An interventional study of treatment group and Contral group in Frailty, sponsored by Hangzhou Normal University. Not yet recruiting at 1 site in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-04.
Sponsored by Hangzhou Normal University · Not applicable, Interventional, and Treatment
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.
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.
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 226 is above the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Contral group
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
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.
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).
Time frame: 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.
Time frame: Before and 16 weeks after the intervention
Assessment of changes in body composition
Participants will have body composition measured by using bioelectrical impedance analysis (BIA) with InBody 720 device.Detection content including: body weight (kg), skeletal muscle mass (kg), body fat mass (kg), BMI (kg/m2), body fat percentage (%) and waist--to--hip ratio).Participants will be told not to exercise for at least 24 hours before the test, not to consume alcohol or excessive amounts of caffeine, and not to eat and drink for four hours before the test, but water can be consumed up to 45 minutes before the test.
Time frame: Before and 16 weeks after the intervention
Nutrition Screening
We will use the Mini-Nutritional Assessment Short Form (MNA-SF) to assess the nutritional status of older adults in nursing facilities. The scale was created by Rubenstein et al. and includes six assessment categories: changes in food intake over the past three months, changes in body weight, mobility, acute illness or injury, psychosomatic problems, and body mass index (BMI). The scale goes up to 14 points. A score of 11 or higher is normal, while a score below 11 might indicate a risk of malnutrition. The Cronbach\'s alpha coefficient was 0.833, showing that the scale is reliable for assessing the nutritional status of elderly people because it has a high internal consistency.
Time frame: Before and 16 weeks after the intervention
Changes in Social Support
We will use the The Multidimensional Scale of Perceived Social Suppor（MSPSS） to measure social support levels. It was developed by Ziniet and revised by Keeley Zhou in China. There are three dimensions, including family support, other people\'s support, and friends\' support. The scale was scored on a 7-points Likert scale, with a total score of 12-84 points. According to the total scores of the scale, comprehension of social support was categorized into 3 levels, with 12-36 points as low level, 37-60 points as medium level, and 61-84 points as high level.
Time frame: Before and 16 weeks after the intervention
Self Efficacy
In this study, the Geriatric Self⁃Efficacy Scale for Oral Health (GSEOH) will be used to identify the current status of oral health self-efficacy of the subjects, which was developed by Ohara, et al. The GSEOH has 3 dimensions and 20 items. These dimensions are oral function (9 items) and oral health. They were developed by the University of California, Los Angeles. The scale has three dimensions and a total of 20 items. These dimensions are oral function (9 items), oral hygiene habits (8 items), and oral consultation habits (3 items). The scale uses a 4-point Likert scale, with 1 meaning \&#34;not confident\&#34; and 4 meaning \&#34;very confident\&#34;. The total scores can range from 20 to 80 points, or from 1 to 4 points. The higher the scores, the higher the oral health-related self-efficacy of the elderly.
Time frame: Before and 16 weeks after the intervention
Changes in frailty
The Groningen Frailty Indicator Scale will be used in this study to determine if patients are frail or not. The scale was developed by the Dutch scholar Steverink , and translated by Xiang Wei Frailty Scale, which evaluates the patients from multiple dimensions, including 4 dimensions of somatic, cognitive, psychological and social. Each of these entries is scored as "0" or "1" according to the score, and the total score ranges from 0 to 15. A larger score indicates a more severe degree of debilitation in the patient. The original scale uses a threshold value of 4. Patients with a score above 4 are considered debilitated.
Time frame: Before and 16 weeks after the intervention
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for Aug 2025, 9 months later.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 9 months is below that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Hangzhou Normal University