StrokeNCT04347863
Investigating Program of Food Preparation on Diet Improvement for Patients With Stroke
A study testing Group swallowing disorder diet preparation program in people with Stroke and Dysphagia, Late Effect of Stroke, run by Taiwan Adventist Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke, Dysphagia, Late Effect of Stroke
- What is being tested?
- Group swallowing disorder diet preparation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Apr 2018to 28 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis is stroke
- EAT-10 ≥ 3
- Aged > 20 years
- Capability of following instructions
- Willing to participants to the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taipei University of Nursing and Health Sciences
Taipei, Beitou Dist, 12303
About this study
This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of food preparation on diet improve patients with stroke.
Read the 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.
- Conditions
- Stroke, Dysphagia, Late Effect of Stroke
- Being tested
- Group swallowing disorder diet preparation program
- Keywords
- Food preparation, Dietary well-being, Quality of life, Dysphagia, Stroke
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group swallowing disorder diet preparation programOther
This program included food properties, select food, type of cooking, using thickener and tasting
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Group swallowing disorder diet preparation program Receives: Other: Group swallowing disorder diet preparation program |
| Control group | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start19 Apr 2018
- Primary completion28 Sep 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Adventist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- En-Chi Chiu, PhD, Study director, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347863
- Sponsor's protocol ID
- 106-E-29
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Program of Food Preparation on Diet Improvement for Patients With Stroke
- ClinicalTrials.gov ID
- NCT04347863
- Acronym / sponsor ID
- 106-E-29
- Conditions
- Stroke, Dysphagia, Late Effect of Stroke
- Keywords
- Food preparation, Dietary well-being, Quality of life, Dysphagia, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Taiwan Adventist HospitalUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Group swallowing disorder diet preparation programGroup swallowing disorder diet preparation program |
| Control group | No intervention | –No Intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis is stroke
- EAT-10 ≥ 3
- Aged > 20 years
- Capability of following instructions
- Willing to participants to the study
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group swallowing disorder diet preparation programThis program included food properties, select food, type of cooking, using thickener and tasting | Other | Experimental group |
Primary outcome
Changes of the Eating Assessment Tool-10
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
En-Chi Chiu, PhD study director
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group swallowing disorder diet preparation program in people with Stroke and Dysphagia, Late Effect of Stroke, run by Taiwan Adventist Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the Eating Assessment Tool-10 (time frame: 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.