- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05922098
Improved Modified Care Meals to Improving the Quality Of Life of the Pre-Frailty Chewing Disorders of the Older Adult
To Explore the Effect of Improved Modified Care Meals to Improving the Quality Of Life of the Pre-Frailty Chewing Disorders of the Older Adult
In 2020, we have entered an aging society. During the aging process, the body will decline with age, and the muscles will decrease, which will affect the swallowing muscles, causing chewing and swallowing difficulties are very common. Difficulty masticating is associated with problems with real teeth, dentures, and oral health disease, and is associated with infection, pain, inadequate nutritional intake, affected appearance, decreased quality of life, and mortality.
At present, Taiwan mostly provides the elderly with shredded food, cooked soft and rotten food, or whipped food. However, when the food is mashed or shredded, the original color, fragrance, and taste of the food will be lost. It cannot change the appetite of the elderly, and it will reduce the satisfaction of the elderly's meal, and there will still be risks of insufficient food intake and uneven nutrition. Appearance or taste can improve the satisfaction and quality of life of the elderly, improve the health needs of nutrition, and allow a variety of choices when eating to change the current situation of traditional whipped food and shredded meals.It is expected that the quality of life, nutritional status, and meal satisfaction of the pre-frail elders with masticatory difficulties will be significantly higher than those of the control group if the subjects receive care meals, which can be used as a reference for the daily care of the elderly with masticatory disorders in the future.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wang JiaJie
- Phone Number: +886 965073193
- Email: mswing97@gmail.com
Study Locations
-
-
-
Hualien City, Taiwan, 970
- Recruiting
- WangJiaJie
-
Contact:
- JiaJie
- Phone Number: 0965073193
- Email: mswing97@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Elderly over 65 years old.
- Elders who are pre-frail cases after the five assessments of frailty and who are abnormal after the chewing test.
- Clear awareness, willing to accept visitors, able to communicate in Chinese and Taiwanese.
- Ability to express food appearance and taste.
- Those who eat by mouth.
Exclusion Criteria:
- Elderly with dementia (certified by medical records and disability handbook).
- Elderly people who have swallowing disorders in the throat stage after being screened by the modified water swallowing test.
- Visually impaired and no primary caregiver to assist the program implementer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
Texture Modified Foods Manual for chewing dysfunctions (including IDDSI)
|
Texture Modified Foods Manual for chewing dysfunctions (including IDDSI)
|
No Intervention: control group
Traditional Soft Food Care Manual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geriatric oral health assessment index,GOHAI
Time Frame: 10-20mins
|
Total score is 64 points, with higher scores indicating poorer oral health
|
10-20mins
|
Oral Health Assessment Tool ,OHAT
Time Frame: 10-20mins
|
Total score is 16 points, with higher scores indicating poorer oral health
|
10-20mins
|
Oral health impact profile,OHIP
Time Frame: 10-20mins
|
Total score is 56 points, with higher scores indicating poorer oral health
|
10-20mins
|
Meal satisfaction seven-item questionnaire
Time Frame: 5-10mins
|
full score 35, minimum score 5 points.
|
5-10mins
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini Nutritional Assessment - MNA Elderly,
Time Frame: 5-10mins
|
Less than or equal to 7 points for malnutrition; 8-11 points for high-risk groups of malnutrition; 12 points for normal.
|
5-10mins
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wang JiaJie
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WangJiaJie
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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