ContraceptionNCT01994005
Randomized Controlled Trial of Adjunctive Social Media for More Effective Contraceptive Counseling
A study testing Facebook and Pamphlet in people with Contraception, run by New York Presbyterian Hospital at 1 site in United States.
Trial summary
The scope of this project was to provide evidence that better contraceptive choices are made with more effective counseling as well as improvement in patients' contraceptive knowledge. Specifically we wanted to evaluate the use of social media as a means for effective patient counseling. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Facebook and Pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years of age
- English speaking
Who cannot join
- <18 or >45 years old
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
The scope of this project was to provide evidence that better contraceptive choices are made with more effective counseling as well as improvement in patients' contraceptive knowledge. Specifically we wanted to evaluate the use of social media as a means for effective patient counseling.
Read the detailed description
This study was performed at an urban obstetrics/gynecology clinic at New York-Presbyterian Hospital-Weill Cornell Medical Center. Institutional review board approval for this trial was obtained from the Weill Cornell Medical Center.
A total of 180 subjects, ages 18-45, were approached for enrollment into this study. Patients were eligible if they were scheduled for a new gynecologic visit, follow-up gynecologic visit, preconception counseling or post-partum visit. Patients who did not speak English or declined participation were ineligible as well as currently pregnant patients; 32 subjects were thus excluded. There were no exclusion criteria outside of age, language, currently pregnant status and willingness to participate. 148 patients met inclusion criteria and were randomized. 4 patients were excluded after randomization: 1 for not disclosing age, 3 for not completing the study (Figure 1). All patients provided written informed consent prior to randomization. Subjects in our population are a well-educated population. In a previous study conducted in the same clinic, 60% of women had some college education and another 29% had high school diploma or GED (unpublished data).
Randomization was achieved through an opaque envelope system. Equal numbers of opaque envelopes contained slips of paper with the number 1 or 2, signifying to the investigators the randomization group of each subject. Subjects were randomized to either standard counseling + pamphlet education (n= 74) or standard counseling + Facebook education (n=70). After randomization and prior to any intervention, a validated contraceptive knowledge survey (Contraceptive Knowledge Inventory, CKI)10 was administered to the subjects. The survey contained 25 questions specifically addressing general contraceptive knowledge and risks/benefits associated with different contraceptive methods. The subjects had unlimited time to complete the pre-intervention survey. Patients were also questioned about demographic information, including gravidity, marital status, age, and race/ethnicity, and their currently used contraceptive, including no contraceptive. A single provider then provided standardized counseling for all subjects involved in the study, which was conducted one-on-one. Standard counseling included discussion of barrier, hormonal, surgical and implantable/intrauterine devices. 15 minutes was allocated per patient for standard counseling in both groups. The goal of the standard counseling was to simulate a 15-minute in-office consultation specifically addressing contraception. Only American Congress of Obstetricians and Gynecologists (ACOG) derived facts were used, and a transcript was followed by the single provider, who was an M.D., to guarantee uniformity. The ACOG pamphlets were chosen for content pertaining to the CKI. Once the pamphlets were chosen, the Facebook page was constructed to be identical in content to the ACOG pamphlets.
Depending on the randomization group, patients were given 30 minutes to review ACOG patient education pamphlets specifically addressing contraception, or to interact with a Facebook page created by the investigators using identical content but in video, diagram and game format. The pamphlets were accessed on the ACOG website under patient education (www.acog.org). Following the intervention phase of the project, the subjects were administered the CKI again to assess post-intervention knowledge. At the completion of the post-intervention CKI, subjects were questioned regarding their preference for contraception and satisfaction with their counseling method. Subject satisfaction was measured in a similar fashion as clinical pain control. A 1-10 scale was used with 5 being neutral (i.e. the subject did not feel the method improves or negatively effects their counseling). A score of less than 5 was dissatisfaction with the counseling method and a score of greater than 5 signified satisfaction. 10 was a perfect score and meant the subject felt the intervention provided a significant improvement in counseling method.
- Conditions
- Contraception
- Being tested
- Facebook, Pamphlet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FacebookBehavioural
Facebook page with contraception information used for counseling
PamphletBehavioural
Contraceptive knowledge pamphlets
| Study group | Role | What they receive |
|---|---|---|
| Standard + Pamphlet | Placebo comparator | Subjects receiving standard counseling + ACOG pamphlets Receives: Behavioral: Pamphlet |
| Group 2: standard + facebook | Active comparator | Subjects receiving standard counseling + facebook education Intervention is 30 mins of use of facebook page Receives: Behavioral: Facebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive knowledge score
Subjects will be tested using the contraceptive knowledge inventory survey, which is a validated 25 question survey of contraceptive knowledge. Pre scores will be obtained. Intervention will then be completed and the survey will be administered again with post scores recorded. The improvement and overall scores will be numerically measured (both raw score out of 25 points and percentage correct)
Measured: 1 year
Secondary outcomes (1)
Contraceptive Choice
This is a outcome based on subject preference for contraception. Pre intervention contraceptive use will be recorded. Typically no contraception, barrier methods, hormonal, long acting reversible contraception and sterilization/abstinence are the choices. Subjects post intervention will also be asked their contraceptive choice/preference and analysis will be run to see if our intervention influenced the contraceptive choice by subjects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Jason Kofinas MD, New York Presbyterian Hospital
- Investigators
- Tirsit Asfaw, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994005
- Sponsor's protocol ID
- 5327714500
- Other IDs
- ACOG/Bayer Healthcare
- Status last verified
- Nov 2013
- First submitted
- 7 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kofinas JD, Varrey A, Sapra KJ, Kanj RV, Chervenak FA, Asfaw T. Adjunctive social media for more effective contraceptive counseling: a randomized controlled trial. Obstet Gynecol. 2014 Apr;123(4):763-70. doi: 10.1097/AOG.0000000000000172.
PubMed 24785602
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Adjunctive Social Media for More Effective Contraceptive Counseling
- ClinicalTrials.gov ID
- NCT01994005
- Acronym / sponsor ID
- 5327714500
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The scope of this project was to provide evidence that better contraceptive choices are made with more effective counseling as well as improvement in patients' contraceptive knowledge. Specifically we wanted to evaluate the use of social media as a means for effective patient counseling.
Detailed description
This study was performed at an urban obstetrics/gynecology clinic at New York-Presbyterian Hospital-Weill Cornell Medical Center. Institutional review board approval for this trial was obtained from the Weill Cornell Medical Center.
A total of 180 subjects, ages 18-45, were approached for enrollment into this study. Patients were eligible if they were scheduled for a new gynecologic visit, follow-up gynecologic visit, preconception counseling or post-partum visit. Patients who did not speak English or declined participation were ineligible as well as currently pregnant patients; 32 subjects were thus excluded. There were no exclusion criteria outside of age, language, currently pregnant status and willingness to participate. 148 patients met inclusion criteria and were randomized. 4 patients were excluded after randomization: 1 for not disclosing age, 3 for not completing the study (Figure 1). All patients provided written informed consent prior to randomization. Subjects in our population are a well-educated population. In a previous study conducted in the same clinic, 60% of women had some college education and another 29% had high school diploma or GED (unpublished data).
Randomization was achieved through an opaque envelope system. Equal numbers of opaque envelopes contained slips of paper with the number 1 or 2, signifying to the investigators the randomization group of each subject. Subjects were randomized to either standard counseling + pamphlet education (n= 74) or standard counseling + Facebook education (n=70). After randomization and prior to any intervention, a validated contraceptive knowledge survey (Contraceptive Knowledge Inventory, CKI)10 was administered to the subjects. The survey contained 25 questions specifically addressing general contraceptive knowledge and risks/benefits associated with different contraceptive methods. The subjects had unlimited time to complete the pre-intervention survey. Patients were also questioned about demographic information, including gravidity, marital status, age, and race/ethnicity, and their currently used contraceptive, including no contraceptive. A single provider then provided standardized counseling for all subjects involved in the study, which was conducted one-on-one. Standard counseling included discussion of barrier, hormonal, surgical and implantable/intrauterine devices. 15 minutes was allocated per patient for standard counseling in both groups. The goal of the standard counseling was to simulate a 15-minute in-office consultation specifically addressing contraception. Only American Congress of Obstetricians and Gynecologists (ACOG) derived facts were used, and a transcript was followed by the single provider, who was an M.D., to guarantee uniformity. The ACOG pamphlets were chosen for content pertaining to the CKI. Once the pamphlets were chosen, the Facebook page was constructed to be identical in content to the ACOG pamphlets.
Depending on the randomization group, patients were given 30 minutes to review ACOG patient education pamphlets specifically addressing contraception, or to interact with a Facebook page created by the investigators using identical content but in video, diagram and game format. The pamphlets were accessed on the ACOG website under patient education (www.acog.org). Following the intervention phase of the project, the subjects were administered the CKI again to assess post-intervention knowledge. At the completion of the post-intervention CKI, subjects were questioned regarding their preference for contraception and satisfaction with their counseling method. Subject satisfaction was measured in a similar fashion as clinical pain control. A 1-10 scale was used with 5 being neutral (i.e. the subject did not feel the method improves or negatively effects their counseling). A score of less than 5 was dissatisfaction with the counseling method and a score of greater than 5 signified satisfaction. 10 was a perfect score and meant the subject felt the intervention provided a significant improvement in counseling method.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard + Pamphlet | Placebo comparator | Behavioral: PamphletSubjects receiving standard counseling + ACOG pamphlets |
| Group 2: standard + facebook | Active comparator | Behavioral: FacebookSubjects receiving standard counseling + facebook education Intervention is 30 mins of use of facebook page |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-45 years of age
- English speaking
Key exclusion criteria (2 listed)
- <18 or >45 years old
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FacebookFacebook page with contraception information used for counseling | Behavioural | Group 2: standard + facebook |
| PamphletContraceptive knowledge pamphlets | Behavioural | Standard + Pamphlet |
Primary outcome
Contraceptive knowledge score
Time frame: 1 year
Subjects will be tested using the contraceptive knowledge inventory survey, which is a validated 25 question survey of contraceptive knowledge. Pre scores will be obtained. Intervention will then be completed and the survey will be administered again with post scores recorded. The improvement and overall scores will be numerically measured (both raw score out of 25 points and percentage correct)
1 secondary outcome
Contraceptive Choice
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Derived from this study: PubMed 24785602Kofinas JD, Varrey A, Sapra KJ, Kanj RV, Chervenak FA, Asfaw T. Adjunctive social media for more effective contraceptive counseling: a randomized controlled trial. Obstet Gynecol. 2014 Apr;123(4):763-70. doi: 10.1097/AOG.0000000000000172.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tirsit Asfaw, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facebook and Pamphlet in people with Contraception, run by New York Presbyterian Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive knowledge score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01994005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.