Stroke Clinical Trial
Official title:
The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke
NCT number | NCT04095780 |
Other study ID # | 81701036 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2018 |
Est. completion date | June 1, 2021 |
Verified date | July 2022 |
Source | Anhui Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the evidence for the integration of oral health promotion as part of interdisciplinary stroke rehabilitation.
Status | Completed |
Enrollment | 166 |
Est. completion date | June 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - having onset of stroke within 3 days and free of any post-stroke complication - having moderate to severe functional disability- Barthel Index (BI) scores of <70 - being conscious and respiring voluntarily without ventilator - not having any lung disease and lower respiratory infection - not have an indwelling naso-gastric feeding tubes - having dysphagia as showed by GUSS test (The Gugging Swallowing Screen, GUSS) - having normal cognitive ability or mild impairment- Mini Mental State Examination (MMSE) >18 - having ability to follow instruction (as an assessment of compliance of oral health intervention) - not having systemic administration of antibiotics - not being edentulous Exclusion Criteria: - mild disability (Barthel Index > 70) - having normal swallowing function - edentulous - having an indwelling naso-gastric feeding tubes - having communication disorders, unable to cooperate with family caregivers for oral health promotion |
Country | Name | City | State |
---|---|---|---|
China | The Second People's Hospital of Hefei | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
Anhui Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The prevalence of pneumonia complicating stroke | To calculate and compare the incidence of pneumonia between interventional group and control group, to identify whether the intervention approach could reduce the short-term incidence after the baseline. | 1 week | |
Secondary | The prevalence of pneumonia complicating stroke | To calculate and compare the long-term incidence of pneumonia between interventional group and control group. | 1 month, 3 months, 6 months | |
Secondary | Metagenomic | To analyze composition and relative abundance of oral microbiome in oral rinse samples. | 3 days, 5 days, 7 days, and 1 month, 3 months, 6 months | |
Secondary | Plaque Index | 0 = no plaque detected with probe; 1 = plaque not visible by unaided eye but detectable with probe; 2 = moderate amount of plaque; 3 = abundance of plaque | 1 month, 3 months, 6 months | |
Secondary | Gingival Bleeding Index | 0 = no bleeding after probing; 1 = presence of bleeding within 10 seconds after probing. | 1 month, 3 months, 6 months | |
Secondary | the Short Form Health Survey 12 (SF-12) | The SF-12 consists of 12 items covering eight conceptual domains of health: general health (GH), physical functioning (PF), bodily pain (BP), role-physical (RP), mental health (MH), vitality (VT), social functioning (SF), and role-emotional (RE). Four items are reversed for scoring (item no.: 1, 8, 9, and 10). The SF-12 consists of 12 items and each of them has its own physical component summary (PCS) and mental component summary (MCS) regression coefficients. The response to each item will be multiplied by its PCS regression coefficient and added together with the PCS constant to provide Physical Health summary scores (SF-12 PCS). Mental Health summary scores (SF-12 MCS) will be calculated likewise. A higher scores mean a better outcome. | 1 month, 3 months, 6 months | |
Secondary | the Oral Health Impact Profile 14 (OHIP-14) | 0=never, 1=hardly ever, 2=occasionally, 3=fairly often, and 4=very often/all of the time. Summary OHIP-14 score and domain scores will be derived by summating responses to each item (i.e. score 2, 3, and 4). A higher scores mean a worse outcome. | 1 month, 3 months, 6 months | |
Secondary | the Geriatric Oral Health Assessment Index (GOHAI) | 1 = always, 2 = often, 3 = sometimes, 4 = seldom, and 5= never. Summary GOHAI scores will be derived by summating responses to items after reversing the coding of the three positively worded items (swallowing, appearance, and discomfort when eating). A higher scores mean a better outcome. | 1 month, 3 months, 6 months |
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