Clinical trial NCT05407532: Effectiveness of Oral Management Strategies on Improving Oral Frailty and Oral Bacteria
Official title: Effectiveness of Oral Management Strategies on Improving Oral Frailty and Oral Bacteria Among Middle-aged and Elderly Hospitalized Adults With Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
Pneumonia, Bacterial
Keywords: Pneumonia
Oral frailty
Oral bacteria
Oral management
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 90 patients will be recruited and randomly assigned to three groups: the oral care group, the oral management group, and the standard care group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to examine the effectiveness of nurse-driven oral management for improvements of oral frailty, and oral bacteria pneumonia patients with oral frailty using a randomized controlled trial (RCT) design. Hospitalized pneumonia patients (N = 90) will be randomized into three groups (oral management, oral care, and standard of care). The primary outcomes include the oral frailty measures determined by seven-item included oral hygiene, oral dryness, occlusion force, tongue-lip motor function, tongue pressure, mastication function, and swallowing function. Saliva samples were collected from the oral cavity before the bacterial culture was performed in the laboratory. Oral frailty measures and the presence of bacterial exposure were evaluated at baseline (1st day), on days 5, and at the time of discharge. The investigators will perform statistical analyses according to the intention-to-treat principle. All missing values will be imputed using the last value carry-forward method. The between-group differences will be examined using a mixed model in which group and time interaction will be included. This study finding could provide oral management strategies that could improve oral frailty and decrease oral bacteria for preventing recurrent pneumonia infection among middle-aged and older adults with pneumonia.

Detailed description: The inclusion criteria will be as follows: (1) patients should be ≥ 50 years old; (2) patients' oral frailty should have been diagnosed with pneumonia, and (3) patients should have a Glasgow coma index of 15 points and be able to cooperate. Alternatively, the exclusion criteria will be as follows: (1) people with healthcare-related pneumonia; (2) those with head and neck cancer; or (3) those having an abnormal oral structure.

Eligibility criteria: Inclusion Criteria:

* Older than 50 years of age and equal
* Having mental clarity (Glasgow coma scale: 15)

Exclusion Criteria:

* A brief hospitalization (≤ 3 days) for non-acute care, such as uncomplicated elective percutaneous coronary intervention;
* Acute psychiatric syndromes;
* Received dental treatment in the last 6 months.

Primary outcomes:
measure: oral frailty measures
timeFrame: The first day of admission (baseline value)
measure: Clearance of pneumonia associated oral bacteria
timeFrame: The first day of admission (baseline value)
measure: oral frailty measures
timeFrame: Day 5 of admission
measure: oral frailty measures
timeFrame: Discharge day
measure: Clearance of pneumonia associated oral bacteria
timeFrame: Discharge day
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
state: Taiwan (r.o.c)
Study officials:
affiliation: National Cheng-Kung University Hospital
name: I-Yin Ho
role: STUDY_CHAIR
References:
citation: Chiang TC, Huang MS, Lu PL, Huang ST, Lin YC. The effect of oral care intervention on pneumonia hospitalization, Staphylococcus aureus distribution, and salivary bacterial concentration in Taiwan nursing home residents: a pilot study. BMC Infect Dis. 2020 May 27;20(1):374. doi: 10.1186/s12879-020-05061-z.
citation: Minakuchi S, Tsuga K, Ikebe K, Ueda T, Tamura F, Nagao K, Furuya J, Matsuo K, Yamamoto K, Kanazawa M, Watanabe Y, Hirano H, Kikutani T, Sakurai K. Oral hypofunction in the older population: Position paper of the Japanese Society of Gerodontology in 2016. Gerodontology. 2018 Dec;35(4):317-324. doi: 10.1111/ger.12347. Epub 2018 Jun 8.