Clinical trial NCT05046210: The Effectiveness of Lay Health Advisors Strategy Intervention on Aborigines Elderly Oral Care Education
Official title: Oral Exercise With Lay Health Advisor Strategy on Oral Self-care Behaviors, Oral Hygiene, Oral Function and Quality of Life Among Older Adults in Aboriginal Communities in Taiwan: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Health
Keywords: Aboriginal
Lay Health Advisor
Oral Hygiene
Quality of Life
Oral Function
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 240
Sex: ALL
Minimum age (years): 55
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial (RCT) was conducted. The participants recruited from aboriginal communities in Eastern Taiwan. Data collecting time was from 2019 to 2020. Participants from the identified communities were randomly assigned to experimental group or control group using random table.
Primary purpose: PREVENTION

Brief summary: In the present study, the investigators aimed to evaluate the effectiveness of community-based oral exercise with LHA intervention on the oral health-related quality of life, oral function and oral self-care behaviors. This randomized controlled trial included LHA group (EG) and leaflet group (CG), respectively. The EG received a four-week one-on-one session by an LHA. Baseline and follow-up data collection were used to collect the data in oral Self-care behaviors, oral hygiene, oral function and quality of life.

Detailed description: A randomized controlled trial (RCT) was conducted. The participants recruited from aboriginal communities in Eastern Taiwan. Data collecting time was from 2019 to 2020. Participants from the identified communities were randomly assigned to EG or CG using random table. Participants who were 55 years old or above and indigenous people were recruited in the study. Participants who were disability, have had oral cancer, impaired facial appearance and impaired cognitive function were excluded. Impaired cognitive function was screening by Short Portable Mental Status Questionnaire (SPMSQ). Participants were recruited according to the predetermined minimal sample size estimated based on a type I error = 0.05, power = 0.95, and effect size (ES) f = 0.25 (medium effect in Cohen's f) . The number of samples in each group was expected 66 participants. An additional 30% drop out rate was added. The final number of samples for each group were required at least 86 participants. The total sample size was 122 and 118 in EG and CG, respectively. All participants underwent data collection at baseline and at 2-week, 3-and 6-month follow-ups.

Eligibility criteria: Inclusion Criteria:

* 55 years old or above and indigenous people

Exclusion Criteria:

* Disability, have had oral cancer, impaired facial appearance and impaired cognitive function were excluded.

Impaired cognitive function was screening by Short Portable Mental Status Questionnaire (SPMSQ).

Primary outcomes:
measure: Oral health-related quality of life
timeFrame: Change from baseline at 3-month and 6-month after intervention
measure: Swallowing
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: syllable /pa/, /ta/ and /ka/
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: Masticatory performance
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: Saliva flow rate
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: Perceived dysphagia
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: Plaque control record (PCR)
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: Plaque index (PI)
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: Winkel tongue coating index (WTCI)
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: Regular dental visit
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: Brushing ≥2 times/day
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: Use of interdental brushes
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
measure: Use of dental floss
timeFrame: Change from baseline at 2-week, 3-month and 6-month after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Hsiao-Ling Huang
role: PRINCIPAL_INVESTIGATOR
References: