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Change of scope of the work given feedback from funding agency leading to new IRB/clinicaltrials.gov registration.
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Post-intensive care syndrome (PICS), which consists of physical, cognitive, and psychosocial problems, is a pervasive complication for older intensive care unit (ICU) survivors and contributes to detrimental health outcomes and significant reductions in quality of life. Yet, little is known about the relationship between PICS, swallowing difficulties (dysphagia), and other ICU-related negative outcomes such as frailty and Alzheimer's Disease and Related Dementias (ADRD). The primary purpose of this research study is to determine the prevalence and severity of dysphagia, risk factors for dysphagia development, recovery patterns of dysphagia over time, and the impact of dysphagia on health outcomes, quality of life, and care partner burden in adult ICU survivors with PICS.
This study will involve one in-person research visit for community dwelling adults and two research visits for critically ill adults (one in the ICU, one 3-months post-hospital discharge) that will last approximately 1 hour and will consist of a screening, cough testing, swallow function testing, assessments of hand grip and tongue strength, and completion of questionnaires. Caregivers of ICU survivors will complete questionnaires at the 3-month follow up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy community dwelling adults | Healthy community dwelling adults who meet the inclusion criteria for the study will be enrolled. | ||
| ICU survivors and their care partners | Critically ill adults and their care partners who meet inclusion criteria for the study will be enrolled. |
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| Measure | Description | Time Frame |
|---|---|---|
| Swallowing safety and efficiency | The validated Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale will be used to measure swallowing safety and efficiency. | During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults. |
| Measure | Description | Time Frame |
|---|---|---|
| Voluntary cough peak expiratory flow | A measure of cough strength | During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults. |
| Grip strength |
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Inclusion criteria community-dwelling adults:
Exclusion criteria community-dwelling adults:
Inclusion criteria critically-ill adults:
Exclusion criteria critically ill adults:
Inclusion criteria caregivers:
Exclusion criteria caregivers:
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We will enroll 100 community dwelling adults who meet inclusion criteria, 180 critically ill adults who meet inclusion criteria, and 180 caregivers of critically ill adults who meet inclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| C000657744 | postintensive care syndrome |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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Grip strength be used to quantify clinical frailty using a digital hand dynamometer. |
| During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults. |
| Tongue strength | Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI). | During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults. |
| Swallowing and Eating Related Fatigue Questionnaire (SERF) | Scores on the SERF range 0-48 with higher scores indicating greater impairment. | During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults. |
| Eating Assessment Tool 10 (EAT-10) | The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment. | During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults. |
| 3 oz water swallow test | Participants will be given a cup of three ounces of water and instructed to drink the water continuously. Fail criteria includes interrupted drinking and/or coughing/throat clearing during or immediately following the drinking task. | During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults. |
| Reflex cough | Participants will undergo reflex cough testing. | During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults. |
| Screening for Oral Frailty Tool (SOFT) | Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool. | During baseline visit at time of enrollment for community dwelling adults. During baseline visit at time of enrollment and 3 months post-hospital discharge for critically ill adults. |
| Swallowing Related Quality of Life Questionnaire (SWAL-QOL) | Scores on the SWAL-QOL range from 0-100 with lower scores indicating greater impairment. | During baseline visit at time of enrollment for community dwelling adults. 3 months post-hospital discharge for critically ill adults. |
| Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire | Scores on the CARES range from 0-26 with higher scores indicating greater caregiver burden. | 3 months post-hospital discharge for care partners of critically ill adults. |
| D010038 | Otorhinolaryngologic Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |