NCT04347863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

April 13, 2020

Last Update Submit

April 13, 2020

Conditions

StrokeDysphagia, Late Effect of Stroke

Keywords

Food preparationDietary well-beingQuality of lifeDysphagiaStroke

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Group swallowing disorder diet preparation program

Other: Group swallowing disorder diet preparation program

Control group

NO INTERVENTION

No Intervention

Interventions

Group swallowing disorder diet preparation programOTHER

This program included food properties, select food, type of cooking, using thickener and tasting

Experimental group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis is stroke
  • EAT-10 ≥ 3
  • Aged \> 20 years
  • Capability of following instructions
  • Willing to participants to the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, Beitou Dist, 12303, Taiwan

Location

MeSH Terms

Conditions

StrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • En-Chi Chiu, PhD

    National Taipei University of Nursing and Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 15, 2020

Study Start

April 19, 2018

Primary Completion

September 28, 2018

Study Completion

September 28, 2018

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

TW(1)