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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04347863
Other study ID # 106-E-29
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2018
Est. completion date September 28, 2018

Study information

Verified date April 2020
Source Taiwan Adventist Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of food preparation on diet improve patients with stroke.


Description:

This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of food preparation on diet improve patients with stroke. Subjects will be randomized to intervention group and control group.The primary outcome included seven measures, Functional oral intake scale, Mini Nutritional Assessment, Council on Nutrition Appetite Questionnaire, Dietary Well-Being Scale, Swallowing Quality of Life questionnaire, WHO Quality of Life-BREF and Eating Assessment Tool-10.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date September 28, 2018
Est. primary completion date September 28, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Diagnosis is stroke

- EAT-10 = 3

- Aged > 20 years

- Capability of following instructions

- Willing to participants to the study

Exclusion Criteria:

- Non-stroke neurological diseases ( ex: traumatic brain injury, brain tumor, neurodegenerative disease and Parkinson's disease )

- Dysphagia by neck injury or surgery

- During the study, he/she was hospitalized again due to disease.

Study Design


Intervention

Other:
Group swallowing disorder diet preparation program
This program included food properties, select food, type of cooking, using thickener and tasting

Locations

Country Name City State
Taiwan National Taipei University of Nursing and Health Sciences Taipei City Beitou Dist

Sponsors (1)

Lead Sponsor Collaborator
Taiwan Adventist Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of the Eating Assessment Tool-10 Eating Assessment Tool-10 assesses ability of swallowing by myself. The total scare ranges from 0-40. A higher level indicates better ability of swallowing. Changes of the Eating Assessment Tool-10 will be assessed before and after intervention. 6 weeks
Primary Changes of the Functional Oral Intake Scale Functional Oral Intake Scale assesses ability of swallowing. The total level ranges from 1-7. A higher level indicates better ability of swallowing. Changes of the Functional Oral Intake Scale will be assessed before and after intervention. 6 weeks
Primary Changes of the Mini Nutritional Assessment Mini Nutritional Assessment assesses comprehensive nutritional. The total score ranges from 0-30. A higher score indicates better nutrition status. Changes of the Mini Nutritional Assessment will be assessed before and after intervention. 6 weeks
Primary Changes of the Council on Nutrition Appetite Questionnaire Council on Nutrition Appetite Questionnaire assesses appetite.The total score ranges from 8-40. A higher score indicates better appetite. Changes of the Council on Nutrition Appetite Questionnaire will be assessed before and after intervention. 6 weeks
Primary Changes of the Dietary Well-Being Scale Dietary Well-Being Scale assesses dietary well-being. The total scare ranges from 21-126. A higher score indicates better dietary well-being. Changes of the Dietary Well-Being Scale well be assessed before and after intervention. 6 weeks
Primary Changes of the Swallowing Quality of Life questionnaire Swallowing Quality of Life questionnaire assesses quality of life about swallowing.The total score ranges from 44-220. A higher score indicates better quality of life about swallowing. Changes of the Swallowing Quality of Life questionnaire well be assessed before and after intervention. 6 weeks
Primary Changes of the WHO Quality of Life-BREF WHO Quality of Life-BREF assesses quality of life. The total score ranges from 28-140. A higher score indicates better quality of life. Changes of the WHO Quality of Life-BREF well be assessed before and after intervention. 6 weeks
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