Cognition, Behavior and Caregiver Burden in Amyotrophic Lateral Sclerosis

Study Purpose:

The focus of this study is to investigate risk factors for development of problems with thinking, behavior and mood in Veterans with ALS and whether these problems affect their caregivers.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Primary Lateral Sclerosis (PLS), Other

Study Type:

Observational Study

Study Category:

Epidemiology

Study Status:

Active, currently recruiting

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Christopher Brady, PhD, VA Boston Healthcare Systems

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

No

Coordinating Center Contact Information

VA Boston Healthcare System
Nazifa Abdul Rauf / .(JavaScript must be enabled to view this email address) / 857-364-2136
.(JavaScript must be enabled to view this email address) 150 South Huntington Ave. (151C)
Boston, Massachusetts 02130 United States

Full Study Summary:

A new ALS research study, titled, "Cognition, Behavior, and Caregiver Burden in Amyotrophic Lateral Sclerosis" is being conducted by the Department of Veterans Affairs (VA). This study is designed to investigate whether there are risk factors for the development of problems with thinking, behavior and mood in Persons with Amyotrophic Lateral Sclerosis (PALS), and whether these problems affect their caregivers (e.g., spouse, adult child)

Questions We Want to Answer 

  1. How does ALS affect changes in your thinking, behavior and mood? Are there risk factors for the development of these changes?
  2. How do these changes affect your caregiver? Do caregivers have special needs that your healthcare provider should be aware of?

How ALS Can Affect Your Thinking and Behavior

This study is investigating whether amyotrophic lateral sclerosis (ALS) can cause problems in thinking, behavior, and mood. We are also interested in learning whether these problems affect caregivers. A caregiver is anyone who regularly cares for a person with ALS, and can be a spouse,  an adult child, or other family members.

We will ask you to complete tasks that will help us measure your thinking (such as attention, concentration, and memory), behavior, and mood. Additionally, we will ask your caregiver to complete surveys about you, his/her mood, and the challenges that he/she may face as a caregiver. These tasks and surveys will help us to understand whether there are different patterns of thinking and behavior problems that occur in people with ALS. We will also examine whether thinking and behavior problems are related to greater caregiver burden.

What can I expect if I take part in this study?

In order to take part in this study, you and your caregiver will both need to participate. After enrollment, you and your caregiver will complete some assessments by telephone and by mail. This may take up to an hour of your time for each of you. About 6 months after the initial assessment, we will ask your caregiver to answer some questions over the phone and complete some brief questionnaires. Your caregiver will answer questions regarding their observations of your thinking, behavior, and mood, as well as whether they are experiencing any challenges or burdens as a result of caregiving.

A year after enrollment, you and your caregiver will have another telephone interview and be mailed questionnaires similar to the initial assessment. These annual and 6-month follow-ups (caregivers only) will continue for up to 3 years.

Study Sponsor:

VA BLR&D

Participant Duration:

Any Veteran with ALS (VALS) and their caregiver may be eligible to participate in the study. As this is a VALS/caregiver study, both VALS and their primary caregiver need to participate in order to take part in the study. Participants will be asked to complete surveys by mail and telephone semi-annually for up to three years. This may take up to one hour of their time for each follow up. This study does not require any travel, as all assessments are done by phone and mail.

Estimated Enrollment:

100

Estimated Study Start Date:

Estimated Study Completion Date:

Posting Last Modified Date:

10/16/2017

Date Study Added to alsconsortium.org:

10/16/2017