NCT01990001

Brief Summary

The broad objective of this research is to determine whether a quick, simple intervention will increase utilization of contraceptive reminders and adherence to short-term contraceptive regimens. Such an intervention could be implemented easily with no additional resources into a busy clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 23, 2015

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

November 11, 2013

Last Update Submit

September 22, 2015

Conditions

Keywords

contraception, adherence, medication reminder

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients using the online reminder tool three months after enrollment

    Measure the difference in reminder utilization over three months between patients who are assisted with initiating the reminder system during their office visit versus those who are encouraged to self-initiate after the visit. The primary outcome, which is proportion of reminder users, will be assessed three months after enrollment

    3 months

Secondary Outcomes (1)

  • Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit.

    3 months

Study Arms (2)

Office enrollment in the online contraceptive reminder system

EXPERIMENTAL

Members of this arm were enrolled in the reminder system during their visit.

Other: enrollment in online reminder system

Control

NO INTERVENTION

Members in the control group were not enrolled in the reminder system

Interventions

Study personnel enrolled members in the online reminder system during their office visit.

Office enrollment in the online contraceptive reminder system

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female, 18-29 years old
  • Prescribed one of the following birth control:
  • Oral contraceptive pills, vaginal ring, transdermal patch, or Depo Provera
  • Able to provide consent
  • Have regular access to a computer, Ipad, or a hand-held device such as a smartphone.
  • Women must be able to read and speak English(Bedsider website in not translated into Spanish)

You may not qualify if:

  • Male
  • Over the age of 30 years old
  • Non-English Speaking
  • Limited or no access to computer, Ipad or hand-held device(smartphone)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUSC Women's Health- Cannon

Charleston, South Carolina, 29425, United States

Location

Study Officials

  • Ashlyn Savage, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 21, 2013

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 23, 2015

Record last verified: 2013-11

Locations