Interventions for Patients With Alzheimer's Disease and Dysphagia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Novel Rehabilitative Approaches for Dysphagia in Patients With Alzheimer's Disease and Related Dementias

Conditions
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Dementia, Dysphagia, Alzheimer Disease

Intervention / Treatment
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* Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)
* Device: Biotene Oral Balance Gel


Participation Criteria
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Eligibility Criteria
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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 or an assisted living 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Usual care groups will receive standard swallowing interventions identified by the Speech-Language Pathologist as appropriate to treat the patient's dysphagia and common in clinical practice. 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). No progressive lingual strengthening approaches or regimented salivary substitute protocols are utilized. | |
| Experimental: Saliva Substitute Intervention<br>Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel that will be applied to the oral cavity regularly for 8 weeks. | Device: Biotene Oral Balance Gel<br>* Participants will be instructed to apply an amount equivalent to about 1 cm of Biotene® Oral Balance Gel with a finger to the tongue and most intensely affected areas of the oral cavity three times a day after brushing their teeth for 8 weeks.<br>* Other names: Saliva substitute;|
| Experimental: Lingual Strengthening Intervention<br>Patient-caregiver dyads will be trained in the lingual strengthening protocol and patients will undergo this intervention for 8 weeks. Isometric tongue strengthening will be facilitated by the Iowa Oral Performance Instrument (IOPI) device. | Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)<br>* 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.<br>* Other names: Tongue strengthening;|
| Experimental: Saliva Substitute and Lingual Strengthening Intervention<br>Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel that will be applied regularly to the oral cavity for 8 weeks. Each dyad will also be trained in the lingual strengthening protocol and will undergo this intervention for 8 weeks. Isometric tongue strengthening will be facilitated by the Iowa Oral Performance Instrument (IOPI) device. | Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)<br>* 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.<br>* Other names: Tongue strengthening;Device: Biotene Oral Balance Gel<br>* Participants will be instructed to apply an amount equivalent to about 1 cm of Biotene® Oral Balance Gel with a finger to the tongue and most intensely affected areas of the oral cavity three times a day after brushing their teeth for 8 weeks.<br>* Other names: Saliva substitute;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pharyngeal residue measured with the Normalized Residue Ratio Scale (NRRS) | Pixel-based measure of post-swallow pharyngeal barium residue as observed on a videofluoroscopic swallow study captured at 30 frames per second. This measure will represent the amount of pharyngeal residue as it relates to the distance between cervical vertebrae 2 and 4 which serve as an anatomical scalar. A higher value represents more pharyngeal residue which is a worse outcome. | Baseline, Post-treatment at approximately 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Barium Swallow Impairment Profile (MBSImP) Overall Impairment Scores | Assessment of swallow function is completed though examination of 17 physiologic components requisite for the execution of normal swallowing. MBSImP includes an operationally defined scoring metric for each component that is applied to accurately describe and quantify progressing levels of impairment. Total possible range of scores is 0-62 with higher scores indicative of increased impairment. | Baseline, Post-treatment at approximately 8 weeks | 
| Change in Penetration-Aspiration Scale Scores | The penetration-aspiration scale, a validated scale used to measure the severity of airway invasion with swallowing, will be used with recordings of videofluoroscopic swallow studies. This is an 8-point scale with no airway invasion represented by a score of 1 and aspiration with no response represented by a score of 8. A higher score represents a worse outcome. | Baseline, Post-treatment at approximately 8 weeks | 
| Change in Lingual strength-maximal isometric lingual pressures | Maximum lingual pressures will be measured at the anterior and posterior locations of the tongue using the Iowa Oral Performance Instrument (IOPI). A higher value represents greater lingual pressure generation which is a better outcome. | Baseline, Post-treatment at approximately 8 weeks | 
| Change in Functional Oral Intake Scale | This is a validated scale used the quantify the level of oral versus nonoral intake as well as any dietary modifications needed. A score of 1 represents no oral intake with complete dependence on a feeding tube while a score of 7 represents total oral intake with no diet modifications. A higher score represents a better outcome. | Baseline, Post-treatment at approximately 8 weeks | 
| Change in Swallowing Quality of Life Questionnaire | The Swal-QOL is a validated questionnaire focused on swallowing-related quality of life. It comprises 10 multi-item scales, 2 general scales, and a 14-item symptom battery. Total possible range of scores is 0-100, higher scores represent better quality of life. | Baseline, Post-treatment at approximately 8 weeks. | 
| Change in Zarit Burden Interview | The Zarit Caregiver Burden Scale is used as a measure of caregiver psychological stress. The scores across all 22 items are summed and the range for the total score is from 0-88 with higher scores indicating greater burden (a worse outcome). | Baseline, Post-treatment at approximately 8 weeks | 
| Change in Pneumonia diagnoses | As an exploratory outcome, we will review the electronic health record for all pneumonia diagnoses (ICD-10 codes)for 180 days after enrollment in the study. A decrease in the number of pneumonia diagnoses represents improvement. | Post-enrollment at approximately days 7, 14, 28, 42, 56, 90, and 180 | 
| Change in Salivary Production Rates | Saliva production will be quantified through weighing collection tubes before and after unstimulated and stimulated saliva collection. A higher saliva weight represents a greater salivary flow rate and more saliva production. | Baseline, Post-treatment at approximately 8 weeks | 
| Change in Residual Mucosal Saliva (RMS) | RMS correlates with hyposalivation and dryness perception, will be collected from the anterior hard palate (AHP), anterior tongue (AT), and lower labial (LL) surfaces using SialoPaper strips (Oraflow Inc., Smithtown, NY, USA). These strips will be applied for 10 seconds and measured using Periotron device (Oraflow Inc.). | Baseline, Post-treatment at approximately 8 weeks | 
| Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scores | Assessment of swallow function is completed though analysis of videofluoroscopic images for swallowing safety and efficiency with the DIGEST tool. This is a validated method for identifying and rating penetration, aspiration, and residue, resulting in an overall score. DIGEST scores combine an evaluation of individual swallows to determine a safety grade of 0-4 with an efficiency grade of 0-4 to determine an overall DIGEST grade of 0 (no impairment) to 4 (profound impairment). | Baseline, Post-treatment at approximately 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Dysphagia, Alzheimer's Disease, Treatment, Lingual Strengthening, Saliva substitute