NCT06536985

Effect of an Oral Frailty Measures Intervention Programs in Institutionalized Elders

Effect of an Oral Frailty Measures Program in Institutionalized Elders: a Study Protocol of a Cluster-Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: Hangzhou Normal University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Background: Oral frailty is a progressive loss of oral function associated with aging, usually caused by a variety of injuries. Some recent studies have shown that oral frailty is closely linked to physical functioning (physical frailty and changes in body composition), as well as nutritional status (low protein intake, poor dietary diversity, and malnutrition) in older adults in addition, a significant association between inadequate social network participation and poor oral function has also been confirmed by research. Oral frailty in older adults not only decreases their quality of life but also leads to serious problems like cognitive impairment, falls, disability, and even death. This puts a strain on families and society in terms of healthcare. Early Identifying and treating oral frailty is important for improving the quality of life of older adults and reducing the pressure on healthcare resources. Aim: The researchers hypothesize that a health program based on King\'s goal achievement theory will have a significant effect on oral frailty among older adults in nursing homes. Therefore, in this study, researchers will explore the impact of a health program based on King\'s goal achievement theory on oral frailty in older adults residing in nursing homes. Methods: This is a compelling 16-week prospective, double-blind, whole-cluster randomized controlled trial designed to evaluate a program aimed at enhancing oral health in older adults residing in nursing homes who experience oral frailty. The program combines in-person and online activities, aligning with the goal attainment theory. Once a week, the intervention group gathers 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 the elderly participants to master essential internet skills, use smartphones to stay in touch with friends and family, and provide timely feedback on issues through smartphones. Any reports or inquiries received through any channel will be promptly addressed. Participants and demographic data: Researchers will recruit patients with oral frailty from two welfare institutions in Hangzhou City in the following three main ways:1. Public information sessions: Information sessions were held in the activity centers of the nursing facilities to introduce the study to potential participants and encourage their participation. 2\. Local advertising: Posters and flyers were placed in the nursing facilities.3. Online recruitment: Recruitment information was posted using social media (WeChat), professional forums, and other online channels. Procedure and Data collection: This is a compelling 16-week prospective, double-blind, whole-cluster randomized controlled trial. The study adheres to the ethical principles of the Helsinki Declaration and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. It has been approved by the Medical Ethical Committee of Hangzhou Normal University（Ratification date is September 14 2024, 2024100） Statistical analysis: We used repeated measures two-way ANOVA to determine the effectiveness of independent intervention variables. The independent variables were group (intervention/control) and time (baseline/week 12). The dependent variable was the oral frailty measure. We examined the effects of program continuation using repeated measures two-way ANOVA and conducted post hoc testing using Bonferroni methods. All statistical analyses were performed using IBM SPSS Statistics for Windows version 24.0 (IBM Corp., Armonk, NY, USA). Statistically significant differences were defined as p-value \<0.05.

Conditions

• Frailty

Interventions

Type	Name	Description
BEHAVIORAL	treatment group	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
BEHAVIORAL	Contral group	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.

Timeline

• Start date: 2024-11-11
• Primary completion: 2025-08-11
• Completion: 2025-11-11
• First posted: 2024-08-05
• Last updated: 2024-11-04

Locations

1 site across 1 country: China