Title: Essential Coaching for Every Mother: Evaluating an mHealth postnatal intervention for mothers of newborns (Phase II – Randomized Control Trial)
Ms. Justine Dol, PhD Candidate, Faculty of Health, Dalhousie University, Justine.email@example.com
Dr. Marsha Campbell-Yeo, Professor, School of Nursing, Dalhousie University, firstname.lastname@example.org
Dr. Gail Tomblin Murphy, VP Research & Innovation, Nova Scotia Health Authority
Dr. Megan Aston, Professor, School of Nursing, Dalhousie University
Dr. Douglas McMillan, Neonatologist, IWK Health Centre
Funding: IWK Health Centre Mentored Grant; IWK Health Centre Ross Fund
We invite you to take part in a research study lead by Ms. Justine Dol and Dr. Marsha Campbell-Yeo and co-investigators Dr. Gail Tomblin Murphy, Dr. Megan Aston, and Dr. Douglas McMillan. This letter explains the study and the process of informed consent. Choosing whether or not to take part in this research is entirely your choice. There will be no impact on you if you decide not to participate in the research. The information below tells you about what is involved in the research, what you will be asked to do and about any benefit, risk, inconvenience or discomfort that you might experience. If you decide to participate in this research, you can change your mind at any time and withdraw from the study with no impact. If you have questions, please contact the lead researcher.
Why are the researchers doing the study?
The purpose of this study is to determine the effectiveness of Essential Coaching for Every Mother on mothers’ postpartum adjustment. Essential Coaching for Every Mother is a text message intervention that provides mothers information about caring for themselves and their babies from the period of birth to six-week after birth. All text messages have been developed and piloted with mothers and postpartum healthcare providers in Halifax. Messages are consistent with World Health Organization guidelines as well as the Loving Care books created by Nova Scotia’s Department of Health and Wellness.
Who Can Take Part in the Research Study?
You can take part in this study if you are a women who lives in Nova Scotia and delivered a baby within the past 10 days; has daily access to a mobile phone with text message capabilities; are over 18 years of age; and speak and read English.
What Will I Be Asked to Do?
If you want to participate, you will be randomized (like flipping a coin) into one of two potential groups. One group will receive messages from Essential Coaching for Every Mother and the other will be a control group. The intervention group will receive a daily text message in the morning (10am) and evening (5pm) for the first two weeks, followed by a daily text message at 10am for the following 4 weeks. All messages will be sent within six-weeks after your baby was born. The control group will not receive any study messages during the six-week period. Your group allocation will not have impact on your care provided in the hospital or in the community during the postpartum period.
Both groups will be asked to complete a baseline survey upon enrollment and a follow-up survey at 6 weeks and 6 months postpartum. The surveys will be sent to you in a link by text message. The survey should take approximately 20 minutes for baseline and six-month follow-up and 30 minutes for the six week follow-up. You may choose not to answer any questions or stop the survey at any time.
The survey at all times is similar. You will be asked questions about yourself and your baby, your confidence in caring for your baby, your social support, as well as be asked questions regarding potential anxiety and depression. If you are part of the intervention group, you will also be asked to provide feedback on the messages during the six-week follow-up survey.
What are the burdens, harms, or potential harms?
The potential harms for you participating in this research is minimal. If you become upset during the survey, you can take a break, decide not to answer specific questions, or stop the survey completely. If you are part of the intervention group, you have the ability to opt of the messages at any time by texting ‘STOP’.
Please be aware that these text messages will not replace the need to visit a healthcare provider if you have a concern about yourself or your newborn. The system will not be able to respond to any emergency (i.e., the messages are only outgoing and will not be responded to) and you should seek professional help in person if you need it. Please contact your public health nurse, family doctor, or Emergency Rooms as appropriate.
What are the potential benefits?
Participating in the study might benefit you personally by increasing your knowledge about newborn care. It will also help us learn things that will benefit others and improve postnatal care in Halifax.
What will I receive for taking part?
To thank you for your time, you will be provided with a $15 gift card upon completion of each of the surveys. It is not anticipated that you will incur any costs for participation as the surveys will be completed online.
How will my information will be protected?
Only Ms. Justine Dol and Dr. Marsha Campbell-Yeo will have access to any identifying information. Any names or identifying information will be removed on survey data and your name will not be used in any reports or publications. Survey data will be kept on a secure server at the IWK Health Centre for 5 years after study publication, after which they will be deleted. Data will be shared with the research team through secure electronic files that are password protected, if necessary.
Your name, phone number, child’s name, preferred pronoun, and child’s date of birth will be disclosed as part of this study to TextIt and stored with Amazon Web Services in the United States for the purpose of transmitting the SMS messages in this study. After the study has ended your contact information will be deleted. See the European Union General Data Protection Regulation for more information on TextIt’s and AWS’ privacy practices. Your phone number and email address will be maintained in the RedCap database but will not be linked to your survey responses. Only Justine Dol and Dr. Campbell-Yeo will have access to this information.
Please note that, in the rare event that we should learn anything during the course of your participation in our study that would cause us to believe that you or your child is in danger, Dr. Campbell-Yeo would follow-up with you directly via email or phone call. Further, in accordance with provincial laws, in the rare event that we learn anything during the course of your participation in our study that would cause us to believe that your child was being harmed, we would be required to report this to a child protection agency. If any issues do arise as a result of your participation in our study, you are encouraged to contact Dr. Campbell-Yeo at (902) 470-2645.
Can I withdraw from the study?
You are free to leave the study at any time. If you decide to stop participating at any point in the study, you can also decide whether you want any of the information you shared with us up to that point to be removed. Basic demographic information will be maintained to determine if any differences exist between participants who withdrew and those who continued involvement.
Are there any conflicts of interest or possible profit from commercialization of the study results?
There are no conflicts of interest to disclosure nor possible profit from commercialization of the study results.
How will I be informed of the study results?
A summary of the results will be provided and available on the mom-linc.ca and justinedol.com website which should be available 12 months after study completion. You also have the option to have the results sent to you by email.
What if I have any questions about the study?
We are happy to talk with you about any questions or concerns you may have about your participation in this research study. Please contact Ms. Justine Dol (Justine.Dol@dal.ca, 902-580-3943) or Dr. Campbell-Yeo (email@example.com, 902-470-2645) at any time with questions, comments, or concerns about the research study. We will also tell you if any new information comes up that could affect your decision to participate. If you have any ethical concerns about your participation in this research, you may also contact Research Ethics, IWK Health Centre at 902-470-7978, Monday to Friday, 8am-4pm.