Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Educación en Salud Oral para Adultos Mayores: Intencionalidad en Acción

20 de septiembre de 2026 actualizado por: Mackay Memorial Hospital

Explorando la efectividad de la intencionalidad de la Matriz de Sanación para mejorar los resultados de la educación en salud bucal en adultos de mediana edad y mayores que viven en la comunidad

After obtaining approval from the Institutional Review Board (IRB), the clinical trial will be registered on a designated trial registration website. Participant recruitment will be conducted online. For individuals who meet the inclusion criteria and express interest, the principal investigator will verbally explain the study protocol, go over the informed consent form, and answer any related questions. Potential participants who meet the inclusion criteria and are willing to participate will be given time to consider their involvement in the study.

Inclusion criteria for this study are:

  1. Adults aged 40 and older
  2. Ability to hear, speak, and read Chinese, and communicate fluently in Mandarin or Taiwanese.

Exclusion criteria include:

  1. Being completely edentulous and not using dentures;
  2. Having severe food allergies, renal failure, or dysphagia;
  3. Being diagnosed with terminal illness under palliative care, severe mental illness, or cognitive impairment;
  4. Having a serious health condition that prevents standing or performing oral self-care behaviors.

Upon receiving verbal agreement from potential participants, the study procedure and the contents of the consent form will be explained again. This is a parallel randomized experimental study, with an estimated sample of 90 middle-aged and older adults recruited from the community through online means. Participants will be randomly assigned to one of three groups:

  1. intentional interviews combined with expressive arts activities,
  2. expressive arts activities only, or
  3. control group.

All three groups will receive oral health education before the intervention and six weeks after the intervention. Questionnaire surveys will be conducted one week and one month post-education to collect data on sarcopenia risk, eating assessment, grit, oral health literacy, and oral self-care behaviors. Statistical analyses will be performed on the collected data.

Participants who fully understand the study and agree to participate will sign an informed consent form. Two copies of the consent form will be prepared-one will be kept by the principal investigator, and a photocopy will be given to the participant for personal recordkeeping. Participants retain the right to decline or withdraw from the study at any time, even after signing the consent form. Their withdrawal will not affect their future rights, benefits, or services, and any previously collected data will be deleted upon request.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

76

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New Taipei City
      • New Taipei City, New Taipei City, Taiwán
        • Sanzhi

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años a 100 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Individuals aged 40 years or older (Vlietstra et al., 2024).
  2. Ability to hear, speak, and read Chinese, with no communication barriers in Mandarin or Taiwanese.

Exclusion Criteria:

  1. Edentulous individuals who do not use dentures.
  2. Individuals with severe food allergies, renal failure, or dysphagia.
  3. Individuals diagnosed with terminal illness under palliative care, severe psychiatric disorders, or cognitive impairments.
  4. Individuals with serious medical conditions that prevent standing or performing oral self-care behaviors.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control Group

Participants in the control group will not receive any intentional interview or expressive arts activity during the 6-week intervention period. They will receive oral health education after the same time interval as the experimental arms, ensuring consistency in outcome measurement.

Comparador activo: Expressive Arts Activities Only

Participants in this arm will engage only in expressive arts activities over a 6-week period. These activities are designed to foster creative engagement and emotional well-being. After the intervention, participants will receive the same oral health education provided to all groups.

Participants in this arm will receive an intervention

Experimental: Intentional Interview + Expressive Arts Activities

Participants in this arm will receive an intervention combining an intentional interview based on the Intentionality Matrix of Healing framework with expressive arts activities. The intentional interview is designed to guide participants in reflecting on personal health-related intentions, while the expressive arts component facilitates emotional expression and engagement. After the 6-week intervention, all participants will also receive standardized oral health education.

Participants in this arm will receive an intervention

Participants in this arm will engage only in expressive arts activities over a 6-week period.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
sarcopenia risk
Periodo de tiempo: baseline, one week after the intervention, and at a one-month follow-up

This study adopted the SARC-F questionnaire proposed by the Asian Working Group for Sarcopenia (AWGS). The tool consists of five questions aimed at assessing muscle function, including grip strength, endurance, walking ability, ability to stand up from a chair, and fall history in the past six months (Ishida et al., 2020). The first four items are scored based on the responses: no difficulty (0 points), some difficulty (1 point), and a lot of difficulty (2 points). The fifth item, fall history, is scored as follows: 0 falls = 0 points, 1-3 falls = 1 point, and 4 or more falls = 2 points. The total score ranges from 0 to 10, with higher scores indicating a greater risk of sarcopenia. A SARC-F score of 4 or higher suggests a positive result for self-screening, indicating the need for further medical evaluation and appropriate diagnostic and treatment interventions.

The sensitivity, specificity, and positive/negative likelihood ratios of the SARC-F for predicting sarcopenia and its risk

baseline, one week after the intervention, and at a one-month follow-up
eating assessment
Periodo de tiempo: baseline, one week after the intervention, and at a one-month follow-up

This study utilized the Eating Assessment Tool-10 (EAT-10), a dysphagia screening tool included in the adult oral health assessment form issued by the Department of Oral Health, Ministry of Health and Welfare. The version used is the Chinese translation by Huang (2023) of the original tool developed by Belafsky et al. (2008). The EAT-10 consists of 10 items that assess self-perceived difficulties related to swallowing, encompassing physical, psychological, and social aspects. Example items include: "Swallowing problems have caused me to lose weight" and "Swallowing interferes with my ability to go out for meals." The scale has demonstrated good reliability and validity, with a Cronbach's alpha coefficient of 0.92. The total score ranges from 0 to 40, with a score of ≥3 indicating the presence of swallowing difficulties. Higher scores reflect a greater risk of oral frailty.

baseline, one week after the intervention, and at a one-month follow-up
grit
Periodo de tiempo: baseline, one week after the intervention, and at a one-month follow-up

This study adopted the Chinese version of the Grit Scale (Grit-10) developed by Duckworth et al. (2009). The scale consists of 10 items across two main factors: passion (reverse-scored items) and perseverance. Example items include: "I often set a goal but later choose to pursue a different one" (passion, reverse-scored) and "I finish whatever I begin" (perseverance). The scale uses a 5-point Likert rating system, ranging from 1 (not at all like me) to 5 (very much like me).

Scoring is as follows: each item has a maximum score of 5. Odd-numbered items are reverse scored, and even-numbered items are positively scored. The total score of the odd-numbered items divided by 5 gives the passion subscale score, while the total score of the even-numbered items divided by 5 gives the perseverance subscale score. The sum of all 10 items divided by 10 yields the overall grit score.

Lin (2019) applied this Chinese version to university students and reported a Cronbach's alpha of 0.84 for the ov

baseline, one week after the intervention, and at a one-month follow-up
oral health literacy
Periodo de tiempo: baseline, one week after the intervention, and at a one-month follow-up

This study adopted the short-form Health Literacy Dental Scale (HeLD-14) developed by Jones et al. (2015), which has a Cronbach's alpha of 0.87. The scale was translated into Simplified Chinese by Liu et al. (2021) (Chinese version of HeLD, HeLD-C), showing a Cronbach's alpha of 0.92, and was later adapted into a Traditional Chinese version by Cheng (2023). The Traditional Chinese version includes 13 items across seven domains:

Receptivity (e.g., "I care about my dental or oral health needs"),

Understanding (e.g., "I can fill out dental-related forms"),

Support (e.g., "I can bring family members or friends to dental visits"),

Economic Barriers (e.g., "I can afford the cost of dental or oral health care"),

Utilization (e.g., "I know how to make a dental appointment"),

Communication (e.g., "I can obtain alternative oral health opinions from other dentists"), and

Access to Resources (e.g., "I can follow the dentist's instructions").

The scale uses a 5-point Likert rating system r

baseline, one week after the intervention, and at a one-month follow-up
oral self-care behaviors
Periodo de tiempo: baseline, one week after the intervention, and at a one-month follow-up

This study adopted the Oral Self-Care Behavior Scale revised by Cheng (2023), originally developed by Ho, Rita Chang et al. (2019). The scale consists of 10 items; example statements include: "I brush my teeth at least twice a day" and "I always brush my teeth before going to bed at night." A 4-point Likert scale is used, ranging from 1 (not at all) to 4 (completely). The total score ranges from 10 to 40, with higher scores indicating better oral self-care behavior. The Cronbach's alpha ranges from 0.78 to 0.87 (Cheng, 2023), demonstrating good reliability.

baseline, one week after the intervention, and at a one-month follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de julio de 2025

Finalización primaria (Actual)

17 de diciembre de 2025

Finalización del estudio (Actual)

29 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2025

Primero enviado que cumplió con los criterios de control de calidad

24 de noviembre de 2025

Publicado por primera vez (Actual)

5 de diciembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de septiembre de 2026

Última verificación

1 de diciembre de 2025

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 25MMHIS120e

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir