Effect of an Oral Frailty Measures Intervention Programs in Institutionalized Elders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: treatment group, Contral group.
- Who it may be relevant to
- Registry conditions: Frailty. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of an Oral Frailty Measures Program in Institutionalized Elders: a Study Protocol of a Cluster-Randomized Controlled Trial
Overview
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.
Interventions
- 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 interven - 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 ad
Primary outcome measures
- Assessing changes in the risk of oral frailty [Time frame: Before and 16 weeks after the intervention]
- Assessing changes in oral function status [Time frame: Before and 16 weeks after the intervention]
Secondary outcome measures (5)
- Assessment of changes in body composition [Time frame: Before and 16 weeks after the intervention]
- Nutrition Screening [Time frame: Before and 16 weeks after the intervention]
- Changes in Social Support [Time frame: Before and 16 weeks after the intervention]
- Self Efficacy [Time frame: Before and 16 weeks after the intervention]
- Changes in frailty [Time frame: Before and 16 weeks after the intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Edentulous state without dentures
- Cognitive or communication impairments
- Elderly lacking self-care ability
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Hangzhou Normal University — Hangzhou
Identifiers
NCT: NCT06536985 · 2024100