Attitudes Towards Receiving Mental Health Care Using Telehealth During the Coronavirus Disease 2019 (COVID-19) Pandemic: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Attitudes Towards Receiving Mental Health Care Using Telehealth During the Coronavirus Disease 2019 (COVID-19) Pandemic (NCT04693052), a registered phase not stated study. The primary outcome is Patient Choosing Telehealth as an Option for Future Care.

2. Clinical Question

The study concerns patients receiving mental health care before and during the COVID-19 pandemic. Its central question is whether these patients would choose telehealth as an option for future care. The registry describes telehealth appointments as including phone and video calls and frames the work as collecting patient experiences and feedback.

The question is about stated preference, not whether telehealth changed symptoms, improved care, or was used subsequently. The registry’s description connects the study to ongoing telehealth appointments during the pandemic, including phone and video visits. However, the primary endpoint is specifically a choice about a future-care option, not a measure of clinical benefit or actual future appointment use. The registry record does not report a comparative estimate that would answer whether preferences differed between comparable groups.

3. Trial Design

The registry lists this study as completed, with Northwestern University as sponsor. The record gives a start date of 2020-12-10 and a primary completion date of 2021-01-31. Enrollment is listed as 605, but the registry record does not say how many participants contributed data to the primary outcome or to any analysis.

No intervention is listed. The described participant group consists of patients receiving mental health care prior to and during the COVID-19 pandemic. Although the registry contains an arm description, it does not present a randomized treatment comparison. Allocation is not stated, and the record specifically cautions that the arms are not a like-for-like control comparison. The design therefore does not support interpreting the record as a randomized contrast between telehealth and another care approach.

The stated purpose is to collect patient experiences and feedback to better understand and improve mental health care using telehealth. The registry identifies five outcome measures, while the analysis count is zero. It does not report the recruitment method, eligibility criteria, survey instrument, method of administering questions, or participant-level analysis population. These details are not reported in the registry record.

The primary outcome is assessed at baseline and concerns choosing telehealth or not choosing it for future care, with uncertainty represented by an unsure response. The registry does not describe a treatment allocation procedure, an assigned intervention, or a comparator group suitable for causal inference. The completed status and enrollment entry describe the administrative record, but do not by themselves establish which participants posted outcome data or whether the recorded endpoint was analyzed.

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.

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as Patient Choosing Telehealth as an Option for Future Care, measured over At baseline.

The primary endpoint is titled “Patient Choosing Telehealth as an Option for Future Care.” It is measured at baseline and expressed as a count of participants. Its description distinguishes participants who choose telehealth from those who do not and those who are unsure. The registry does not report an outcome count for any of these response categories.

The endpoint is relevant to the study’s stated aim because it captures a patient preference about telehealth as an option for future mental health care. A count can communicate how many participants fall into each response category, but counts are meaningful only with their denominators and the way responses were collected. The registry record does not report category denominators, proportions, or an analysis of the responses. The enrollment entry is not a substitute for an outcome denominator: the number enrolled need not equal the number with a recorded answer.

In general, stated preference and actual care use are different outcomes. A response about future care does not establish whether a participant later used telehealth, whether that care was accessible or acceptable in practice, or whether it affected a clinical outcome. The endpoint should therefore be read narrowly as a measure of reported choice at baseline. The registry record does not describe how an unsure response was handled in analysis or whether the question had additional response options.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a count of participants and classifies the outcome as binary. Its response description, however, refers to choosing telehealth, not choosing it, or being unsure. No statistical analysis is recorded, so the registry does not explain how those response options were represented in an analysis. In particular, it does not say whether uncertainty was retained as a separate category, combined with another response, or excluded. Those choices affect the meaning of any resulting estimate.

What does a participant count tell us?

In general, a count is the number of observations assigned to a category. A count alone does not show how common a response was unless its denominator is also known. For a preference outcome, the denominator should correspond to participants whose responses were eligible for that calculation, rather than automatically being the enrollment figure. If some participants did not answer, the number and handling of those missing responses matter. The registry record does not report category counts, denominators, or missing-response handling.

In general, binary outcomes are often described using counts and proportions, with an uncertainty interval around an estimated proportion or contrast. The statistical model and target quantity depend on the study design and the question being asked. Here, the endpoint wording includes an unsure response, and the registry does not identify a single analysis method or target contrast. No estimate or uncertainty interval is reported, so there is no basis for describing the precision of a preference estimate.

Why does the comparison structure matter?

In general, a comparison is most interpretable when its groups differ in the exposure of interest but are otherwise appropriate for the target question. Random assignment can support causal interpretation by balancing factors on average, subject to the conduct and analysis of the trial. The registry does not describe a randomized comparison: allocation is not stated, and its note says the arms are not a like-for-like control comparison. This means the record does not support a causal estimate comparing care approaches. It also gives no covariate-adjusted analysis that might address measured differences between groups.

In general, statistical adjustment can account for measured characteristics under specified assumptions, but it cannot guarantee removal of bias from unmeasured or poorly measured differences. An adjusted estimate would also need a clearly defined outcome, comparison, analysis population, and model. No analysis is reported in the registry record, and no adjustment strategy is described. It would therefore be inappropriate to attribute an unreported method to the study.

How should uncertainty and significance be read?

In general, a confidence interval gives a range of values compatible with the data and the model at the stated confidence level. Its width reflects statistical precision, while its position relative to a meaningful reference value can help readers interpret the estimate. A confidence interval does not correct weaknesses in study design, measurement, or missing data. No confidence interval is reported for the primary endpoint.

In general, a significance test evaluates data relative to a specified null hypothesis and model. A p-value is not the probability that the null hypothesis is true, and it does not express the size or importance of an effect. Interpretation requires the estimate, its uncertainty, the hypothesis being tested, and the context of the analysis. The registry record reports no p-value or test for this endpoint.

What are the planning assumptions?

The registry’s planning assumptions describe an illustration, not the study’s own design justification. The illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It is based on a stated fraction of an observed effect. The record does not report the observed effect or a sample-size justification, so the underlying effect magnitude and its relevance to this study cannot be assessed from the registry.

In general, a planning calculation estimates the sample size needed under specified assumptions about the effect, variability, allocation, and statistical procedure. Changing those assumptions changes the planning result. A planning figure is not an observed result and is not “observed power.” It does not show that the enrolled study had a particular probability of detecting an effect, nor does it replace an analysis of collected outcomes. The planning illustrations should be read only as conditional calculations under their stated assumptions.

In general, over-dispersion matters when count data vary more than a model assumes; failing to account for it can make uncertainty appear too small. That concern is not directly established by the primary endpoint as described, which counts participants in response categories rather than reporting a repeated-event count. The registry does not report a model, dispersion assessment, or evidence that an over-dispersed count model was used. No such method should be inferred.

Finally, an unadjusted recalculation from posted summary statistics, where available, is not the same as the sponsor’s analysis. The registry reports no analysis and no estimates for this endpoint, so no recalculated result can be interpreted from this record. Where a recalculation conflicts with a sponsor analysis, the sponsor’s own analysis takes precedence; no discrepancy is reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures but reports zero analyses. It does not describe a procedure for handling multiple outcomes or multiple statistical tests. Multiplicity can arise when several outcomes, response contrasts, subgroups, or time points are examined. In general, testing more hypotheses can increase the chance of finding an apparently notable result by chance, so a plan may define a primary outcome and specify how other tests will be interpreted. The registry identifies a primary outcome but does not report a multiplicity strategy.

Missing-data information is not reported in the registry record. There is no account of how many participants answered the primary question, whether any responses were incomplete, why data might be missing, or how missing responses were treated. In general, missingness can affect both the denominator and the interpretation of an estimate. Excluding unanswered records, treating them as a response category, or using an imputation method would each require an explicit rationale and suitable assumptions. No such approach is described.

The analysis population is also not reported. Enrollment is listed as 605, but the record does not say whether the outcome analysis used all enrolled participants, only those with a recorded response, or another defined group. The record does not state whether exclusions were made or how they were handled. Without this information, readers cannot assess how closely any outcome summary would represent the enrolled participants.

In general, transparent reporting of outcome definitions, missingness, analysis populations, and multiplicity procedures helps readers understand what an estimate represents and how much confidence to place in it. These details are not reported in the registry record, and the absence of recorded analyses means there is no reported inferential result to evaluate.

11. What the Result Does, and Does Not, Mean

The record establishes that the study was intended to gather patient experiences and feedback about mental health care using telehealth during the COVID-19 pandemic. It identifies a baseline preference outcome concerning whether participants chose telehealth as an option for future care. It does not report the response counts or an analysis of those responses. No conclusion about how common a preference was, or how precisely it was estimated, can be drawn from the registry record.

The endpoint is about stated preference. In general, a stated intention is not the same as later behavior. Choosing telehealth as an option does not establish that a participant subsequently received a phone or video appointment, and uncertainty or rejection of telehealth does not establish what care the participant actually received. The endpoint also does not measure symptom change, quality of care, access, or clinical benefit.

The record does not describe a randomized comparison or a like-for-like control group. Therefore, it cannot be used to claim that telehealth caused a preference, changed patient attitudes, or improved mental health care. The study’s purpose and context do not substitute for a comparative analysis. No treatment-effect estimate is reported.

The enrollment entry of 605 should not be interpreted as the number with complete outcome data or as a denominator for a response percentage. The registry does not report those details. Likewise, the zero counts in listed adverse-event categories do not establish that all possible adverse events were actively assessed or absent. They are registry entries without accompanying information about collection or completeness.

In general, registry descriptions help clarify what investigators intended to measure, while outcome analyses are needed to assess what the collected data show. For this record, the distinction is important: the endpoint and study purpose are described, but the primary outcome results and statistical analyses are not reported. The evidence in the registry is consequently descriptive of the planned question, not an answer to it.

12. Why This Trial Matters Statistically

Patient preference is a meaningful statistical outcome when the research question concerns whether a care option is acceptable or desirable to patients. The endpoint focuses on a choice about telehealth for future mental health care, making it distinct from measures of symptom severity or service use. Keeping those constructs separate helps prevent a preference result from being interpreted as evidence about clinical outcomes or actual access.

The record also illustrates why outcome definitions and denominators matter. A count of participants choosing telehealth needs context about the number who answered and how uncertain or missing responses were handled. Without those details, a count cannot be converted into a reliable statement about the distribution of preferences. Enrollment alone does not supply the necessary outcome denominator.

Study design matters just as much as the endpoint. The registry does not describe a randomized comparison, states that allocation is not stated, and cautions that the arms are not a like-for-like control comparison. These details limit causal interpretations. A preference observed in a participant group may describe that group, but it cannot establish that a particular care approach produced the preference.

The record’s lack of analysis also highlights a distinction between a registered study purpose and interpretable results. Outcome counts, estimates, uncertainty intervals, missing-data procedures, and analysis populations are needed to evaluate what the data say. Planning illustrations cannot replace those results. In general, a transparent account of these elements allows readers to judge both the size of an observed pattern and the precision and limitations of the inference.

These statistical distinctions are especially useful when interpreting research framed around patient feedback. Preferences can inform questions for future research and service planning, but their meaning depends on who responded, how the question was asked, and whether the study design supports the intended comparison. The registry record identifies an important question while leaving those results and analytic details unreported.

13. 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.

A central limitation is that no primary outcome results or analyses are reported in the registry record. There are no response-category counts, denominators, estimates, or uncertainty measures to assess. Although enrollment is listed as 605, the number contributing to the primary endpoint is not reported. The analysis count is zero, so the record cannot support conclusions about the observed distribution of preferences.

The comparison structure is limited for causal interpretation. The registry says the study is not a randomized comparison, does not state allocation, and warns that the arms are not a like-for-like control comparison. No control group suitable for a direct causal contrast is described. No adjustment strategy is reported to address differences between groups.

The primary outcome description identifies choosing telehealth, not choosing it, and being unsure, but the registry does not explain the instrument, question wording beyond the short description, response collection process, or treatment of unsure and missing responses. The study’s recruitment method and eligibility criteria are also not reported. These omissions limit assessment of measurement quality and how broadly the results might apply.

The record lists five outcome measures without reporting a multiplicity procedure, analysis populations, or missing-data methods. It also does not report a sample-size justification or the observed effect underlying the planning illustrations. The registry lists zero counts in adverse-event categories but does not describe monitoring or completeness, limiting what those entries can establish about adverse events. The study dates and completed status do not resolve these reporting gaps.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Attitudes Towards Receiving Mental Health Care Using Telehealth During the Coronavirus Disease 2019 (COVID-19) Pandemic — NCT04693052.
• Registry record last updated 2024-05-16; status last verified 2024-05.
• Results first posted 2024-05-16.
• 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.

17. Record Summary

The registry record describes a completed study sponsored by Northwestern University, with a start date of 2020-12-10 and primary completion date of 2021-01-31. Enrollment is listed as 605. The stated purpose is to collect patient experiences and feedback about mental health care using telehealth during the COVID-19 pandemic.

No intervention is listed. The described group consists of patients receiving mental health care prior to and during the pandemic. The primary outcome, assessed at baseline, concerns choosing telehealth as an option for future care and is recorded as a count of participants. The registry lists five outcome measures and zero analyses.

No primary outcome counts, effect estimates, confidence intervals, p-values, analysis population, or missing-data methods are reported in the registry record. The record does not identify a randomized comparison; allocation is not stated, and the described arms are not a like-for-like control comparison. The entry therefore describes the study question and design limitations but does not provide an analyzed answer to the primary question.