Trial Outcomes & Findings for Reliability and Equivalence of Alternate Forms of the Digital Clock Drawing Test (NCT NCT04496752)
NCT ID: NCT04496752
Last Updated: 2025-03-07
Results Overview
Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of agreement with MMSE.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
5 weeks
Results posted on
2025-03-07
Participant Flow
Participants were recruited by referral from neurology clinics at 2 study sites. The first participant was enrolled in December 2020, and the last participant was enrolled in May 2021.
Screening for inclusion criteria was conducted at the first study session after enrollment and prior to randomization. Of 200 enrolled participants, 195 met inclusion criteria and were randomized to groups.
Participant milestones
| Measure |
DCTclock-pen First
DCTclock-pen followed by DCTclock-tablet
DCTclock: Cognitive Test
|
DCTclock-tablet First
DCTclock-tablet followed by DCTclock-pen
DCTclock: Cognitive Test
|
|---|---|---|
|
First Assessment
STARTED
|
97
|
98
|
|
First Assessment
COMPLETED
|
97
|
98
|
|
First Assessment
NOT COMPLETED
|
0
|
0
|
|
Second Assessment
STARTED
|
97
|
98
|
|
Second Assessment
Second Visit Begun
|
92
|
95
|
|
Second Assessment
COMPLETED
|
92
|
95
|
|
Second Assessment
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
DCTclock-pen First
DCTclock-pen followed by DCTclock-tablet
DCTclock: Cognitive Test
|
DCTclock-tablet First
DCTclock-tablet followed by DCTclock-pen
DCTclock: Cognitive Test
|
|---|---|---|
|
Second Assessment
Lost to Follow-up
|
3
|
3
|
|
Second Assessment
Adverse Event
|
2
|
0
|
Baseline Characteristics
Reliability and Equivalence of Alternate Forms of the Digital Clock Drawing Test
Baseline characteristics by cohort
| Measure |
DCTclock-pen First
n=97 Participants
DCTclock-pen followed by DCTclock-tablet
DCTclock: Cognitive Test
|
DCTclock-tablet First
n=98 Participants
DCTclock-tablet followed by DCTclock-pen
DCTclock: Cognitive Test
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Handedness
Left
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Handedness
Right
|
88 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Handedness
Ambidextrous
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
Less than High School
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
High School Degree
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Education
Some College
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Education
College Degree or Higher
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Dementia Medication Usage
Aricept (Donepezil) · Currently
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Dementia Medication Usage
Aricept (Donepezil) · Previously
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Dementia Medication Usage
Aricept (Donepezil) · Never
|
91 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Dementia Medication Usage
Namenda (Mematine) · Currently
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Dementia Medication Usage
Namenda (Mematine) · Previously
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Dementia Medication Usage
Namenda (Mematine) · Never
|
92 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Dementia Medication Usage
Axona · Currently
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Dementia Medication Usage
Axona · Previously
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Dementia Medication Usage
Axona · Never
|
97 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Dementia Medication Usage
Exelon (Rivastigmine) · Currently
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Dementia Medication Usage
Exelon (Rivastigmine) · Previously
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Dementia Medication Usage
Exelon (Rivastigmine) · Never
|
95 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Dementia Medication Usage
Razadyne (Galantamine) · Currently
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Dementia Medication Usage
Razadyne (Galantamine) · Previously
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Dementia Medication Usage
Razadyne (Galantamine) · Never
|
97 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Orientation to Time
|
4.8 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Orientation to Place
|
4.4 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Registration
|
3.0 units on a scale
STANDARD_DEVIATION 0.0 • n=5 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.1 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Attention and Calculation (WORLD)
|
4.6 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Recall
|
2.6 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Naming
|
2.0 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.0 • n=7 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Repetition
|
0.8 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
0.8 units on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
0.8 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Comprehension
|
3.0 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 0.3 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Reading
|
1.0 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
|
1.0 units on a scale
STANDARD_DEVIATION 0.0 • n=7 Participants
|
1.0 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Writing
|
1.0 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
|
1.0 units on a scale
STANDARD_DEVIATION 0.1 • n=7 Participants
|
1.0 units on a scale
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Drawing
|
0.8 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
0.8 units on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
0.8 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Mini-Mental State Exam (MMSE) Score
Total
|
27.9 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
27.9 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
27.9 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Hamilton-Veale Contrast Sensitivity Score
Left
|
10.6 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
10.7 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
10.7 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Hamilton-Veale Contrast Sensitivity Score
Right
|
10.6 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
10.6 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
10.6 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Hamilton-Veale Contrast Sensitivity Score
Binocular
|
11.4 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
11.6 units on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Purdue Pegboard Score
Left
|
10.3 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Purdue Pegboard Score
Right
|
11.0 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Purdue Pegboard Score
Both Hands
|
10.7 units on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
|
11.7 units on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Medical History
Parkinson's Disease and Related Conditions · Currently
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medical History
Parkinson's Disease and Related Conditions · Previously
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Medical History
Parkinson's Disease and Related Conditions · Never
|
96 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Medical History
Sleep Apnea · Currently
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Medical History
Sleep Apnea · Previously
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Medical History
Sleep Apnea · Never
|
87 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Medical History
Stroke or TIA · Currently
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medical History
Stroke or TIA · Previously
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Medical History
Stroke or TIA · Never
|
91 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Medical History
Liver or Kidney Disease · Currently
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Medical History
Liver or Kidney Disease · Previously
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medical History
Liver or Kidney Disease · Never
|
92 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Medical History
Tremor · Currently
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Medical History
Tremor · Previously
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Medical History
Tremor · Never
|
95 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Medical History
Brain Tumor · Currently
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medical History
Brain Tumor · Previously
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medical History
Brain Tumor · Never
|
96 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Medical History
Psychiatric Disorder (including Anxiety/Depression) · Currently
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Medical History
Psychiatric Disorder (including Anxiety/Depression) · Previously
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Medical History
Psychiatric Disorder (including Anxiety/Depression) · Never
|
79 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Medical History
Dementia (any type) · Currently
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Medical History
Dementia (any type) · Previously
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medical History
Dementia (any type) · Never
|
94 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Medical History
Diabetes · Currently
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Medical History
Diabetes · Previously
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medical History
Diabetes · Never
|
64 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Medical History
Mild Cognitive Impairment (MCI) · Currently
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Medical History
Mild Cognitive Impairment (MCI) · Previously
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Medical History
Mild Cognitive Impairment (MCI) · Never
|
97 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Medical History
Traumatic brain injury (with loss of consciousness) · Currently
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medical History
Traumatic brain injury (with loss of consciousness) · Previously
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Medical History
Traumatic brain injury (with loss of consciousness) · Never
|
92 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: Analysis includes only assessments from participants who: (1) completed both assessment sessions; and (2) produced clocks from both assessments which could be analyzed to give a valid score. Of participants who completed both sessions, 170 of 187 produced two analyzable clocks and were included in analysis (84 of 92 in the pen-first group, and 86 of 95 in the tablet-first group).
Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of agreement with MMSE.
Outcome measures
| Measure |
DCTClock-pen
n=170 Assessments
Assessments with the DCTClock-pen format, from participants who completed assessments with both DCTClock-pen and DCTClock-tablet.
Assessments from participants who failed to complete either of the formats, due to protocol deviations and/or technical failure, were excluded.
|
DCTClock-tablet
n=170 Assessments
Assessments with the DCTClock-tablet format, from participants who completed assessments with both DCTClock-pen and DCTClock-tablet.
Assessments from participants who failed to complete either of the formats, due to protocol deviations and/or technical failure, were excluded.
|
|---|---|---|
|
Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment
|
0.16 Cohen's Kappa Coefficient
Interval 0.05 to 0.27
|
0.23 Cohen's Kappa Coefficient
Interval 0.12 to 0.33
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: Analysis includes only assessments from participants who: (1) completed both assessment sessions; and (2) produced clocks from both assessments which could be analyzed to give a valid score. Of participants who completed both sessions, 170 of 187 produced two analyzable clocks and were included in analysis (84 of 92 in the pen-first group, and 86 of 95 in the tablet-first group).
Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of correlation with MMSE.
Outcome measures
| Measure |
DCTClock-pen
n=170 Assessments
Assessments with the DCTClock-pen format, from participants who completed assessments with both DCTClock-pen and DCTClock-tablet.
Assessments from participants who failed to complete either of the formats, due to protocol deviations and/or technical failure, were excluded.
|
DCTClock-tablet
n=170 Assessments
Assessments with the DCTClock-tablet format, from participants who completed assessments with both DCTClock-pen and DCTClock-tablet.
Assessments from participants who failed to complete either of the formats, due to protocol deviations and/or technical failure, were excluded.
|
|---|---|---|
|
Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation)
Pearson Correlation
|
0.31 correlation coefficient
Interval 0.17 to 0.43
|
0.37 correlation coefficient
Interval 0.25 to 0.49
|
|
Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation)
Spearman Correlation
|
0.29 correlation coefficient
Interval 0.17 to 0.41
|
0.36 correlation coefficient
Interval 0.24 to 0.46
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: All participants who passed screening and were enrolled in the study.
Number of serious device-related adverse events. See adverse events section for full reporting of adverse events, including both device-related and non-device related.
Outcome measures
| Measure |
DCTClock-pen
n=97 Participants
Assessments with the DCTClock-pen format, from participants who completed assessments with both DCTClock-pen and DCTClock-tablet.
Assessments from participants who failed to complete either of the formats, due to protocol deviations and/or technical failure, were excluded.
|
DCTClock-tablet
n=98 Participants
Assessments with the DCTClock-tablet format, from participants who completed assessments with both DCTClock-pen and DCTClock-tablet.
Assessments from participants who failed to complete either of the formats, due to protocol deviations and/or technical failure, were excluded.
|
|---|---|---|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
Overall · No Adverse Event
|
90 Participants
|
96 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
During Visit 1 · Device-Related Adverse Event
|
0 Participants
|
0 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
During Visit 1 · Other Adverse Event
|
0 Participants
|
0 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
During Visit 1 · No Adverse Event
|
97 Participants
|
98 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
Between Visits · Device-Related Adverse Event
|
0 Participants
|
0 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
Between Visits · Other Adverse Event
|
7 Participants
|
1 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
Between Visits · No Adverse Event
|
90 Participants
|
97 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
During Visit 2 · Device-Related Adverse Event
|
0 Participants
|
0 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
During Visit 2 · Other Adverse Event
|
0 Participants
|
1 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
During Visit 2 · No Adverse Event
|
97 Participants
|
97 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
Overall · Device-Related Adverse Event
|
0 Participants
|
0 Participants
|
|
Number of Participants With Device-Related and Non-Device Related Adverse Events
Overall · Other Adverse Event
|
7 Participants
|
2 Participants
|
Adverse Events
DCTclock-pen First, DCTclock-pen Visit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DCTclock-tablet First, DCTclock-tablet Visit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DCTclock-pen First, DCTclock-tablet Visit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DCTclock-tablet First, DCTclock-pen Visit
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DCTclock-pen First, Between Visits
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
DCTclock-tablet First, Between Visits
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DCTclock-pen First, DCTclock-pen Visit
n=97 participants at risk
The DCTclock-pen visit for participants who were assessed with the DCTclock-pen in the first visit, and DCTclock-tablet in the second visit (i.e., Visit 1).
|
DCTclock-tablet First, DCTclock-tablet Visit
n=98 participants at risk
The DCTclock-tablet visit for participants who were assessed with the DCTclock-tablet in the first visit, and DCTclock-pen in the second visit (i.e., Visit 1).
|
DCTclock-pen First, DCTclock-tablet Visit
n=97 participants at risk
The DCTclock-tablet visit for participants who were assessed with the DCTclock-pen at the first visit, and the DCTclock-tablet second visit (i.e., Visit 2).
|
DCTclock-tablet First, DCTclock-pen Visit
n=98 participants at risk
The DCTclock-pen visit for participants who were assessed with the DCTclock-tablet at the first visit, and the DCTclock-pen at the second visit (i.e., Visit 2).
|
DCTclock-pen First, Between Visits
n=97 participants at risk
Captures any reported events that occurred between the two study visits, for participants who were assessed with the DCTclock-pen at the first visit, and the DCTclock-tablet at the second visit.
|
DCTclock-tablet First, Between Visits
n=98 participants at risk
Captures any reported events that occurred between the two study visits, for participants who were assessed with the DCTclock-tablet at the first visit, and the DCTclock-pen at the second visit.
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
1.0%
1/97 • Number of events 1 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
|
General disorders
Death
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
1.0%
1/97 • Number of events 1 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
1.0%
1/97 • Number of events 1 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
Other adverse events
| Measure |
DCTclock-pen First, DCTclock-pen Visit
n=97 participants at risk
The DCTclock-pen visit for participants who were assessed with the DCTclock-pen in the first visit, and DCTclock-tablet in the second visit (i.e., Visit 1).
|
DCTclock-tablet First, DCTclock-tablet Visit
n=98 participants at risk
The DCTclock-tablet visit for participants who were assessed with the DCTclock-tablet in the first visit, and DCTclock-pen in the second visit (i.e., Visit 1).
|
DCTclock-pen First, DCTclock-tablet Visit
n=97 participants at risk
The DCTclock-tablet visit for participants who were assessed with the DCTclock-pen at the first visit, and the DCTclock-tablet second visit (i.e., Visit 2).
|
DCTclock-tablet First, DCTclock-pen Visit
n=98 participants at risk
The DCTclock-pen visit for participants who were assessed with the DCTclock-tablet at the first visit, and the DCTclock-pen at the second visit (i.e., Visit 2).
|
DCTclock-pen First, Between Visits
n=97 participants at risk
Captures any reported events that occurred between the two study visits, for participants who were assessed with the DCTclock-pen at the first visit, and the DCTclock-tablet at the second visit.
|
DCTclock-tablet First, Between Visits
n=98 participants at risk
Captures any reported events that occurred between the two study visits, for participants who were assessed with the DCTclock-tablet at the first visit, and the DCTclock-pen at the second visit.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Eye infection
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
1.0%
1/97 • Number of events 1 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
|
Cardiac disorders
Syncope
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
1.0%
1/97 • Number of events 1 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
1.0%
1/97 • Number of events 1 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
|
Injury, poisoning and procedural complications
Covid Vaccine Side Effects
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
1.0%
1/97 • Number of events 1 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
|
General disorders
Vertigo
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
1.0%
1/98 • Number of events 1 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Fracture of Bone
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/98 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
0.00%
0/97 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
1.0%
1/98 • Number of events 1 • Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).
Investigators completed a case report form (CRF), including a structured adverse event report, at each study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place