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

Primary Purpose

Stroke, Dysphagia, Late Effect of Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Group swallowing disorder diet preparation program
Sponsored by
Taiwan Adventist Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Food preparation, Dietary well-being, Quality of life, Dysphagia, Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taipei University of Nursing and Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Group swallowing disorder diet preparation program

No Intervention

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 13, 2020
Last Updated
April 13, 2020
Sponsor
Taiwan Adventist Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04347863
Brief Title
Investigating Program of Food Preparation on Diet Improvement for Patients With Stroke
Official Title
Investigating Program of Food Preparation on Diet Improvement for Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Adventist Hospital

4. Oversight

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

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dysphagia, Late Effect of Stroke
Keywords
Food preparation, Dietary well-being, Quality of life, Dysphagia, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Group swallowing disorder diet preparation program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No Intervention
Intervention Type
Other
Intervention Name(s)
Group swallowing disorder diet preparation program
Intervention Description
This program included food properties, select food, type of cooking, using thickener and tasting
Primary Outcome Measure Information:
Title
Changes of the Eating Assessment Tool-10
Description
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.
Time Frame
6 weeks
Title
Changes of the Functional Oral Intake Scale
Description
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.
Time Frame
6 weeks
Title
Changes of the Mini Nutritional Assessment
Description
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.
Time Frame
6 weeks
Title
Changes of the Council on Nutrition Appetite Questionnaire
Description
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.
Time Frame
6 weeks
Title
Changes of the Dietary Well-Being Scale
Description
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.
Time Frame
6 weeks
Title
Changes of the Swallowing Quality of Life questionnaire
Description
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.
Time Frame
6 weeks
Title
Changes of the WHO Quality of Life-BREF
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
En-Chi Chiu, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
National Taipei University of Nursing and Health Sciences
City
Taipei City
State/Province
Beitou Dist
ZIP/Postal Code
12303
Country
Taiwan

12. IPD Sharing Statement

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

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