Clinical trial NCT03682081: Interventions for Patients With Alzheimer's Disease and Dysphagia
Official title: Impact of Novel Rehabilitative Approaches for Dysphagia in Patients With Alzheimer's Disease and Related Dementias
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Dysphagia
Alzheimer Disease
Keywords: Dementia
Dysphagia
Alzheimer's Disease
Treatment
Lingual Strengthening
Saliva substitute
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-09-24
Enrollment: 152
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The overall purpose of this project is to develop effective dysphagia rehabilitative interventions for patients with Alzheimer's Disease and related dementias at risk for pneumonia development.

Detailed description: This proposal consists of a small, randomized clinical trial to determine the impact of two novel interventions on swallowing-related outcomes in patients with mild-moderate Alzheimer's Disease and Related Dementias (ADRD) and 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 only usual care. Saliva and swallowing-related outcomes will be collected at baseline and following the 8 week intervention period.

Consent and Randomization: Eligible dyads will be approached, consented and randomized at clinical care sites within University of Wisconsin Hospital and Clinics. Eligible participants' capacity to consent will determined by their primary clinical provider or team. Research staff will consent participant (or legally authorized representatives) prior to their swallow study. Each dyad will have equal chances of randomization to either usual care or one of the intervention arms plus usual care, with randomization stratified by the participant's dementia severity determined by the Clinical Dementia Rating (CDR) scale to ensure equal distribution of mild and moderate patients.

Baseline Assessment: Following randomization, the baseline assessment will be completed in tandem with the outpatient clinic visit. Staff will collect data on sociodemographics, comorbidities (using the Charlson comorbidity score approach) and medications (including anticholinergics and neuroleptics). The Montreal Cognitive Assessment (MoCA) will be administered at this time. Oral health status will be graded using the Brief Oral Health Status Examination, a valid and reliable scoring instrument developed for non-dental health care providers in long term care. Dentition will be characterized by the number of posterior occlusal pairs of teeth and denture use. Smoking history and active use during the study will be recorded.

Usual Care: Usual care group participants will receive standard swallowing interventions as recommended by the clinical Speech-Language Pathologist. Such treatment would likely consist of dietary (e.g., thickened liquids or pureed foods) or postural compensatory strategies (e.g., chin down posture while swallowing). All patient participants in intervention groups will also receive usual care, as indicated per their primary clinical team.

Interventions:

Saliva substitute: Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel. Participants will be instructed to apply an amount equivalent to about 1 cm of gel with a finger to the tongue and most intensely affected areas of the oral cavity three times a day for 8 weeks. Caregivers will be trained in how to assist the patient with application and support will be provided through follow-up phone calls.

Lingual strengthening intervention: Device training for dyads assigned to lingual strengthening will occur following randomization during the research visit. Isometric tongue strengthening will be completed using the Iowa Oral Performance Instrument (IOPI) over an 8-week program. An air-filled pressure bulb is placed on the surface of the oral tongue and pressed against the hard palate during exercise. Each patient is given a target pressure value to aim for as determined by the baseline one repetition maximum (1RM) lingual pressures. During week one of the regimen, the target value of each repetition will be 60% of the 1RM. For the remaining seven weeks, the target value will be increased to 80% of the 1RM. At weeks three, five, and seven, the baseline will be re-measured by phone and the 80% target value re-calculated. The final assessment point will be after completion of lingual strengthening. Training will be provided to both participants and caregivers on the device and lingual strengthening protocol and support will be provided to dyads through follow-up phone calls.

Eligibility criteria: Inclusion criteria (patients):

* Age 50-99
* English speaking
* Diagnosis of dementia or cognitive impairment or memory loss
* Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0
* Actively involved caregiver
* Resides at home, assisted living facility, or long-term care facility

Inclusion criteria (caregivers)

* English speaking
* Age 18 and older
* Contact with patient at least 1 time a week
* Has access to a working telephone

Exclusion criteria (patients):

* Dementia due to cerebrovascular disease as primary cause
* History of head and neck cancer or other structural deformity that can affect swallowing
* Allergy to barium
* Currently breastfeed or pregnant or planning to become pregnant

Exclusion criteria (caregivers):

* Lacks ability to give consent

Primary outcomes:
measure: Change in Pharyngeal residue measured with the Normalized Residue Ratio Scale (NRRS)
timeFrame: Baseline, Post-treatment at approximately 8 weeks
Secondary outcomes:
measure: Change in Modified Barium Swallow Impairment Profile (MBSImP) Overall Impairment Scores
timeFrame: Baseline, Post-treatment at approximately 8 weeks
measure: Change in Penetration-Aspiration Scale Scores
timeFrame: Baseline, Post-treatment at approximately 8 weeks
measure: Change in Lingual strength-maximal isometric lingual pressures
timeFrame: Baseline, Post-treatment at approximately 8 weeks
measure: Change in Functional Oral Intake Scale
timeFrame: Baseline, Post-treatment at approximately 8 weeks
measure: Change in Swallowing Quality of Life Questionnaire
timeFrame: Baseline, Post-treatment at approximately 8 weeks.
measure: Change in Zarit Burden Interview
timeFrame: Baseline, Post-treatment at approximately 8 weeks
measure: Change in Pneumonia diagnoses
timeFrame: Post-enrollment at approximately days 7, 14, 28, 42, 56, 90, and 180
measure: Change in Salivary Production Rates
timeFrame: Baseline, Post-treatment at approximately 8 weeks
measure: Change in Residual Mucosal Saliva (RMS)
timeFrame: Baseline, Post-treatment at approximately 8 weeks
measure: Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scores
timeFrame: Baseline, Post-treatment at approximately 8 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Nicole Rogus-Pulia, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
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