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Oral Health Education for Older Adults: Intentionality in Action

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial status changed: Enrolling by Invitation → Completed Show 4 more changesShow less
    • Final enrollment: 76 participants (planned 90)
    • Primary completion date changed from estimate of Jul 31, 2026 to Dec 17, 2025
    • Study completion date changed from estimate of Jul 31, 2026 to May 29, 2026
    • Eligibility criteria expanded, about 6 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07265726
Lead Sponsor Mackay Memorial Hospital
Conditions
(from sponsor)
Intentionality the Matrix of Healing, Community, Middle-aged and Older Adults, Oral Health Education
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov