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Improved Modified Care Meals to Improving the Quality Of Life of the Pre-Frailty Chewing Disorders of the Older Adult

Primary Purpose

Food Selection, Quality of Life, Chewing Disease

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Texture Modified Foods Manual for chewing dysfunctions in older adult
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Food Selection

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • WangJiaJieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

Texture Modified Foods Manual for chewing dysfunctions (including IDDSI)

Traditional Soft Food Care Manual

Outcomes

Primary Outcome Measures

Geriatric oral health assessment index,GOHAI
Total score is 64 points, with higher scores indicating poorer oral health
Oral Health Assessment Tool ,OHAT
Total score is 16 points, with higher scores indicating poorer oral health
Oral health impact profile,OHIP
Total score is 56 points, with higher scores indicating poorer oral health
Meal satisfaction seven-item questionnaire
full score 35, minimum score 5 points.

Secondary Outcome Measures

Mini Nutritional Assessment - MNA Elderly,
Less than or equal to 7 points for malnutrition; 8-11 points for high-risk groups of malnutrition; 12 points for normal.

Full Information

First Posted
May 2, 2023
Last Updated
June 18, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05922098
Brief Title
Improved Modified Care Meals to Improving the Quality Of Life of the Pre-Frailty Chewing Disorders of the Older Adult
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
May 8, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Selection, Quality of Life, Chewing Disease, Satisfaction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Texture Modified Foods Manual for chewing dysfunctions (including IDDSI)
Arm Title
control group
Arm Type
No Intervention
Arm Description
Traditional Soft Food Care Manual
Intervention Type
Other
Intervention Name(s)
Texture Modified Foods Manual for chewing dysfunctions in older adult
Intervention Description
Texture Modified Foods Manual for chewing dysfunctions (including IDDSI)
Primary Outcome Measure Information:
Title
Geriatric oral health assessment index,GOHAI
Description
Total score is 64 points, with higher scores indicating poorer oral health
Time Frame
10-20mins
Title
Oral Health Assessment Tool ,OHAT
Description
Total score is 16 points, with higher scores indicating poorer oral health
Time Frame
10-20mins
Title
Oral health impact profile,OHIP
Description
Total score is 56 points, with higher scores indicating poorer oral health
Time Frame
10-20mins
Title
Meal satisfaction seven-item questionnaire
Description
full score 35, minimum score 5 points.
Time Frame
5-10mins
Secondary Outcome Measure Information:
Title
Mini Nutritional Assessment - MNA Elderly,
Description
Less than or equal to 7 points for malnutrition; 8-11 points for high-risk groups of malnutrition; 12 points for normal.
Time Frame
5-10mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang JiaJie
Phone
+886 965073193
Email
mswing97@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang JiaJie
Official's Role
Principal Investigator
Facility Information:
Facility Name
WangJiaJie
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JiaJie
Phone
0965073193
Email
mswing97@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Improved Modified Care Meals to Improving the Quality Of Life of the Pre-Frailty Chewing Disorders of the Older Adult

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