Trial Outcomes & Findings for MyNewOptions: An Online Study of Reproductive Life Planning and Contraceptive Action Planning (NCT NCT02100124)
NCT ID: NCT02100124
Last Updated: 2018-07-11
Results Overview
Percentage of surveys with any contraceptive use
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
987 participants
Primary outcome timeframe
24 months
Results posted on
2018-07-11
Participant Flow
Participant milestones
| Measure |
Reproductive Life Planning (RLP)
RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.
Reproductive Life Planning (RLP)
Contraception information
|
Reproductive Life Planning Plus (RLP+)
RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.
Reproductive Life Planning (RLP)
Contraceptive Action Planning
Contraception information
|
Information-only Control
The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.
Contraception information
|
|---|---|---|---|
|
Overall Study
STARTED
|
329
|
329
|
326
|
|
Overall Study
COMPLETED
|
323
|
318
|
323
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
3
|
Reasons for withdrawal
| Measure |
Reproductive Life Planning (RLP)
RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.
Reproductive Life Planning (RLP)
Contraception information
|
Reproductive Life Planning Plus (RLP+)
RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.
Reproductive Life Planning (RLP)
Contraceptive Action Planning
Contraception information
|
Information-only Control
The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.
Contraception information
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
MyNewOptions: An Online Study of Reproductive Life Planning and Contraceptive Action Planning
Baseline characteristics by cohort
| Measure |
Reproductive Life Planning (RLP)
n=329 Participants
RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.
Reproductive Life Planning (RLP)
Contraception information
|
Reproductive Life Planning Plus (RLP+)
n=329 Participants
RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.
Reproductive Life Planning (RLP)
Contraceptive Action Planning
Contraception information
|
Information-only Control
n=326 Participants
The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.
Contraception information
|
Total
n=984 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
329 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
984 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
27.02 years
STANDARD_DEVIATION 5.95 • n=5 Participants
|
27.08 years
STANDARD_DEVIATION 6.13 • n=7 Participants
|
27.28 years
STANDARD_DEVIATION 5.92 • n=5 Participants
|
27.13 years
STANDARD_DEVIATION 5.99 • n=4 Participants
|
|
Sex: Female, Male
Female
|
329 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
984 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
329 participants
n=5 Participants
|
329 participants
n=7 Participants
|
326 participants
n=5 Participants
|
984 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPercentage of surveys with any contraceptive use
Outcome measures
| Measure |
Reproductive Life Planning (RLP)
n=308 Participants
RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.
Reproductive Life Planning (RLP)
Contraception information
|
Reproductive Life Planning Plus (RLP+)
n=298 Participants
RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.
Reproductive Life Planning (RLP)
Contraceptive Action Planning
Contraception information
|
Information-only Control
n=312 Participants
The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.
Contraception information
|
|---|---|---|---|
|
Contraceptive Use
|
93.43 percentage of surveys
Standard Deviation 20.59
|
94.46 percentage of surveys
Standard Deviation 20.53
|
94.10 percentage of surveys
Standard Deviation 19.80
|
SECONDARY outcome
Timeframe: 24 monthsPercentage of surveys where most effective contraceptive method used
Outcome measures
| Measure |
Reproductive Life Planning (RLP)
n=308 Participants
RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.
Reproductive Life Planning (RLP)
Contraception information
|
Reproductive Life Planning Plus (RLP+)
n=298 Participants
RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.
Reproductive Life Planning (RLP)
Contraceptive Action Planning
Contraception information
|
Information-only Control
n=312 Participants
The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.
Contraception information
|
|---|---|---|---|
|
Effectiveness of Contraceptive Method
|
60.66 percentage of surveys
Standard Deviation 45.11
|
63.93 percentage of surveys
Standard Deviation 43.91
|
63.19 percentage of surveys
Standard Deviation 43.22
|
SECONDARY outcome
Timeframe: 24 monthspercentage of surveys where very satisfied with contraceptive method
Outcome measures
| Measure |
Reproductive Life Planning (RLP)
n=299 Participants
RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.
Reproductive Life Planning (RLP)
Contraception information
|
Reproductive Life Planning Plus (RLP+)
n=289 Participants
RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.
Reproductive Life Planning (RLP)
Contraceptive Action Planning
Contraception information
|
Information-only Control
n=304 Participants
The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.
Contraception information
|
|---|---|---|---|
|
Contraceptive Method Satisfaction
|
58.22 percentage of surveys
Standard Deviation 39.39
|
57.09 percentage of surveys
Standard Deviation 41.13
|
57.70 percentage of surveys
Standard Deviation 39.57
|
SECONDARY outcome
Timeframe: 24 monthsPercentage of surveys where contraceptive adherence was high
Outcome measures
| Measure |
Reproductive Life Planning (RLP)
n=299 Participants
RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.
Reproductive Life Planning (RLP)
Contraception information
|
Reproductive Life Planning Plus (RLP+)
n=289 Participants
RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.
Reproductive Life Planning (RLP)
Contraceptive Action Planning
Contraception information
|
Information-only Control
n=304 Participants
The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.
Contraception information
|
|---|---|---|---|
|
Contraceptive Adherence
|
74.02 percentage of surveys
Standard Deviation 34.19
|
73.27 percentage of surveys
Standard Deviation 35.54
|
76.37 percentage of surveys
Standard Deviation 32.69
|
Adverse Events
Reproductive Life Planning (RLP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reproductive Life Planning Plus (RLP+)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Information-only Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place