Oral health care intervention for elderly patients with dementia

ISRCTN ISRCTN48177484
DOI https://doi.org/10.1186/ISRCTN48177484
Secondary identifying numbers NHRI-107AI-PHCO-03181808
Submission date
08/06/2020
Registration date
06/07/2020
Last edited
01/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Oral care training for the elderly can help to reduce the rapid deterioration of oral diseases and the incidence of aspiration pneumonia, and further improve their health and quality of life. There is also an association between poor oral health status and cognitive impairment. This study aims to develop and apply a new method of basic oral hygiene care for the elderly with dementia, and evaluate the effectiveness of the intervention.

Who can participate?
Elderly with mild dementia who have at least four pairs of functional teeth

What does the study involve?
Participants will be randomly assigned to the experimental group or the control group. A one-on-one oral health education teaching activity will be conducted with experimental group members and their primary caregivers by a well-trained dental hygienist, including oral hygiene skill, chewing and swallowing practices, safe eating methods, dietary options, methods to reduce the risk of coughing, and oral function rehabilitation training. The participants will be encouraged to do it themselves at home at least once a day. Researchers will call experimental group participants twice a month by phone to check if they have problems with daily oral care. For those participants in the control group, participants are given a leaflet to read which includes general information about oral health. Before and after 3 and 6 months a questionnaire will be used to collect data on oral health care behaviours, oral hygiene, oral hygiene, and body mass index (BMI).

What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their oral health, oral function, and quality of life. Risks of participating in the study are low, participants may feel uncomfortable during the oral examination.

Where is the study run from?
Kaohsiung Medical University Hospital and Kaohsiung Municipal Ta-Tung Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
January 2018 to June 2021

Who is funding the study?
National Health Research Institutes (Taiwan)

Who is the main contact?
Prof. Hsiao-Ling Huang
hhuang@kmu.edu.tw

Contact information

Prof Hsiao-Ling Huang
Scientific

No.100
Shin-Chuan 1st Road
Sanmin Dist.
Kaohsiung City
80708
Taiwan

ORCiD logoORCID ID 0000-0002-1180-9011
Phone +886 (0)7 3121101 ext. 2159
Email hhuang@kmu.edu.tw

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format.
Scientific titleFollow-up study of oral health care and oral function intervention for elderly patients with dementia: a randomized controlled trial
Study objectivesThe basic oral health care and oral function intervention is an effective method for elderly patients with dementia.
Ethics approval(s)Approved 11/05/2018, Institutional review board of Kaohsiung Medical University Chung-Ho Memorial Hospital (No. 100, Tzyou 1st Road, Kaohsiung 807, Taiwan; +886 (0)7 3121101 ext. 6646; irb-training@kmuh.org.tw), ref: KMUHIRB-SV(I)-20180015
Health condition(s) or problem(s) studiedOral health of elderly patients with mild dementia (Clinical Dementia Rating=1.0)
InterventionIn this study, the elderly with mild dementia will be recruited in the Kaohsiung Medical University Hospital and Kaohsiung Municipal Ta-Tung Hospital. The physicians of Neurology Dementia outpatient clinic will recommend 200 suitable participants to the study. Participants will be randomly assigned using paper bags to the experimental group (EG) and control group (CG); each group has 100 participants.

A 30 minutes face-to-face teaching activity for EG participants and their caregivers was implemented by a well-trained dental hygienist. It concluded oral function promotion exercise and oral care methods, using a leaflet and dental models as teaching aids. Dental hygienist shared experiences with the participants and their caregivers, and consult immediately to improve the learning effect. The intervention aims to let the participants have sufficient oral care abilities at home, eat safely and effectively, reduce chewing and swallowing problems, obtain adequate nutrition, reduce the incidence of choking. In order to overcome the situation that many participants do not live with their children, or do not have a daily primary caregiver, special aids are designed. They were given to the participants to use at home, including: refrigerator magnets (remind to do oral function promotion exercise), stickers for bathroom mirror (reminder for oral cleaning), and "oral care logbook", provide participants to record their daily oral care activities. Moreover, the EG participants received one reminder phone call every 2 weeks from researcher.

For those participants in the CG, participants are given a leaflet to read which includes general information about oral health.

Pre-test for two groups will be done before. There are post-tests after 3 months and 6 months. A structured questionnaire will be used to collect data on oral health care behaviors, plaque index (PI), Winkel tongue coating index (WTCI), repetitive saliva swallowing test (RSST), measurement of the oral diadochokinetic (DDK), and body mass index (BMI). T-tests, Chi-square test, Fisher's exact test, and logistic regression will be used for analysis.
Intervention typeBehavioural
Primary outcome measure1. Oral hygiene measured using the Plaque Index (PI) and Winkel tongue coating index (WTCI) at pre-test and after 3 and 6 months
2. Oral function measured using the repetitive saliva swallowing test (RSST), oral diadochokinesis (DDK), perceived xerostomia and dysphagia scales at pre-test and after 3 and 6 months
3. Physical status measured using the Body Mass Index (BMI) at pre-test and after 3 and 6 months
Secondary outcome measuresOral health care behaviors measured using questionnaire at pre-test and after 3 and 6 months
Overall study start date01/01/2018
Completion date30/06/2021

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants200
Total final enrolment136
Key inclusion criteria1. Aged over 65 years
2. Diagnosis of mild dementia (Clinical Dementia Rating=1.0)
Key exclusion criteria1. Patients with post-stroke dementia
2. Smokers or betel quid chewers, or both users who have quit less than 6 months
3. Conditions that cause patients can not receive examination or intervention (such as blind, deaf)
4. Patients who have fewer than 4 pairs of functional teeth
Date of first enrolment14/06/2018
Date of final enrolment30/06/2020

Locations

Countries of recruitment

  • Taiwan

Study participating centres

Kaohsiung Medical University Chung-Ho Memorial Hospital
No.100, Tzyou 1st Rd, Sanmin Dist.
Kaohsiung City
80756
Taiwan
Kaohsiung Municipal Ta-Tung Hospital
No.68, Jhonghua 3rd Rd, Cianjin District
Kaohsiung City
80145
Taiwan

Sponsor information

National Health Research Institutes
Government

No. 35, Keyan Rd
Zhunan Town
Miaoli County
Miaoli County
35053
Taiwan

Phone +886 (0)37 206 166
Email webmaster@nhri.org.tw
Website http://english.nhri.org.tw/NHRI_WEB/nhriw001Action.do
ROR logo "ROR" https://ror.org/02r6fpx29

Funders

Funder type

Government

National Health Research Institutes (Taiwan)

No information available

Results and Publications

Intention to publish date31/12/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal. Additional documents are not available now.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 24/09/2022 01/11/2022 Yes No

Editorial Notes

01/11/2022: Publication reference added.
25/01/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2020 to 30/06/2021.
2. The intention to publish date was changed from 31/12/2021 to 31/12/2022.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
03/07/2020: IPD sharing statement added.
23/06/2020: Trial's existence confirmed by Institutional Review Board (IRB) of Kaohsiung Medical University Chung-Ho Memorial Hospital.