STUDY FACT SHEET FORM
Please keep a copy of this form in case you have any questions.
Study Title: A Study to Assess Mental Health Support for Patients with ALS and their Caregivers
Principal Investigator: Dr. Ethan Lester, PhD
Contact Information: elester@mgh.harvard.edu; 617-643-2704
Who are we?
We are clinical researchers from the Sean M. Healey and AMG Center for ALS and the Center for Health Outcomes and Interdisciplinary Research (CHOIR) at Massachusetts General Hospital in Boston, MA.
What is the purpose of this study?
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the spinal cord and brain leading to loss of motor control and eventually problems breathing, swallowing, and paralyses. There is no cure for ALS. Treatments primarily focus on slowing down progression of disease with drug therapies and multidisciplinary care (e.g., physical, occupational, and speech therapy). In addition to the physical toll of ALS, the social and emotional consequences are considerable. People with ALS and their caregivers often struggle to find support to help cope with the emotional distress (anxiety, depression, stress, psychosocial adjustment) that can come with ALS. We are interested in understanding what your experience is of available resources for people with ALS and caregivers and how this is offered by your provider. The information gathered from survey will help inform the ALS community and used to further develop psychosocial interventions for people with ALS and their caregivers.
How did you get my name and how many people will take part in this study?
You have signed up for one of our email lists to get updates related to research being conducted at the Healey Center at MGH or are otherwise connected with an ALS provider or organization that shared the link for this study. We plan to recruit at least 200 people living with ALS and caregivers, and at least 50 providers to take part in this study.
How long will it take?
If you decide to complete this survey, it will likely take you 20-30 minutes to complete the entire questionnaire.
What will happen if I take part in this study?
You will be asked to complete survey one time. This can be done via REDCap remotely, or in person with study staff at MGH.
What other information will you be collecting about me?
We will only be collecting the information you provide in the survey. We will collect your email address and initials to help ensure that you do not have multiple entries. If you are a participant with ALS and a patient at MGH, we may go into your medical record to collect additional information about your disease history.
How may I benefit from this study?
Although you will not directly benefit from partaking in this survey, your participation will help in the research to enhance mental health resources for patients with ALS and their caregivers.
Do I have to participate in this study?
No, participation in this study is completely voluntary. Deciding not to participate won't affect medical care you receive at Mass General Brigham now or in the future, or any benefits you receive now or have a right to receive.
What are the possible risks or discomforts involved from being in this study?
You may find it a physical and emotional burden to complete the questionnaires related to the study. You may get tired or bored when completing the questionnaires. Data will be stored on servers meeting HIPAA requirements, but it is possible for the server to be hacked and for information to be stolen.
Will I be paid to participate in this study?
No. There will be no compensation for participation in this study.
How will my data be kept confidential?
All HIPAA regulations regarding confidentiality of participant information will be satisfied throughout the study. Information will be stored in REDCap. If you choose to complete the visit in person, the information will be entered by study staff into REDCap and the original documents will be stored in a secure location that only study staff will have access to. Any downloaded data from REDCap will be deidentified and stored on secure servers at MGH. Your de-identified information may be used or shared with other researchers without your additional consent.
We are required by the Health Insurance Portability and Accountability Act (HIPAA) to protect the privacy of health information obtained for research. This is an abbreviated notice, and does not describe all details of this requirement. During this study, identifiable information about you or your health will be collected and shared with the researchers conducting the research. In general, under federal law, identifiable health information is private. However, there are exceptions to this rule. In some cases, others may see your identifiable health information for purposes of research oversight, quality control, public health and safety, or law enforcement. We share your health information only when we must, and we ask anyone who receives it from us to protect your privacy.
What if I have questions about my rights as a research participant?
If you wish to speak with someone not directly involved in this research about your rights as a research subject, or any concerns or complaints you may have about the research, contact the Partners Human Research Committee at 857-282-1900.