Risks
As in all studies, there are some risks associated with participating and providing your information. One of such risks is loss of confidentiality as a result of study participation (e.g., in case of a data security incident). There may be other unknown risks that you may need to consider as well.
Benefits
You are not expected to directly benefit from participating in this study. However, if you are randomized to be in the intervention group, you may experience some positive impact on your health literacy, self-reported symptoms, quality of life and productivity. Participants in the control group may experience the same at the end of the study when they will be provided with the Flo app. You will also be helping us further our understanding of PMS and its
impact on women’s health regardless of group allocation.
Alternative to study participation
This is not a treatment study. Your alternative is not to participate in this study.
Questions
If you have questions, concerns, or complaints, or think this research has hurt you or made you sick, talk to the research team at the phone number listed above on the first page.
This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at 855-818-2289 or researchquestions@wcgirb.com if:
-You have questions, concerns, or complaints that are not being answered by the research team.
-You are not getting answers from the research team.
-You cannot reach the research team.
-You want to talk to someone else about the research.
-You have questions about your rights as a research subject.
Voluntary participation
Your decision to participate or to stop your participation at anytime during the study will have no penalty or loss of benefit to which you are otherwise entitled.
Withdrawal from the study
You may withdraw at any time by letting the study staff know your decision. You may also be removed from the study without a reason by the study staff. If at any time you wish to remove yourself from the study and would like to request your personal data to be removed, please contact us at research@flo.health.
Payment for participation
Both control and interventional groups will get Flo Premium for 1 year. Control group will get Flo Premium only after the 3 months upon the study completion. Participants who completed the 3-month study will be invited to take part in a raffle with a chance to win up to $550 (550$ (1x); 500$ (2x); 250$ (5x); 100$ (10x); 50$ (13x)).
Compensation for Injury
If you feel that you may be injured as a result of study participation, contact the study staff on the first page of the consent form. Your study staff will refer you to treatment. You or your insurance company will be responsible for the costs of such treatment.
By choosing to complete the survey, you agree to Flo Health processing your sensitive personal data for the purposes of analysis as described above.