An interventional study of watch an instructional video in Medication Compliance, Contraception and Self-Evaluation, sponsored by Tufts Medical Center. Active, not recruiting at 1 site in United States. Open to female participants aged Up to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Tufts Medical Center · Not applicable, Interventional, and Other
This is a study to determine if a video that utilizes a peer to teach self administration of subcutaneous depot medroxyprogesterone is both effective and well accepted by adolescent patients who are already receiving ongoing treatment with depot medroxyprogesterone by a medical provider via an inter muscular injection. Self administration can be done at home and therefore offers an alternative to traveling to a medical office.
Means of providing health education are rapidly evolving. Telemedicine has become an important modality to provide healthcare and improve access, and will likely be increasingly utilized beyond the COVID-19 pandemic. Telemedicine can effectively provide care and counseling to all age groups, including adolescents. Studies have demonstrated that over 80 percent of adolescents between the ages of 11 and 18 spend one to four hours a day online; searches for health-related information are common. Nevertheless, adolescents may face obstacles when previously familiar aspects of their medical care are abruptly moved online, particularly when discussing contraception. Although traditionally administered in the clinical space, injectable contraception has been shown to be attractive, effective, and well-tolerated by adolescents when subcutaneously self-administered, and can lead to improved continuation rates. The investigators have found that remotely teaching a patient how to self-administer a subcutaneous injection is challenging. The provider may be in a home office, and may not have access to the actual medication or the supplies to demonstrate technique. The patient may struggle to understand verbal instruction without a visual demonstration, resulting in ineffective medication administration. Instructional videos currently available online are not specific to adolescents who use self-administered injectable contraception. Peer education can be relatable and effective for adolescent patients. The investigators propose that self-administration of subcutaneous injectable contraception may be taught using a peer-to-peer video as a synchronous or asynchronous adjunct to consultation with the healthcare professional. Adolescents may be instructed to watch the video demonstration to help inform them about proper technique and ensure safe administration of their medication while at home. This study aims to validate an existing video as an effective teaching tool by assessing metrics such as clarity of the instructions, rate of error, and satisfaction with the video teaching method to the investigators' target population. The video was filmed in accordance with Tufts Medical Center Department of Marketing and Communications policies and the adolescent participant in the video was appropriately consented by a parent/guardian. The video was presented as an oral abstract at the North American Society for Pediatric and Adolescent Gynecology Annual Meeting in March 2021.
Procedure:
Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is a single arm interventional study wherein the subjects enrolled will all participate in the study in the same way by watching the teaching video and then will be asked to self inject subcutaneous depot-medroxyprogesterone as per the protocol. All participants will then be asked to answer survey questions. All health care providers that participate in the study will likewise be asked to answer survey questions.
Behavioral: watch an instructional video
watch instructional video and then perform self injection of subcutaneous depot-medroxyprogesterone based on the video teaching
Supervised self-injection
This measure is coded 1 if the patient successfully completes self-injection at the first session after watching the video. Otherwise, the measure is coded 0. Incomplete attempts, such preparing for but not completing the injection, will be coded 0.
Time frame: 12-18 months
Sustained self-injection
This measure will be a count of self reported self injections in the 10-14 weeks following initial visit. This information will be collected through a self reported electronic REDCap survey that is administered once after the initial survey.
Time frame: 12-18 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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