Effect of an Oral Frailty Measures Intervention Programs in Institutionalized Elders

NCT06536985 | Not Yet Recruiting

• 1 other identifier: 2024100
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

This is a compelling 16-week prospective, double-blind, whole-cluster randomized controlled trial(RCT).This study will recruit 226 older adults over the age of 65.Based on King's goal attainment theory, a program to promote oral health is developed.The study aims to evaluate the effectiveness of a mixed face-to-face and eHealth oral health promotion program for older adults with oral frailty in nursing homes, based on the Theory of Planned Behavior.

Conditions

Frailty

Keywords

Nursing Homes; Aged; Exercise

Outcome Measures

Primary Outcomes (2)

• Assessing changes in the risk of oral frailty

  Oral frailty risk was assessed using the Chinese version of the Oral Frailty Index-8 (OFI-8 scale) translated by zongme.The scale consists of eight items with a total score ranging from 0 to 11, with higher scores indicating poorer oral health and higher risk of oral frailty. These include healthy (0-2 points), pre oral debilitation (3 points), oral debilitation (4-6 points) and severe oral debilitation (≥7 points).

  Before and 16 weeks after the intervention

• Assessing changes in oral function status

  We will use the Oral Frailty Assessment Instrument (OFI) created by Tanaka to measure the presence or absence of oral frailty and the detailed status of oral functioning to provide a basis for targeted interventions at a later stage. An assessment was made based on 6 items in the method described by Tanaka et al. These included the number of teeth, mastectomy function, articulation skills, tongue pressure, subjective feeding, and swallowing difficulty or not. Oral fragility was considered exist if at least 3 of the criteria were met. These included (1) Lower number of remaining teeth;(2) mastectomy score; (3) oral motor skills; (4) tongue pressure; (5) eating hard foods with subjective difficulty (yes); and (6) subjective dysphagia (yes). We used the Kihon questionnaire to ask about any difficulties with eating hard food and swallowing.

  Before and 16 weeks after the intervention

Secondary Outcomes (5)

• Assessment of changes in body composition

  Before and 16 weeks after the intervention

• Nutrition Screening

  Before and 16 weeks after the intervention

• Changes in Social Support

  Before and 16 weeks after the intervention

• Self Efficacy

  Before and 16 weeks after the intervention

• Changes in frailty

  Before and 16 weeks after the intervention

Study Arms (2)

Contral group

ACTIVE COMPARATOR

Behavioral: Contral group

Treatment group

EXPERIMENTAL

Behavioral: treatment group

Interventions

treatment group BEHAVIORAL

Researchers will collaborate with participants to develop personalized intervention plans, which include physical exercise, oral function training, basic dietary guidance, and detailed oral health knowledge directly related to oral health behaviors. To facilitate better communication and management, a WeChat group will be created to encourage participants to share their daily exercise achievements. In the first week, face-to-face oral function training sessions will be organized for the intervention group at the nursing home activity center. Concurrently, once a week, the intervention group will gather at the nursing home activity center to practice together using illustrated videos. On Wednesdays, educational articles and videos about oral health are sent via text message. On Fridays, a group communication activity is organized to enhance their social connections. Additionally, we will guide elderly participants to master essential internet skills, enabling them to use smartphones to

Treatment group

Contral group BEHAVIORAL

Participants in the control group will receive general lifestyle advice via text message once or twice a week.They will not participate in the intervention\'s fitness routines, online classes, group chats, or films with health educators. Individual workout regimens, goals, or comments are not given by researchers. Participants in the control group\'s complaints or questions will always be answered with basic health information and suggestions. Researchers won\'t ask for individual advice or comments from other professionals.

Contral group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years old
• Residing in a nursing home for ≥ 3 months
• Meeting at least three of the six criteria for oral frailty
• Conscious and with normal reading and comprehension abilities
• Informed consent to participate in this study

You may not qualify if:

• Edentulous state without dentures
• Cognitive or communication impairments
• Elderly lacking self-care ability

Sponsors & Collaborators

• Hangzhou Normal University: lead

Study Sites (1)

Hangzhou Normal University

Hangzhou, Zhejiang, 311121, China

Location

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Zhu HangTian

CONTACT

+8615372820009; 15372820009@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The first author will use randomizer.org for randomization. Recruitment without informing the subjects of study participation and group allocation to blind the subjects. And the allocation is also concealed for researchers in charge of data collection and processing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 5, 2024
• Study Start: November 11, 2024
• Primary Completion: August 11, 2025
• Study Completion: November 11, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)