Clinical trial NCT06536985: Effect of an Oral Frailty Measures Intervention Programs in Institutionalized Elders
Official title: Effect of an Oral Frailty Measures Program in Institutionalized Elders: a Study Protocol of a Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty
Keywords: Nursing Homes
Aged
Exercise
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 226
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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\&amp;amp;#39;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\&amp;amp;#39;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 \&amp;lt;0.05.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Edentulous state without dentures
2. Cognitive or communication impairments
3. Elderly lacking self-care ability

Primary outcomes:
measure: Assessing changes in the risk of oral frailty
timeFrame: Before and 16 weeks after the intervention
measure: Assessing changes in oral function status
timeFrame: Before and 16 weeks after the intervention
Secondary outcomes:
measure: Assessment of changes in body composition
timeFrame: Before and 16 weeks after the intervention
measure: Nutrition Screening
timeFrame: Before and 16 weeks after the intervention
measure: Changes in Social Support
timeFrame: Before and 16 weeks after the intervention
measure: Self Efficacy
timeFrame: Before and 16 weeks after the intervention
measure: Changes in frailty
timeFrame: Before and 16 weeks after the intervention
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Normal University
state: Zhejiang
Study officials:
References: