Interventions for Patients With Alzheimer's Disease and Dysphagia

This career development proposal is designed to provide Nicole Rogus-Pulia, PhD, CCC-SLP, a
Speech-Language Pathologist and an expert in dysphagia (swallowing dysfunction) at the
University of Wisconsin-Madison School of Medicine and Public Health with the training
required for success as an independent, clinician scientist researching interventions to
improve the care of dysphagia in patients with Alzheimer's Disease (AD). Dysphagia frequently
develops in patients with AD and leads to decreased quality of life as well as serious health
consequences, including malnutrition, pneumonia, and death. Common treatments for dysphagia
in patients with AD employ compensatory approaches that alter bolus flow to avoid aspiration
(entrance of food or liquid into the airway). These approaches do not result in sustained
improvements in swallowing physiology and often negatively affect quality of life. There are
currently no effective treatments for dysphagia in patients with AD that can be practically
applied or have lasting effects on the physiology of the swallow. The goal of Dr.
Rogus-Pulia's proposed research is to develop effective dysphagia rehabilitative
interventions for patients with AD at risk for pneumonia development. Progressive-resistance
lingual strengthening and saliva substitute are two interventions that have been shown in
preliminary studies to positively influence swallowing function in older adults. This
proposal will consist of a small, pilot randomized clinical trial to 1) determine the impact
of two novel interventions on proximal swallowing outcomes in patients with AD and 2)
identify subgroups of patients most likely to benefit from these interventions.
Patient-caregiver dyads will be randomized to lingual strengthening, saliva substitute use, a
combination of the two, or usual care. Saliva and swallowing-related outcomes will be
collected at baseline and following the 8 week intervention period. These data will support a
larger, multi-site R01 funded study to determine effectiveness of these interventions for
prevention of pneumonia development in patients with AD. As a junior faculty member at an
institution with extensive infrastructure to support early stage investigators, Dr.
Rogus-Pulia is in an ideal environment to complete the proposed research and pursue advanced
training. Her career development plan includes both coursework and mentored training in the
areas of 1) clinical trials design and analysis, 2) Alzheimer's disease research, 3) advanced
statistical techniques, 4) implementation science, and 5) human factors and healthcare
systems engineering. To ensure success, she has identified committed, expert mentors in these
disciplines and secured protected time for this work. This award addresses a significant
clinical dilemma and serious gap in AD research while affording the education and mentored
research experience critical for Dr. Rogus-Pulia to lead an independent dysphagia research
program.

Inclusion Criteria for Patients

1. Non-hospice inpatient or outpatient seen at University of Wisconsin Hospital and
Clinics

2. Age 18-99

3. English-speaking

4. A documented pre-hospitalization diagnosis of mild-moderate dementia

5. Must have videofluoroscopic swallow study ordered by their clinician as part of their
clinical care

6. Diagnosis of oropharyngeal dysphagia based on the videofluoroscopic swallow study
(Penetration-Aspiration scale score of 3 or higher and/or moderate oropharyngeal
residue in any location in the oral cavity or pharynx)

7. Actively involved caregiver

8. Resides at home

Inclusion Criteria for Caregivers

1. English speaking

2. Age 18-99

3. Contact with patient at least 3 times a week

4. Has access to a working telephone

Exclusion Criteria for Patients

1. Discharged to institutional settings (e.g., other hospitals, skilled nursing
facilities, long-term care centers)

2. Discharged to hospice

3. Current/active stroke diagnosis

4. History of head and neck cancer or other structural deformity that can affect
swallowing

5. Allergy to barium

6. Currently pregnant or planning to become pregnant

Exclusion Criteria for Caregivers

1. Lacks ability to give consent