Adolescent Subcutaneous (SQ) Injection Video Validation

February 21, 2024 updated by: Tufts Medical Center

Validation of a Video Teaching Tool for Adolescent Self Administration of Subcutaneous Depot-medroxyprogesterone

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Clinic schedules for the medical providers on the research team will be reviewed in advance and any patient that is under the age of 20 and receiving depot-medroxyprogesterone will be contacted by telephone in advance to offer participation in the project.
  2. The telephone call will follow the attached script. Two attempts will be made to call patients.
  3. If subject is interested in participating, a prescription for the subcutaneous version of depot-medroxyprogesterone will be sent to their pharmacy to be picked up by the subject prior to the office visit.
  4. Subjects under 18 will be instructed that they must be accompanied by a parent or guardian. At the office visit, written consent/assent will be obtained. 5. Subject will be shown the instructional video, which is approximately 3 minutes long. Subject may view as many times as subject chooses.

6. Once ready, the healthcare provider from the research team will observe, without giving verbal instruction, the subject self administer a subcutaneous depot-medroxyprogesterone injection.

7. If at any point the provider feels that the subject is not performing the injection safely or correctly the healthcare provider will intervene to ensure that the medication is given correctly, and this will be recorded within the REDCap survey.

8. After the injection is given, the subject will fill out the REDCap survey, and the study team member administering injection will input observational data into REDCap.

9. Subject will be asked to repeat another questionnaire in REDCap at the time of the next injection which will be scheduled for 12 weeks later. The next visit is as per standard of care scheduling (this medication is routinely administered at approximately 12-week intervals). If the subject comes into the same office for the injection, the survey will be filled out in person. If the subject does not come into the same office, a link to the follow-up REDCap survey will be emailed to the subject with instructions on how to access the survey. Email addresses will be confirmed at the time of the first visit, as is routine for medical care.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02110
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • assigned females at birth aged 19 years and younger
  • must have previously received at least one injection of depot medroxyprogesterone

Exclusion Criteria:

  • never received a prior dose of depot medroxyprogesterone.
  • any history of self-administered injectable medication (either intramuscular or subcutaneous)
  • inability to understand written or spoken English
  • no parent or guardian to sign consent if under age 18
  • inability to watch the instructional video
  • cognitive impairment
  • pregnancy
  • ward of the state
  • prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teaching video
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Supervised self-injection
Time Frame: 12-18 months
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.
12-18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained self-injection
Time Frame: 12-18 months
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.
12-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00001518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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