Parkinson DiseaseNCT04934592
Correlation Between Non-motor Symptoms and Malnutrition in Patients With Parkinson's Disease
An observational study of Parkinson Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study used Mini Nutrition Assessment (MNA) , Nutrition risk screening 2002(NRS-2002) and Non-motor Symptom Quest (NMSquest) to investigate the nutritional status of patients with Parkinson's disease, to analyze the correlation between non-motor symptoms and malnutrition in patients with Parkinson's disease (PD) … Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2020to 30 Nov 2021
- How long will I take part?
- 2 Weeks
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson in the hospital
Who may be able to join
- Length of stay > 24 hours; Parkinson patients who met Chinese diagnostic criteria for Parkinson's disease (2016 edition) ; willing to participate in the study and able to complete the scale.
Who cannot join
- Parkinson's disease caused by cerebrovascular disease, Encephalitis, traumatic brain injury; patients who have received whole blood, plasma, albumin within one month; patients with severe gastrointestinal disease, metabolic disease and other wasting diseases; Patients with critical illness, severe cognitive impairment, and inability to communicate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang
QiaoMin Tang, 13957108417, julia4711@126.com
About this study
This study used Mini Nutrition Assessment (MNA) , Nutrition risk screening 2002(NRS-2002) and Non-motor Symptom Quest (NMSquest) to investigate the nutritional status of patients with Parkinson's disease, to analyze the correlation between non-motor symptoms and malnutrition in patients with Parkinson's disease (PD) , and to provide evidence for clinical treatment and early nutritional intervention.
Read the detailed description
Data were collected by questionnaire survey.For arkinson patients who were admitted to the facility between June 2020 and July 2021 were targeted. This study used convenience sampling and included criteria: length of stay > 24 hours; Parkinson patients who met Chinese diagnostic criteria for Parkinson's disease (2016 edition) ; willing participants and able to complete the scale. Exclusion criteria: parkinsonism caused by cerebrovascular disease, encephalitis, traumatic brain injury, complete transfusion of blood, plasma, albumin within one month, severe gastrointestinal disease, metabolic disease, and other wasting diseases; Patients with critical illness, severe cognitive impairment, and inability to communicate. The study was approved by the medical ethics committee with the informed consent of all selected individuals and their families
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of nutritional risk Nutrition Assessment
Mini Nutritional Assessment (MNA) score. This scale is used to evaluate the nutritional status .MNA consists of 18 subjects, covering four aspects: anthropometric assessment, general state assessment, recent diet assessment and subjective self-assessment. The total score is 30. Malnutrition is defined as score < 17, critical state of malnutrition is defined as score 17-24, and good nutrition is defined as score > 24.
Measured: Within 8 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start30 Jun 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 85 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934592
- Sponsor's protocol ID
- 2020-376
- Status last verified
- May 2021
- First submitted
- 28 May 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Non-motor Symptoms and Malnutrition in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04934592
- Acronym / sponsor ID
- 2020-376
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 22 Jun 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.
This study used Mini Nutrition Assessment (MNA) , Nutrition risk screening 2002(NRS-2002) and Non-motor Symptom Quest (NMSquest) to investigate the nutritional status of patients with Parkinson's disease, to analyze the correlation between non-motor symptoms and malnutrition in patients with Parkinson's disease (PD) , and to provide evidence for clinical treatment and early nutritional intervention.
Detailed description
Data were collected by questionnaire survey.For arkinson patients who were admitted to the facility between June 2020 and July 2021 were targeted. This study used convenience sampling and included criteria: length of stay > 24 hours; Parkinson patients who met Chinese diagnostic criteria for Parkinson's disease (2016 edition) ; willing participants and able to complete the scale. Exclusion criteria: parkinsonism caused by cerebrovascular disease, encephalitis, traumatic brain injury, complete transfusion of blood, plasma, albumin within one month, severe gastrointestinal disease, metabolic disease, and other wasting diseases; Patients with critical illness, severe cognitive impairment, and inability to communicate. The study was approved by the medical ethics committee with the informed consent of all selected individuals and their families
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson in the hospital
Key inclusion criteria (1 listed)
- Length of stay > 24 hours; Parkinson patients who met Chinese diagnostic criteria for Parkinson's disease (2016 edition) ; willing to participate in the study and able to complete the scale.
Key exclusion criteria (1 listed)
- Parkinson's disease caused by cerebrovascular disease, Encephalitis, traumatic brain injury; patients who have received whole blood, plasma, albumin within one month; patients with severe gastrointestinal disease, metabolic disease and other wasting diseases; Patients with critical illness, severe cognitive impairment, and inability to communicate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence rate of nutritional risk Nutrition Assessment
Time frame: Within 8 hours after admission
Mini Nutritional Assessment (MNA) score. This scale is used to evaluate the nutritional status .MNA consists of 18 subjects, covering four aspects: anthropometric assessment, general state assessment, recent diet assessment and subjective self-assessment. The total score is 30. Malnutrition is defined as score < 17, critical state of malnutrition is defined as score 17-24, and good nutrition is defined as score > 24.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
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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.
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 Parkinson Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiaomin Tang (13957108417, julia4711@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of nutritional risk Nutrition Assessment (time frame: Within 8 hours after admission). 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 22 Jun 2021.