ContraceptionNCT05317468
Assessing Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits
A study testing Contraceptive Counseling in people with Contraception and Health Care Utilization, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The Contraceptive Choice Center (C3) will compare the patient experience between patients receiving contraceptive counseling using a telephone versus video telehealth model. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Contraception, Health Care Utilization
- What is being tested?
- Contraceptive Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 26 Jun 2023
- 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 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to speak and read English
- Access to video-capable technology
Who cannot join
- Incarceration
- Unable to provide informed consent secondary to language barrier or cognitive limitation
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Pilot Randomized Controlled Trial to Assess Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits
The Contraceptive Choice Center (C3) will compare the patient experience between patients receiving contraceptive counseling using a telephone versus video telehealth model.
Read the detailed description
The Contraceptive Choice Center (C3) will offer contraceptive counseling to patients via telehealth. Participants will be randomized to receive counseling via video or telephone. We will compare patient satisfaction with contraceptive counseling, receipt of desired contraceptive method, and identification of barriers with technology use.
- Conditions
- Contraception, Health Care Utilization
- Being tested
- Contraceptive Counseling
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive CounselingOther
Patients will receive contraceptive counseling to review all available contraceptive methods prior to their visit with a clinician.
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | Patients will complete contraceptive counseling using a video-based platform. Patients and counselors will have an audio and video connection. Receives: Other: Contraceptive Counseling |
| Telephone | Experimental | Patients will complete contraceptive counseling on a telephone call. Patients and counselors will have an audio connection only. Receives: Other: Contraceptive Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Assessed by IQFP
Interpersonal Quality in Family Planning (IQFP) scale
Continuous score: 11-55, higher scores indicate higher patient satisfaction Dichotomous: highest score (55) versus lower scores, highest score indicates highest patient satisfaction
Measured: Baseline
Secondary outcomes (2)
% of Patients Receiving Desired Contraceptive Method Assessed by Medical Record Review
Measured: 30 Days Post Baseline
% of Patients Reporting Barriers to Technology Use Assessed by Baseline Questionnaire
Percentage of patients reporting limited access to mobile telephone or computer with video capabilities, unreliable telephone or internet service, and environmental distractors (i.e. loud noises, lack of privacy)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Jun 2022
- Primary completion14 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Jennifer A Reeves, MD, MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317468
- Sponsor's protocol ID
- 202203067
- Status last verified
- Oct 2024
- First submitted
- 23 Mar 2022
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial to Assess Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits
- ClinicalTrials.gov ID
- NCT05317468
- Acronym / sponsor ID
- 202203067
- Conditions
- Contraception, Health Care Utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 7 Apr 2022 (actual)
- 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 Contraceptive Choice Center (C3) will compare the patient experience between patients receiving contraceptive counseling using a telephone versus video telehealth model.
Detailed description
The Contraceptive Choice Center (C3) will offer contraceptive counseling to patients via telehealth. Participants will be randomized to receive counseling via video or telephone. We will compare patient satisfaction with contraceptive counseling, receipt of desired contraceptive method, and identification of barriers with technology use.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Other: Contraceptive CounselingPatients will complete contraceptive counseling using a video-based platform. Patients and counselors will have an audio and video connection. |
| Telephone | Experimental | Other: Contraceptive CounselingPatients will complete contraceptive counseling on a telephone call. Patients and counselors will have an audio connection only. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Able to speak and read English
- Access to video-capable technology
Key exclusion criteria (2 listed)
- Incarceration
- Unable to provide informed consent secondary to language barrier or cognitive limitation
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 |
|---|---|---|
| Contraceptive CounselingPatients will receive contraceptive counseling to review all available contraceptive methods prior to their visit with a clinician. | Other | Telephone, Video |
Primary outcome
Patient Satisfaction Assessed by IQFP
Time frame: Baseline
Interpersonal Quality in Family Planning (IQFP) scale Continuous score: 11-55, higher scores indicate higher patient satisfaction Dichotomous: highest score (55) versus lower scores, highest score indicates highest patient satisfaction
2 secondary outcomes
% of Patients Receiving Desired Contraceptive Method Assessed by Medical Record Review
Time frame: 30 Days Post Baseline
% of Patients Reporting Barriers to Technology Use Assessed by Baseline Questionnaire
Time frame: Baseline
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 1 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
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.
Jennifer A Reeves, MD, MPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contraceptive Counseling in people with Contraception and Health Care Utilization, run by Washington University School of Medicine 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 1 Nov 2024. 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. 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?
Patient Satisfaction Assessed by IQFP (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2024.