Trial Outcomes & Findings for Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization (NCT NCT03400449)
NCT ID: NCT03400449
Last Updated: 2019-11-13
Results Overview
Duration of counseling in minutes (from initiation of counseling to conclusion of all questions answered.) The clock was not stopped for breaks, which were allowed as needed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Immediately following the intervention, an average of less than 30 minutes
Results posted on
2019-11-13
Participant Flow
Participant milestones
| Measure |
Video Counseling
The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.
Video counseling: Video counseling
|
Conversational Counseling
The conversation group participated in a structured, face-to-face conversation with a trained counselor.
Conversational counseling: Conversational counseling
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
119
|
|
Overall Study
COMPLETED
|
120
|
119
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Video Counseling
n=120 Participants
The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.
Video counseling: Video counseling
|
Conversational Counseling
n=119 Participants
The conversation group participated in a structured, face-to-face conversation with a trained counselor.
Conversational counseling: Conversational counseling
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=120 Participants
|
23 Participants
n=119 Participants
|
43 Participants
n=239 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=120 Participants
|
96 Participants
n=119 Participants
|
196 Participants
n=239 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=120 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=239 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=120 Participants
|
119 Participants
n=119 Participants
|
239 Participants
n=239 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=120 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=239 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Colombia
|
120 participants
n=120 Participants
|
119 participants
n=119 Participants
|
239 participants
n=239 Participants
|
PRIMARY outcome
Timeframe: Immediately following the intervention, an average of less than 30 minutesDuration of counseling in minutes (from initiation of counseling to conclusion of all questions answered.) The clock was not stopped for breaks, which were allowed as needed.
Outcome measures
| Measure |
Video Counseling
n=120 Participants
The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.
Video counseling: Video counseling
|
Conversational Counseling
n=119 Participants
The conversation group participated in a structured, face-to-face conversation with a trained counselor.
Conversational counseling: Conversational counseling
|
|---|---|---|
|
Total Counseling Time
|
16.8 minutes
Standard Deviation 4.6
|
16.3 minutes
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: One hourMean total correct answer (score) to 7 multiple-choice contraceptive knowledge questions. Total possible score is 0-7, with 7 representing 100% correct answers. Score measured after completion of the knowledge questionnaire, on average less than one hour, before (pre) and after (post) counseling.
Outcome measures
| Measure |
Video Counseling
n=119 Participants
The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.
Video counseling: Video counseling
|
Conversational Counseling
n=120 Participants
The conversation group participated in a structured, face-to-face conversation with a trained counselor.
Conversational counseling: Conversational counseling
|
|---|---|---|
|
Knowledge Scores
Pre-counseling
|
3.1 score on a scale
Standard Deviation 1.5
|
3.1 score on a scale
Standard Deviation 1.5
|
|
Knowledge Scores
Post-counseling
|
5.3 score on a scale
Standard Deviation 1.0
|
5.1 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Assessed at the time of hospital discharge, on average less than 2 daysNumber of participants initiating long-acting reversible contraception (LARC - intrauterine device (IUD) or implant) prior to hospital discharge.
Outcome measures
| Measure |
Video Counseling
n=119 Participants
The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.
Video counseling: Video counseling
|
Conversational Counseling
n=120 Participants
The conversation group participated in a structured, face-to-face conversation with a trained counselor.
Conversational counseling: Conversational counseling
|
|---|---|---|
|
Number of Participants Initiating Postpartum LARC Uptake
|
46 Participants
|
44 Participants
|
Adverse Events
Video Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conversational Counseling
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
Ob/Gyn Regulatory Specialist
Oregon Health & Science University
Phone: 5034940757
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place