The Effectiveness of Lay Health Advisors Strategy Intervention on Aborigines Elderly Oral Care Education

Oral Health Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Oral Health

• NCT number: NCT05046210
• Study type: Interventional
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Completion date: February 3, 2021