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

Kaohsiung Medical University

Status: Completed

Conditions: Oral Health

Treatments: Behavioral: LHA intervention; Behavioral: Oral exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05046210

NHRI-108A1-PHCO-03191908 (Other Grant/Funding Number)

KMUHIRB-SV(I)-20190010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 55 to 82 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

240 participants in 2 patient groups, including a placebo group

LHA group (EG)

Experimental group

Description:

Behavioral: LHA intervention Oral exercise intervention is designed to increase the range of movement in tongue, lips, and jaw as well as salivary gland massages, which will help speech and/or swallow functioning. All participants performed oral exercise before three meals a day, whereas the participants in the EG also received 4 lessons from a LHA over 4 weeks.

Treatment:

Behavioral: LHA intervention

Behavioral: Oral exercise intervention

Leaflet group (CG)

Placebo Comparator group

Description:

Oral exercise intervention is designed to increase the range of movement in tongue, lips, and jaw as well as salivary gland massages, which will help speech and/or swallow functioning. All participants performed oral exercise before three meals a day. The participants in the CG received oral exercise intervention and leaflets only.

Treatment:

Behavioral: Oral exercise intervention