StrokeNCT04956471
Guideline - Based Nursing Plan for Dysphagia After Stroke
An observational study of Stroke, run by Peking University Third Hospital at 1 site in China.
Trial summary
Research purposes:1, investigate the nursing management is the head nurse for swallowing disorder after stroke care management status; Compared with the existing research, the difference between guidelines and evidence-based nursing plan and the analysis of the influencing factors.2, the investigation nursing… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- interview
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 1 May 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 15 cases.
Who may be able to join
- Cerebral apoplexy diagnosed by CT or MRI;
- Drinking water from depression > grade 3;
- Be clear and able to communicate;
- Volunteer for the study.
Who cannot join
- If you have serious basic diseases such as cardiovascular and cerebrovascular diseases, you cannot cooperate with the examination.
- The patient refused to accept the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guideline - Based Nursing Plan for Dysphagia After Stroke: Current Status and Influencing Factors
Research purposes:1, investigate the nursing management is the head nurse for swallowing disorder after stroke care management status; Compared with the existing research, the difference between guidelines and evidence-based nursing plan and the analysis of the influencing factors.2, the investigation nursing personnel for swallowing disorder after stroke nursing implementation status; Compare the difference between its and department management requirements and to analyze its influencing factors.3 patients with swallowing disorder after stroke or their caregivers for swallowing disorder after stroke care needs of semi-structured interviews.
Read the detailed description
Research purposes:1, investigate the nursing management is the head nurse for swallowing disorder after stroke care management status; Compared with the existing research, the difference between guidelines and evidence-based nursing plan and the analysis of the influencing factors.2, the investigation nursing personnel for swallowing disorder after stroke nursing implementation status; Compare the difference between its and department management requirements and to analyze its influencing factors.3 patients with swallowing disorder after stroke or their caregivers for swallowing disorder after stroke care needs of semi-structured interviews.Study design.This subject adopts the mixed methods research design, the three parts to complete. Research focuses on the 3 armour hospital for ten. The first part first USES the literature analysis method, systematic review of swallowing disorder after stroke related guidelines and research. According to the guidelines and involved in the study of swallowing disorder after stroke care issues related to design the head nurse questionnaire, then cross-sectional investigation understand swallowing disorder after stroke clinical nursing management present situation in our country. According to the regional distribution plans to choose 10 3 armour hospital survey, about 15 head nurse.The second part first USES the literature analysis method, systematic review of swallowing disorder after stroke related guidelines and research. According to the guidelines and involved in the study of brain 4 cross-sectional survey) 108%Understanding of the brain in our country。Hospital survey,About 250 nurses. The third part USES the qualitative research in the design of phenomenological research methods, through face-to-face semi-structured interviews, collect data, understand the needs of patients and their caregivers, guide the nursing measures of existing. Selection of founding of neurology ward patients as the research and interview object, about 20 cases need to sample.
- Conditions
- Stroke
- Being tested
- interview
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
A sample method: convenience sampling, selecting A 3 armour hospital between September 2019 and January 2020 neurology hospital patients with swallowing disorder after stroke, about 15 cases.
| Study group | Role | What they receive |
|---|---|---|
| hospitalized patients with swallowing disorder after stroke,. | Not described Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 swallowing disorder after stroke care management present situation investigation
The first part of swallowing disorder after stroke care management present situation investigation; Investigation includes general information and management status. A data includes gender, age, working years, job position, cultural degree, whether to have participated in related training. Current conditions including room management specification, nurse training, swallowing dysfunction screening and evaluation management, nutrition, management of complications.
Measured: One year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Jul 2019
- Primary completion1 May 2020
- Study completion1 May 2021
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baohua Li, Study chair, Peking Yniversity Third Hospital Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956471
- Sponsor's protocol ID
- M2019312
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guideline - Based Nursing Plan for Dysphagia After Stroke: Current Status and Influencing Factors
- ClinicalTrials.gov ID
- NCT04956471
- Acronym / sponsor ID
- M2019312
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 9 Jul 2021 (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.
Research purposes:1, investigate the nursing management is the head nurse for swallowing disorder after stroke care management status; Compared with the existing research, the difference between guidelines and evidence-based nursing plan and the analysis of the influencing factors.2, the investigation nursing personnel for swallowing disorder after stroke nursing implementation status; Compare the difference between its and department management requirements and to analyze its influencing factors.3 patients with swallowing disorder after stroke or their caregivers for swallowing disorder after stroke care needs of semi-structured interviews.
Detailed description
Research purposes:1, investigate the nursing management is the head nurse for swallowing disorder after stroke care management status; Compared with the existing research, the difference between guidelines and evidence-based nursing plan and the analysis of the influencing factors.2, the investigation nursing personnel for swallowing disorder after stroke nursing implementation status; Compare the difference between its and department management requirements and to analyze its influencing factors.3 patients with swallowing disorder after stroke or their caregivers for swallowing disorder after stroke care needs of semi-structured interviews.Study design.This subject adopts the mixed methods research design, the three parts to complete. Research focuses on the 3 armour hospital for ten. The first part first USES the literature analysis method, systematic review of swallowing disorder after stroke related guidelines and research. According to the guidelines and involved in the study of swallowing disorder after stroke care issues related to design the head nurse questionnaire, then cross-sectional investigation understand swallowing disorder after stroke clinical nursing management present situation in our country. According to the regional distribution plans to choose 10 3 armour hospital survey, about 15 head nurse.The second part first USES the literature analysis method, systematic review of swallowing disorder after stroke related guidelines and research. According to the guidelines and involved in the study of brain 4 cross-sectional survey) 108%Understanding of the brain in our country。Hospital survey,About 250 nurses. The third part USES the qualitative research in the design of phenomenological research methods, through face-to-face semi-structured interviews, collect data, understand the needs of patients and their caregivers, guide the nursing measures of existing. Selection of founding of neurology ward patients as the research and interview object, about 20 cases need to sample.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hospitalized patients with swallowing disorder after stroke,. | – | Other: interview |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 15 cases.
Key inclusion criteria (4 listed)
- Cerebral apoplexy diagnosed by CT or MRI;
- Drinking water from depression > grade 3;
- Be clear and able to communicate;
- Volunteer for the study.
Key exclusion criteria (2 listed)
- If you have serious basic diseases such as cardiovascular and cerebrovascular diseases, you cannot cooperate with the examination.
- The patient refused to accept the investigator.
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 |
|---|---|---|
| interviewA sample method: convenience sampling, selecting A 3 armour hospital between September 2019 and January 2020 neurology hospital patients with swallowing disorder after stroke, about 15 cases. | Other | hospitalized patients with swallowing disorder after stroke,. |
Primary outcome
1 swallowing disorder after stroke care management present situation investigation
Time frame: One year after recruitment
The first part of swallowing disorder after stroke care management present situation investigation; Investigation includes general information and management status. A data includes gender, age, working years, job position, cultural degree, whether to have participated in related training. Current conditions including room management specification, nurse training, swallowing dysfunction screening and evaluation management, nutrition, management of complications.
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 9 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Baohua Li study chair
Peking Yniversity Third Hospital Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Peking University Third Hospital at 1 site in China.
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 4 inclusion and 2 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 9 Jul 2021. 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 China. 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?
1 swallowing disorder after stroke care management present situation investigation (time frame: One year after recruitment). 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 9 Jul 2021.