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 Remote Access to Care, Everywhere, for Parkinson Disease (NCT02144220), a na na study. The primary outcome is Feasibility.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02144220 |
| Phase | NA |
| Condition | Parkinson Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 277 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Rochester |
| Results posted | Yes |
2. Clinical Question
Population
People with Parkinson disease. The registry record lists enrollment of 277 and describes an aim to evaluate remote care nationally, including care delivered directly into patients’ homes.
Intervention
A virtual care visit, described as a one-time visit for Parkinson disease.
Comparator
There is no like-for-like control group in the registry record. The study is listed as single-group, with allocation recorded as NA.
Primary question
What percentage of telemedicine visits were completed as scheduled during the 6-month timeframe, and did that percentage meet the stated goal of >80%?
The study’s broader objectives were to assess whether remote evaluations could be conducted, examine possible effects of remote care on quality of life and management of Parkinson disease, and assess patients’ long-term acceptability of ongoing telemedicine care. These objectives describe the questions motivating the study; they do not establish that those outcomes were measured or improved. The registry lists acceptability, descriptive feasibility, and the percentage of patients who felt recommendations improved their health as secondary outcomes.
Because this is a single-group study rather than a randomized comparison, its primary question is about feasibility within the study’s care arrangement. It does not directly compare virtual visits with another care approach. The registry record does not report a primary outcome percentage, so the stated goal cannot be assessed from the information recorded.
3. Trial Design
The registry identifies NCT02144220 as a completed study sponsored by the University of Rochester. It lists Parkinson disease as the condition, an enrollment of 277, and a virtual care visit as the intervention. The arm description characterizes the visit as one-time. The study model is single-group; allocation is listed as NA, and masking is listed as none. The record also indicates that this is not a randomized comparison and that its arms should not be treated as like-for-like controls.
The study began in 2014-03, and the primary completion date is listed as 2016-08. Its phase is recorded as NA. The primary outcome is feasibility, defined as the percentage of telemedicine visits completed as scheduled, with a timeframe of 6 months and a stated goal of >80%. This is a process-oriented outcome: it concerns whether scheduled visits took place, rather than a direct comparison of clinical outcomes between care groups.
The study’s stated aims included demonstrating the feasibility of remote evaluations nationally, measuring the impact of remote care on quality of life and disease management, and assessing long-term acceptability. The record lists secondary outcomes for acceptability, descriptive feasibility, and the percentage of patients who felt recommendations improved their health. It also records five outcome measures overall and one analysis, but does not provide the analysis details needed to determine how each measure was handled.
Since there is no comparator group, changes over time or outcomes observed after a virtual visit cannot by themselves distinguish the contribution of the visit from other influences. The registry record does not report a randomized allocation procedure, a masking procedure, or a separate control intervention. The listed design therefore supports a descriptive reading of feasibility and other recorded outcomes, not an estimate of a comparative treatment effect.
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: Individuals indicated their interest in participating by either visiting the Davis Phinney Foundation's "funded research" web page where individuals completed an online screening survey or by contacting study coordinators by phone or email.
Overall Study
| Stage | Virtual Care Visit |
|---|---|
| STARTED | 277 |
| COMPLETED | 258 |
| NOT COMPLETED | 19 |
Reasons for not completing this period:
| Reason | Virtual Care Visit |
|---|---|
| technology incompatibility | 9 |
| Lack of Efficacy | 4 |
| Physician Decision | 3 |
| Withdrawal by Subject | 2 |
| Protocol Violation | 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.
| Characteristic | Unit | Virtual Care Visit |
|---|---|---|
| Participants analysed | 277 | |
| Age, Continuous | years | 67.1 (SD 9.1) |
| Gender: Female | Participants | 138 |
| Gender: Male | Participants | 139 |
| Region of Enrollment: United States | participants | 277 |
6. Primary Endpoint
The registry lists the primary outcome as Feasibility, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of visits |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage of telemedicine visits completed as scheduled. Its timeframe is 6 months, and the registry states a goal of >80%. This outcome measures operational feasibility: whether the planned remote visits could be carried out as arranged. It is not itself a measure of symptom change, quality of life, or disease control.
A percentage for this endpoint requires a defined numerator—the scheduled visits completed—and denominator—the visits counted as scheduled or otherwise eligible for assessment. The registry record does not report either count or the resulting percentage. Enrollment of 277 is not necessarily the endpoint denominator: the outcome is expressed as a percentage of visits, while enrollment counts people in the study. The registry does not explain how repeated, rescheduled, or missed visits were classified.
In general, a feasibility measure can help characterize whether a care-delivery process is workable under the conditions studied. The stated goal gives a benchmark for interpretation, but the benchmark alone is not an observed result. Without the reported completion percentage and its underlying visit counts, it is not possible to determine from the registry record whether the goal was met or how precisely the completion rate was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies feasibility as the primary outcome and defines it as the percentage of visits completed as scheduled. It also gives a 6-month timeframe and a goal of >80%. However, it does not report the observed percentage, the completed-visit count, or the number of visits used as the denominator. The primary feasibility result therefore cannot be evaluated from the registry record. In particular, the stated goal should not be mistaken for an achieved result.
The study is listed as single-group, with no randomized comparison. That design can describe whether the virtual-visit process was carried out among the study participants, if the relevant outcome data are reported. It cannot establish how feasibility would compare with another care model, because the registry does not identify a like-for-like control group. The same caution applies to interpreting any changes in quality of life or disease management: the stated aims do not provide outcome estimates or establish that any change was caused by remote care.
The record lists an enrollment of 277 and a completed status. Those details describe study registration and completion status, not the number of visits completed or the amount of outcome data available. Enrollment should not be used as a substitute denominator for a visit-level endpoint. Nor does the completed status establish that every planned visit occurred or that every outcome was assessed.
The registry lists acceptability, descriptive feasibility, and patients’ views on whether recommendations improved their health among secondary outcomes. It does not report results for those outcomes in the record used for this analysis. Thus, the stated objective of assessing acceptability and the presence of named secondary outcomes cannot be taken as evidence of a particular level of acceptability or perceived benefit.
The adverse-event fields list zero affected for serious events and zero affected for other events, with 277 at risk in each listed category. The record does not provide event terms, further context about ascertainment, or a death count. These fields should be read as registry entries, not as a complete account of every possible safety concern or proof that no event occurred outside the recorded categories.
Overall, the available record supports a description of the study’s purpose, single-group design, and planned feasibility measure. It does not contain the primary outcome estimate or enough analytical detail to assess its precision. Interpretation should therefore remain focused on what was registered, while treating claims about feasibility, clinical impact, and acceptability as unresolved in this record.
9. Statistical Methods Explained
The registry record presents a single-group study of a virtual care visit. General statistical interpretation of this design begins by separating description from comparison. A single-group analysis can describe outcomes observed among the group studied, but without a concurrent comparator it does not estimate the difference between virtual care and another care approach. The record explicitly cautions that the study is not a randomized comparison.
What does a percentage-of-visits endpoint represent?
In general, a percentage is a ratio of a counted event to a defined total. For this endpoint, the event is a telemedicine visit completed as scheduled, and the outcome is expressed as a percentage of visits. Interpretation depends on how the registry or study defines a scheduled visit, a completed visit, and the set of visits included in the denominator. A missed visit, a rescheduled visit, or a visit that could not be assessed may be handled differently under different rules. The registry record does not report those rules or the underlying counts.
The unit matters. A visit-level percentage is not automatically a percentage of participants. A participant could have more than one visit, but the record does not state whether that occurred or how visits were counted. Enrollment of 277 refers to study enrollment; it cannot be assumed to be the denominator for a measure defined as a percentage of visits. Without the visit counts, neither the observed rate nor its statistical uncertainty can be reconstructed.
How should the stated goal be used?
The goal is >80%. In general, a benchmark can help frame whether an observed process rate would be considered adequate for a study’s purpose. It is not a result, and it does not show that the rate was achieved. To compare an observed rate with a benchmark, readers need the reported estimate and, for a fuller assessment, information about its precision. The registry record does not report the primary estimate or an interval around it.
What would a confidence interval add?
In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the statistical method used. For a visit-completion percentage, it can help readers distinguish a precisely estimated rate from an estimate with substantial uncertainty. Its interpretation depends on the analysis unit and the way observations are related. If visits from the same participant are correlated, treating every visit as independent may understate uncertainty. The registry record does not describe the number of visits per participant, the statistical method, or an interval estimate, so no precision assessment can be made.
Why can over-dispersion matter?
In general, over-dispersion arises when observed variability is greater than a model assumes. For counts or proportions, ignoring extra variability can make uncertainty appear smaller than it is. Clustering, repeated observations, or variation across settings can contribute to this issue, depending on the study and analysis. These are general statistical considerations, not claims about this study: the registry does not report an analysis model, clustering structure, or evidence of over-dispersion.
What do the planning assumptions mean?
The registry’s sample-size assumptions describe a planning illustration based on an observed effect, not the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect stated as a fraction of the observed effect. Time-to-event planning is described in terms of total events; other planning is described in terms of participants per arm. Those assumptions are hypothetical planning conventions. They do not change the registered single-group design, establish that the trial used two arms, or demonstrate that a planned sample size was achieved. Sample-size illustrations are planning aids, not observed power.
The registry record does not report the statistical method used for the primary endpoint, the definition of the analysis population, or a confidence interval. It also does not report a sample-size justification for the actual study design. Without those details, a reader should not infer a particular model, test, adjustment, or precision estimate from the outcome definition alone.
10. Multiplicity, Missing Data and Analysis Populations
The record lists five outcome measures overall, identifies acceptability, descriptive feasibility, and the percentage of patients who felt recommendations improved their health as secondary outcomes, and records one analysis. The primary outcome is feasibility. These entries show that more than one outcome was part of the study record, but they do not explain how the outcomes were prioritized or how statistical testing was organized.
Multiplicity concerns arise in general when several outcomes or statistical tests are examined: the chance of finding an apparently notable result can increase if many tests are conducted. Whether and how to address this depends on the study questions and analysis plan. The registry record does not report a multiplicity adjustment, a prespecified hierarchy among secondary outcomes, or the details of the one listed analysis. No adjustment or testing strategy should therefore be assumed.
Missing-data methods are also not reported in the registry record. It does not state how incomplete visit information, missed visits, unavailable questionnaire responses, or other missing outcome data were handled. For a visit-completion endpoint, the rules for including visits in the denominator are important: excluding visits with unknown status could produce a different estimate from counting them as not completed. The registry record does not specify such rules.
The analysis population is not reported in the registry record. The enrollment figure alone does not establish how many participants or visits contributed to each outcome. The record also does not describe exclusions, withdrawals, or whether every enrolled participant was assessed. These omissions limit assessment of potential selection effects and make it difficult to connect enrollment with outcome denominators.
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 |
|---|---|---|---|
| Virtual Care Visit | 0 | 277 | 0.0% |
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 |
|---|---|
| Virtual Care Visit | 0 of 277 |
The registry lists a Virtual Care Visit group with 277 at risk for serious adverse events and 0 affected. It also lists 277 at risk for other adverse events and 0 affected. These are the recorded figures for the categories shown; they do not provide a complete account of event timing, severity beyond the category, or relationship to the intervention.
Zero affected in the registry fields should be read as a reported count, not as proof that no health event occurred or that every potential event was captured. The record does not list serious adverse-event terms, and deaths are not reported in the registry record. It also does not describe the method or duration of safety surveillance. The 6-month timeframe belongs to the primary feasibility outcome; the record does not establish that the same timeframe applies to the adverse-event fields.
In general, safety counts are most informative when their definitions, observation period, and ascertainment procedures are clear. The available entries do not provide those details. They can be described accurately as zero affected in each listed category, but they should not be expanded into a broader claim about safety or used to compare risks with another care approach.
12. What the Result Does, and Does Not, Mean
The record establishes that this was a completed, single-group study of a one-time virtual care visit for people with Parkinson disease. Its primary endpoint was the percentage of telemedicine visits completed as scheduled over a 6-month timeframe, with a stated goal of >80%. The record also describes broader aims concerning feasibility, quality of life, disease management, and long-term acceptability.
What the record does not establish is whether the feasibility goal was reached. No observed completion percentage or visit counts are reported. The enrollment of 277 does not answer that question because the endpoint is defined in terms of visits, not enrolled participants. The stated goal is a target, not evidence of the observed rate.
The design also does not support a direct comparison with another care model. A single-group study can describe recorded experiences and outcomes within its study arrangement, but it cannot separate the influence of virtual care from other possible influences through a randomized contrast. The registry’s aims to assess quality of life, disease management, and acceptability should not be read as findings that those outcomes improved or were accepted.
The adverse-event entries show zero affected in the listed serious and other event categories, with 277 at risk in each. They do not report deaths, event terms, or surveillance details. Those entries are limited registry information, not a complete safety conclusion.
In general, a clinical study result is strongest when its outcome estimate, uncertainty, analysis population, and handling of missing data are transparent. Those details are not reported for the primary outcome in this registry record. The appropriate conclusion is therefore limited: the study was registered to evaluate remote-care feasibility and related outcomes, but the available record does not provide the results needed to judge the primary endpoint or broader clinical effects.
13. Why This Trial Matters Statistically
This study is statistically interesting because its primary question concerns delivery of care rather than a direct contrast between treatments. Feasibility outcomes can help describe whether a process—here, scheduled telemedicine visits—was carried out as intended. Such measures can be relevant when a study is evaluating remote access to care, but their interpretation depends on clear definitions of the unit counted and the denominator.
The endpoint is expressed as a percentage of visits, while enrollment is reported as a count of participants. Keeping these units distinct is essential. A participant count cannot stand in for the number of scheduled visits without information linking participants to visits. The registry record does not give that information or report the primary percentage, making the distinction particularly important when interpreting the stated goal of >80%.
The single-group design also illustrates a core distinction in clinical statistics: describing an outcome is not the same as estimating a comparative effect. Without a like-for-like control group, an observed feasibility rate could characterize the study’s delivery process, but it would not show how that process compares with another approach. Similarly, the study’s stated interest in quality of life and disease management does not, by itself, support a causal claim about those outcomes.
Finally, the record illustrates why results and methods must be read together. A benchmark is not an observed result, and enrollment is not an endpoint denominator. Missing details about the analysis population, uncertainty, and missing data further limit interpretation. These distinctions help readers separate a study’s purpose and design from evidence that its stated objectives were achieved.
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 main limitation for interpreting this trial-specific record is that it does not report the primary feasibility estimate. The registry gives the definition, timeframe, and goal, but no numerator, denominator, percentage, or interval estimate. As a result, the outcome cannot be assessed against the stated goal from this record.
The endpoint is visit-based, whereas enrollment is reported as 277. The registry does not explain how many visits were planned, whether participants could have repeated visits, or how rescheduled, missed, or unassessed visits were classified. It is therefore not possible to determine the relevant analysis denominator or assess whether visit-level observations might be related within participants.
The single-group model and lack of a like-for-like control comparison limit causal and comparative interpretation. The record describes a virtual care visit, but does not provide a basis for estimating how its outcomes differ from another care approach. The aims regarding quality of life, disease management, and acceptability are not accompanied by outcome results in the record.
The registry does not report the primary analysis method, confidence interval, analysis population, handling of missing data, or a multiplicity strategy. It also does not provide further details on adverse-event ascertainment or report deaths. These omissions prevent fuller assessment of precision, selection, and safety reporting. The completed status and enrollment figure do not resolve these limitations or substitute for outcome results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Remote Access to Care, Everywhere, for Parkinson Disease — NCT02144220.
- Registry record last updated 2017-02-23; status last verified 2017-01.
- Results first posted 2017-01-09.
- 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.
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18. Record Summary
NCT02144220, titled “Remote Access to Care, Everywhere, for Parkinson Disease,” is listed as completed and sponsored by the University of Rochester. The registry records a single-group study, allocation NA, no masking, and enrollment of 277. The intervention is a one-time virtual care visit for Parkinson disease.
The primary outcome is feasibility, defined as the percentage of telemedicine visits completed as scheduled over 6 months, with a stated goal of >80%. The record lists secondary outcomes concerning acceptability, descriptive feasibility, and patients’ views on whether recommendations improved their health. It describes broader aims involving remote evaluation, quality of life, disease management, and long-term acceptability.
The primary outcome result and its underlying visit counts are not reported in the registry record. The record lists zero affected for serious and other adverse events, with 277 at risk in each category; deaths are not reported. Because the design is single-group and the analysis details are not reported, the available record supports description of the study plan and registration, but not a comparative estimate or a determination that the feasibility goal was met.