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm 1: Incentives, Plus Reminders & Feedback (IRF) | Arm 2: Reminders & Feedback ONLY | Arm 3 (Control) |
|---|---|---|---|---|
| Asthma Exacerbation or Increased Asthma Symptoms | Respiratory, thoracic and mediastinal disorders | 6 of 38 | 4 of 21 | 5 of 40 |
| Abdominal Pain | Gastrointestinal disorders | 1 of 38 | 0 of 21 | 0 of 40 |
| Risk for Neurologic Deterioration | Nervous system disorders | 0 of 38 | 0 of 21 | 1 of 40 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm 1: Incentives, Plus Reminders & Feedback (IRF) | Arm 2: Reminders & Feedback ONLY | Arm 3 (Control) |
|---|---|---|---|---|
| Asthma Exacerbation or Increased Asthma Symptoms | Respiratory, thoracic and mediastinal disorders | 9 of 38 | 8 of 21 | 13 of 40 |
| Joint/Extremity Pain or Fracture | Injury, poisoning and procedural complications | 4 of 38 | 2 of 21 | 4 of 40 |
| Constipation | Gastrointestinal disorders | 1 of 38 | 1 of 21 | 0 of 40 |
| Viral Infection | Infections and infestations | 1 of 38 | 0 of 21 | 1 of 40 |
| Hordeolum Externum | Infections and infestations | 0 of 38 | 1 of 21 | 0 of 40 |
| Chest Pain | Cardiac disorders | 0 of 38 | 0 of 21 | 1 of 40 |
| Otitis Externa | Infections and infestations | 0 of 38 | 1 of 21 | 0 of 40 |
| Seizures | Nervous system disorders | 0 of 38 | 0 of 21 | 1 of 40 |
| Concerns for glass ingestion | Injury, poisoning and procedural complications | 1 of 38 | 0 of 21 | 0 of 40 |
| Flu | Infections and infestations | 0 of 38 | 0 of 21 | 1 of 40 |
Serious events with the highest arm-level rate: asthma exacerbation or increased asthma symptoms (19.0%), abdominal pain (2.6%), risk for neurologic deterioration (2.5%).
The registry lists serious adverse events and other adverse events separately for each arm. For the incentives, reminders and feedback arm, it records 6 participants affected by serious adverse events among 38 at risk, and 17 affected by other adverse events among 38 at risk. For the reminders-and-feedback-only arm, the corresponding figures are 4 among 21 and 13 among 21. For control, the figures are 6 among 40 and 22 among 40. The registry records 0 deaths in each arm.
These are counts of affected participants and the listed numbers at risk, not the primary adherence outcome. The categories of serious and other adverse events should be read as the registry reports them; the record does not clarify whether participants could appear in both categories or how repeated events were counted. The at-risk counts are not described as the denominator for every event term, so percentages attached to individual terms should not be converted into counts or treated as directly comparable rates without further information.
The registry’s listed serious-event terms include Asthma Exacerbation or Increased Asthma Symptoms at 19.0%, Abdominal Pain at 2.6%, and Risk for Neurologic Deterioration at 2.5%. The record does not provide enough detail alongside these percentages to establish their denominators or to determine whether they represent participant-level risks or another event summary. These entries describe reported safety data; they do not, on their own, establish that an event was caused by a study intervention or that event rates differed between arms.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the trial was designed to examine adherence to inhaled corticosteroids in children with asthma, with a randomized comparison involving incentives, reminders and feedback, reminders and feedback alone, and control. It defines the primary outcome and reports that monthly summaries were intended over 6 months. Those details clarify the research question and the scale on which adherence was measured.
The record does not report the numerical primary-outcome means or their 95% confidence intervals. It also does not present a single numerical comparison among the arms. Therefore, the magnitude, direction and precision of any difference in adherence cannot be determined from the registry record. This lack of a reported estimate should not be interpreted as evidence of no difference, nor as evidence of a difference. It leaves the primary comparative result unresolved in the available record.
The outcome is a measure of medication-taking behavior, not a direct measure of asthma control or of asthma-related healthcare use. The registry lists those and other outcomes separately, but their numerical results are not reported in the record. Likewise, the safety counts are descriptive entries and do not establish causal relationships with the assigned interventions. Conclusions about adherence, asthma outcomes, costs or intervention-related harms would require results and analysis details beyond the endpoint definitions and counts listed.
In general, a well-defined outcome can make a trial’s intended measurement clear, but interpretation of an intervention effect requires results, a specified contrast and sufficient information about the analysis. The record provides the measurement definition and trial structure, while leaving those elements incomplete for the primary outcome. It also does not report the statistical plan, missing-data approach, outcome-specific analysis populations or multiplicity strategy. These gaps limit the strength of any statistical conclusion that can be drawn from the registry record alone.
13. Why This Trial Matters Statistically
This trial raises a useful statistical question about how to evaluate medication adherence as a behavior that can change over time. Its primary outcome is defined as the mean daily proportion of prescribed inhaled corticosteroid doses taken by study month and arm. That definition makes the endpoint concrete, while the monthly structure highlights that the research question is not necessarily limited to one endpoint measurement at the end of follow-up.
The intervention also has distinct components: nominal financial incentives and daily reminders with adherence performance feedback. Including a reminders-and-feedback-only arm alongside an incentives arm creates a design capable of addressing whether the combination differs from reminders and feedback alone, while the control arm supplies another comparison. The registry record, however, does not report the primary numerical results or a single primary contrast. The design’s potential comparisons should not be confused with findings about those comparisons.
Statistically, the study illustrates why endpoint definition, analysis structure and reporting need to align. Repeated monthly adherence observations may call for attention to within-participant dependence, and the ceiling rule for values greater than 1 affects how the outcome is represented. The registry identifies the mean and a 95% confidence interval but does not report the model or the interval estimates. Readers therefore cannot evaluate the precision of the results or the methods used to account for the data structure.
The registry also lists several secondary outcomes and safety summaries, underscoring the need to distinguish outcome domains and clarify which comparisons support confirmatory claims. With no reported multiplicity strategy, missing-data method or numerical primary estimates, the record is informative about the question and design but limited as a source for judging the statistical evidence.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpretation is that numerical primary-outcome results are not reported in the registry record. The mean monthly adherence estimates and their 95% confidence intervals are absent, and the primary outcome is not reduced to one comparison. This prevents assessment of the estimated differences, their direction and their precision.
The statistical analysis plan is not reported in the registry record. In particular, the record does not describe how monthly observations were analyzed, which contrasts were prespecified, whether covariates were included, or how repeated observations from the same participant were handled. It also does not specify the analysis population or report the number contributing to each month’s outcome.
The handling of missing adherence measurements is not reported. The record does not describe patterns of missing data, reasons for missingness, or methods used to address incomplete observations. The extent to which missingness could affect the estimates therefore cannot be evaluated. The registry also does not report a multiplicity strategy despite listing several outcomes and analyses.
Design details are incomplete for interpretation of the intervention periods. The record describes the run-in, experiment and observation periods, but the full arm descriptions for the observation period are not reported. It does not identify who was masked or describe the procedures used to maintain masking. Detailed eligibility criteria and the demographic characteristics of the enrolled population are also not reported; the trial summary’s focus on urban minority pediatric populations should not be taken as a complete account of the enrolled sample.
The safety entries give affected-participant counts and numbers at risk, but the registry does not provide enough detail to establish event-term denominators, overlap between categories, or causal attribution. These limitations concern what can be assessed from the registry record; they do not establish that the trial did not collect or analyze information that is not reported there.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial — NCT03907410.
- Registry record last updated 2024-03-18; status last verified 2024-03.
- Results first posted 2024-03-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03907410 is a completed randomized, double-masked, parallel trial with recorded enrollment of 125. It studied nominal financial incentives, daily adherence reminders and adherence performance feedback among children with asthma who were prescribed inhaled corticosteroids. The design included a reminders-and-feedback-only arm and a control arm, with a run-in at Month 0, an experiment period during Months 1-3 and an observation period during Months 4-6.
The primary endpoint was mean monthly adherence over 6 months, defined as the mean daily proportion of prescribed doses taken by arm. Days with values greater than 1 were truncated to 1; the registry specified a 95% confidence interval. The arm-specific primary estimates and confidence intervals are not reported in the registry record, and no single primary comparison is given. The record also does not report the analysis plan, missing-data approach, analysis populations or multiplicity strategy. Safety entries list serious and other adverse events by arm and 0 deaths in each arm.