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Research Looks at How Caregivers of Patients with Alzheimer’s Disease Make Tough Decisions

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www.ProHealth.com • April 6, 2001



New research looks at how family members and patients with Alzheimer’s disease make a tough decision: whether to enroll in a clinical trial to test a potential medicine for the disease. The study is published in the March 27 issue of Neurology, the scientific journal of the American Academy of Neurology.

Stress Affects Caregivers' Decision-Making

The research shows caregivers that experience stress and turmoil in caring for their loved ones may be less likely to enroll in a clinical trial than those whose experiences are less traumatic. In addition, caregivers are consistently involved in the final decision, while the patients' involvement ranges from not being aware of the trial's existence to participating in the final decision.

Study reported on caregivers decisions

The results are based on a study of the decision-making process of 22 family caregivers of patients with mild to moderate Alzheimer's disease who were asked to take part in a 15 month clinical trial to test a potential medicine for Alzheimer's disease.

"More and more of us are going to have to face difficult decisions as we care for loved ones with dementia," said Jason Karlawish, MD, lead author of the study from the Alzheimer's Disease Center at the University of Pennsylvania. “There have been numerous studies of potential treatments for Alzheimer’s disease. But no one has studied how patients and their families decide whether to be in these studies. We need to know this for two key reasons. The patients have dementia. This impairs their ability to provide an informed consent. Moreover, their family members are busy taking care of the patients. A clinical trial can add to their burdens or be used inappropriately as a way to relieve their burdens. In short, it is a morally problematic situation.”

Differences in Effects of Stress

The research also showed significant differences exist in the decision making of caregivers and patients who do and do not enroll. Those pairs that enrolled in the study saw the decision as their "only option" while those who decided not to enroll focused on the "hassles" and burdens, such as traveling to the study site.

"We saw that a patient whose caregiver experiences a lot of stress and related problems, such as depression and loss of control as a result of caregiving, may be less likely to enroll in a clinical trail than one whose caregiver experiences less stress," said Karlawish.

"Further research is needed to show whether such differences may in part explain the finding that patients with Alzheimer's disease who participate in clinical trials are less likely to be placed in a nursing home compared with patients who do not enroll."

Trust Is Essential

Finally, the researchers found that one of the key motivators to enroll in research was trust. The caregivers cited trust in the researchers, the clinic, the university and the pharmaceutical company that designed and sponsored the research. This trust helped to alleviate the uncertainties of the research and the desperation they feel at finding a treatment. Karlawish noted that “This finding all the more emphasizes the fragile foundation of the system of human subjects research and the importance of taking steps to preserve it.”

Alzheimer's Facts

Alzheimer's disease currently affects one in 10 people over age 65 and nearly half of those over age 85. More than 19 million Americans say they have a family member with the disease, and 37 million say they know somebody affected with Alzheimer's. The number of Americans with Alzheimer's disease is expected to grow from four million today to 14 million by 2050 if no cure or prevention is found.

The American Academy of Neurology, an association of more than 17,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research.



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