Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use of an Online Learning and Consent Platform in Infertility Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03962257
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE March 30, 2019
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
Patient understanding [ Time Frame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks. ]
Patient understanding of infertility diagnoses and treatment by use of a pre and post test. The test comprises of 15 multiple choice questions and the patients will receive a score of 0-15 and this will be compared as a paired continuous variable from the pre-test score to their post-test score as well as an un-paired continuous variable between the conventional group and the EngagedMD group for pre- and post-test scores as well as delta scores between the two.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
Patient satisfaction [ Time Frame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks. ]
Patient satisfaction with their infertility treatment and consent processes will be assessed using questionnaires using a 5 point Likert scale progressing from very unsatisfied to very satisfied across a number of questions. The 5 point Likert questions will be assigned a value of 1-5 (with 1 being very unsatisfied and 5 being very satisfied) and will be assessed as a sum of points from the individual questions and compared as continuous variables between the conventional arm and the EngagedMD arm. There is an additional question asking patients to rank their satisfaction on a scale of 1-10 (with 1 being not satisfied at all and 10 being extremely satisfied) which will be used independently as a measure of patient satisfaction overall.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
Patient satisfaction [ Time Frame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks. ]
Patient satisfaction with their infertility treatment and consent processes will be assessed using questionnaires using a 5 point Likert scale progressing from very unsatisfied to very satisfied across a number of questions. The 5 point Likert questions will be assigned a value of 1-5 and will be assessed as a sum of points from the individual questions and compared as continuous variables between the conventional arm and the EngagedMD arm. There is an additional question asking patients to rank their satisfaction on a scale of 1-10 which will be used independently as a measure of patient satisfaction overall.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of an Online Learning and Consent Platform in Infertility Treatment
Official Title  ICMJE Improving the Informed Consent Process for Infertile Patients Undergoing Assisted Reproductive Technology (ART) With EngagedMD
Brief Summary The primary purpose of this study is to objectively assess if interactive multimedia tutorials (online videos) enhances patients' comprehensive understanding of assisted reproductive technology (ART) adding EngagedMD, an online library of interactive videos, compared to the traditional process of consent and one-on-one teaching using a 15 question evaluation. The secondary outcome will be to qualitatively assess patients' overall experience of the teaching process comparing the addition of the EngagedMD content to solely traditional teaching for infertility treatment.
Detailed Description

Participants: This will be a multi-center trial with each center planning on recruiting 100 couples. Half of the couples will be planning on undergoing ovulation induction with insemination (OI/IUI) and the other half in-vitro fertilization (IVF).

Procedures (methods): This is a multi-center prospective randomized controlled trial where couples undergoing OI/IUI or IVF will be randomized to receiving the current traditional standard of in-person treatment teaching by their physician and nursing team with standard paper consents or to the identical process of in-person teaching with the addition of unrestricted access to the EngagedMD online video resource platform with online consents.

Patient demographics, knowledge base, psychological impact of with the treatment, teaching and the consent process and overall satisfaction with the process as a whole will be assessed using surveys administered at three time points throughout the treatment process. A subset of patients that agree will be contacted after the completion of the treatment cycle for a live phone interview.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial comparing one group receiving standard care and the other with standard care with the addition of the online learning platform
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Patient Satisfaction
Intervention  ICMJE Other: EngagedMD online learning platform
The EngagedMD online learning platform is a compilation of learning modules and questions designed to give patients at-home access to visual and audio aids in infertility treatment. It also gives patients the ability to read and sign consents from home.
Study Arms  ICMJE
  • No Intervention: Conventional
    This group will have standard of care infertility counseling and consent processes.
  • Experimental: Engaged MD
    This group will have standard of care infertility counseling and access to online teaching modules and the ability to sign consents online.
    Intervention: Other: EngagedMD online learning platform
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female subjects must be 18-49 years of age undergoing fertility treatment
  • Able to give Informed Consent

Exclusion Criteria:

  • Patients who do not have adequate command of the English language to provide informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Linnea R Goodman, MD 919-908-0000 linnea_goodman@med.unc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03962257
Other Study ID Numbers  ICMJE 18-3258
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linnea R Goodman, MD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP