PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Dementia is a health problem that can cause memory loss, behavior and mood changes, inability to perform daily tasks, falls, and swallowing problems. Alzheimer’s disease is the most common form of dementia, affecting about 5.7 million people in the United States. Symptoms of dementia can lead caregivers to have stress, depression, and illness.

This study compares three ways to reduce behavior problems in patients with dementia and to lower stress among family members or friends who care for them. In the first way, a nurse practitioner or physician assistant manages dementia care with the patient’s primary care doctor. In the second way, a nurse or social worker based at a community center manages care over the telephone. The third way is usual care plus referral to the Alzheimer’s Association hotline.

Who can this research help?

Results can help doctors, patients, and caregivers when considering ways to manage dementia.

What is the research team doing?

The research team is recruiting 2,150 patient-caregiver pairs from primary care clinics. All patients in the study have dementia. All live at home or in an assisted living facility. The team is assigning each patient-caregiver pair to one of three groups by chance. Patients in all three groups take part in their assigned program for 18 months.

In the first group, 1,000 patients are receiving dementia care from a nurse practitioner or physician assistant within a primary care clinic. A doctor oversees and adjusts care based on patient and caregiver needs.

In the second group, 1,000 patients are receiving dementia care from a nurse or social worker based at a community center. The program gives equal attention to patients and caregivers. Caregivers can take part in the program even if patients can’t because of their dementia. Program content, resources, and referrals are tailored to patient and caregiver needs.

In the third group, 150 patients receive standard dementia care plus educational materials and referral to the Alzheimer’s Association hotline. This hotline provides decision-making support, crisis help, caregiver education, and referral to local services.

Caregivers complete a survey at the time they enter the study. They complete the survey again 3, 6, 12, and 18 months later. Across the three groups, the research team is comparing caregivers’

• Perceptions of the patient’s behavioral symptoms
• Level of strain
• Distress related to the patient’s dementia
• Severity of depression
• Confidence in their ability to manage the patient’s dementia

Patients with early stage dementia, caregivers, health system leaders, insurers, and advocacy groups are helping plan and conduct the study.

Research methods at a glance