Effect of an Oral Frailty Measures Intervention Programs in Institutionalized Elders

ConditionFrailty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHangzhou Normal University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Edentulous state without dentures

Cognitive or communication impairments

Elderly lacking self-care ability

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

226 Participants
are divided into 2 treatment groups
Group A: Contral groupActive comparator 1 intervention
Group B: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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 \"not confident\" and 4 meaning \"very confident\". 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

Other outcomes

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