MedDataX Logo

Trial Outcomes & Findings for Decisional Capacity and Informed Consent in Fragile X Syndrome (NCT NCT02465931)

NCT ID: NCT02465931

Last Updated: 2019-03-07

Results Overview

MacArthur Decisional Capacity - understanding score, range 0 (no understanding) to 26 (perfect understanding) A summary score was calculated, ranging from 0-26. Scores were then translated into a percentage based on the number of questions answered. A score of 100% indicates that the participant answered each understanding question correctly on the first attempt.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

152 participants

Primary outcome timeframe

Day 1, immediately following presentation of the material in the intervention or comparison condition

Results posted on

2019-03-07

Participant Flow

Participants were recruited through research registries and convenience samples

41 participants were excluded because they did not meet eligibility criteria

Participant milestones

Participant milestones
Measure
Intervention Condition
Digital informed consent tool
Comparison Condition
Paper and pencil informed consent
Overall Study
STARTED
55
56
Overall Study
COMPLETED
44
45
Overall Study
NOT COMPLETED
11
11

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention Condition
Digital informed consent tool
Comparison Condition
Paper and pencil informed consent
Overall Study
Lost to Follow-up
9
11
Overall Study
Protocol Violation
1
0
Overall Study
Withdrawal by Subject
1
0

Baseline Characteristics

Decisional Capacity and Informed Consent in Fragile X Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Condition
n=44 Participants
Digital informed consent tool
Comparison Condition
n=45 Participants
Paper and pencil informed consent
Total
n=89 Participants
Total of all reporting groups
Age, Categorical
<=18 years
17 Participants
n=5 Participants
18 Participants
n=7 Participants
35 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
27 Participants
n=5 Participants
27 Participants
n=7 Participants
54 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
21.16 years
STANDARD_DEVIATION 7.11 • n=5 Participants
21.27 years
STANDARD_DEVIATION 7.50 • n=7 Participants
21.21 years
STANDARD_DEVIATION 7.27 • n=5 Participants
Sex: Female, Male
Female
27 Participants
n=5 Participants
25 Participants
n=7 Participants
52 Participants
n=5 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
20 Participants
n=7 Participants
37 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
43 Participants
n=5 Participants
44 Participants
n=7 Participants
87 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
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
White
38 Participants
n=5 Participants
40 Participants
n=7 Participants
78 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Region of Enrollment
United States
44 participants
n=5 Participants
45 participants
n=7 Participants
89 participants
n=5 Participants
Stanford Binet 5 verbal IQ (intelligence quotient) score
65.67 scores on a scale
STANDARD_DEVIATION 17.26 • n=5 Participants
69.48 scores on a scale
STANDARD_DEVIATION 16.37 • n=7 Participants
68.2 scores on a scale
STANDARD_DEVIATION 17.8 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1, immediately following presentation of the material in the intervention or comparison condition

MacArthur Decisional Capacity - understanding score, range 0 (no understanding) to 26 (perfect understanding) A summary score was calculated, ranging from 0-26. Scores were then translated into a percentage based on the number of questions answered. A score of 100% indicates that the participant answered each understanding question correctly on the first attempt.

Outcome measures

Outcome measures
Measure
Intervention Condition
n=44 Participants
Digital informed consent tool
Comparison Condition
n=45 Participants
Paper and pencil informed consent
Decisional Capacity - Understanding Score
74.4 percentage of understanding
Standard Deviation 27.3
75.1 percentage of understanding
Standard Deviation 25.9

Adverse Events

Intervention Condition

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Comparison Condition

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Don Bailey

RTI International

Phone: (919) 541-6488

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place