American College of Rheumatology and Pack Health LEADR Lupus Randomized Control Trial
This study is to explore the feasibility and impact of a 3-month multi-channel digital health coaching program in Black and African American women living with lupus.
This study is to explore the feasibility and impact of a 3 month multi-channel digital health coaching (DHC) program in Black and African American women living with lupus. Participants will be randomly assigned to either receive standard care and a digital education packet or be assigned a health coach. All participants involved in the study will receive a FREE FitBit Inspire and will be asked to use it to track daily activity. Patient reported outcomes will be collected periodically throughout the study via surveys and qualitative interviews to assess study results. Participants who do not receive coaching will receive an additional $20 Amazon gift card (total of two gift cards) for data collection at the beginning and end of the study. If you are interested in participating in the study, please read the FAQ’s on this page and enter your information below. Somebody from the Pack Health study team will reach out to you to discuss eligibility and enrollment details.
NOTE: ENTERING YOUR INFORMATION DOES NOT ENROLL YOU IN THE STUDY. PLEASE DISREGARD THE LANGUAGE DISPLAYED AFTER SIGNING UP.
What is a randomized control trial or RCT?
A randomized control trial is a type of study where people are picked at random to receive one of a group of interventions. The persons participating do not know which group they will be assigned to, prior to receiving that assignment. One of the interventions is the standard of comparison, also known as the control group. It is that to which the new or different intervention(s) are being compared. The other arm or arms are the groups receiving the new or different intervention/therapy being tested out. As the study progresses, the only expected difference between the control group and the group(s) receiving the intervention(s) is the outcome of interest.
Who is involved in the study?
This study is being conducted by Pack Health, with the support of the American College of Rheumatology (ACR). Pack Health is a patient engagement platform that uses evidence-based behavioral strategies to change health behaviors to close gaps in care and improve outcomes. American College of Rheumatology is a professional membership organization that is committed to improving the care of patients with rheumatic disease and advancing the rheumatology subspecialty.
Who is paying for this study?
The production of this activity was supported by Grant Number MP-CPI-15-001 from the U.S. Department of Health and Human Services Office of Minority Health (HHS, OMH). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS, OMH. 1 CPIMP201213-01-00, CFDA number 93.137 No commercial support was obtained.
What are the groups that make up the study?
One of the interventions is the standard of comparison, also known as the control group. It is that to which the new or different intervention(s) are being compared. The other arm or arms are the groups that are receiving the new or different thing being tested out.
The control group in this study will be receiving a packet of information via email or postage mail on physical activity and lupus. They will receive a FitBit Inspire and will be asked to link the FitBit to track their physical activity They will be asked to complete a survey at the beginning and end of the three-month study period. They will receive a $20 Amazon gift card for completing each of the surveys ($40 total by the end of the study).
The intervention group in this study will be receiving the digital health coaching intervention. This means that they will be assigned a health coach that will walk them through the Pack Health program for the three-month study period. They will also receive a FitBit Inspire and will be asked to link the FitBit to track their physical activity. They will also be asked to complete a survey at the beginning and end of the three-month study period.
What do I have to do to participate in the study?
To participate in the study, you will first need to enter your contact information in the Pack Health portal. Doing this does NOT enroll you directly in the study. It simply allows Pack Health to have your contact information so they can contact you to answer any further questions about the study and review the study eligibility, requirements, and consent.
If you are eligible for the study, and would like to move forward with participating, the recruitment coordinator will go over the informed consent with you over the phone. If you consent to the study, you will be placed in the study and will be randomized to a group. You will find out which group you have been assigned to during the week of June 21st via email.
Once you receive the introductory email, you will be asked to immediately complete the baseline survey. You will also be asked to set up your FitBit Inspire and connect it to the Pack Health platform as soon as you receive it. You will then participate in whichever study activities you have been assigned for three months. At the end of the three month period you will receive a final survey that you are also required to complete. Once you complete the final survey, you will be officially notified that you have finished the study.