Investigating Program of Food Preparation on Diet Improvement for Patients With Stroke

Stroke Clinical Trial

Official title:

Investigating Program of Food Preparation on Diet Improvement for Patients With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347863
• Other study ID #: 106-E-29
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Late Effect of Stroke
• Stroke

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