Cardiovascular DiseasesNCT01426282
The Effects of Health Education in Cardiovascular Diseases Prevention and Treatment
A study testing health education in people with Cardiovascular Diseases, run by Lihua Xu at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effects of health education given by nurse on out-patient compliance in cardiovascular diseases prevention and treatment. Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- Feb 2009to Jun 2010
- 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 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first diagnosis cardiovascular disease
Who cannot join
- Severe liver and kidney disease or cancer
- Limb movement disorder
- Cognitive impairment
- History of malignant arrhythmia or severe heart failure patients have a high risk of sudden death
- Diabetes
- Cerebrovascular disease
- History of atherosclerotic disease hospital
Trial locations and contacts
1 site in 1 country.
China1 site
the first college of Harbin Medical University
Harbin, Heilongjiang, 150001
About this study
Official title: The Effects of Health Education Given by Nurse on Out-patient Compliance in Cardiovascular Diseases Prevention and Treatment in China
The purpose of this study is to evaluate the effects of health education given by nurse on out-patient compliance in cardiovascular diseases prevention and treatment.
- Conditions
- Cardiovascular Diseases
- Being tested
- no intervention, health education
- Keywords
- Out-patient Compliance, Nurse, Heath Education, Cardiovascular Diseases, Treatment and Prevention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
health educationOther
Also called health education given by nurse
15 minutes health education given by nurse according to " The Chinese Resident Meals Guide " , "National Revision Committee of the Guidelines of Hypertension Prevention and Control in 2005" , " Guidelines on Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults " , " Guideline for diagnosis and treatment of patients with chronic stable angina "," Guideline for prevention and treatment overweight and obesity in chinese adults "
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described Receives: Other: no intervention |
| nurse education | Experimental | Not described Receives: Other: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
SBP and DBP
Measured: 1 year
lipid
TC,LDL,TG
Measured: 1 year
Adherence drug administration
Adherence drug administration in one month and in one year
Measured: 1 year
Hospitalization
hospitalization due to cardiovascular and cerebrovascular disease
Measured: 1 year
Secondary outcomes (3)
Exercise time(hours/week)
Measured: 1 year
smoking
Number of smoker and Amount of smoke per day
Measured: 1 year
body weight
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lihua Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lihua Xu, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426282
- Sponsor's protocol ID
- JHH 001
- Status last verified
- Aug 2011
- First submitted
- 2 Aug 2011
- Last updated
- 31 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Health Education Given by Nurse on Out-patient Compliance in Cardiovascular Diseases Prevention and Treatment in China
- ClinicalTrials.gov ID
- NCT01426282
- Acronym / sponsor ID
- JHH 001
- Conditions
- Cardiovascular Diseases
- Keywords
- Out-patient Compliance, Nurse, Heath Education, Cardiovascular Diseases, Treatment and Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Lihua XuUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 31 Aug 2011 (estimated)
- 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.
The purpose of this study is to evaluate the effects of health education given by nurse on out-patient compliance in cardiovascular diseases prevention and treatment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | Other: no intervention |
| nurse education | Experimental | Other: health education |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- first diagnosis cardiovascular disease
Key exclusion criteria (7 listed)
- Severe liver and kidney disease or cancer
- Limb movement disorder
- Cognitive impairment
- History of malignant arrhythmia or severe heart failure patients have a high risk of sudden death
- Diabetes
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 |
|---|---|---|
| no interventionno intervention | Other | control |
| health educationAlso: health education given by nurse15 minutes health education given by nurse according to " The Chinese Resident Meals Guide " , "National Revision Committee of the Guidelines of Hypertension Prevention and Control in 2005" , " Guidelines on Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults " , " Guideline for diagnosis and treatment of patients with chronic stable angina "," Guideline for prevention and treatment overweight and obesity in chinese adults " | Other | nurse education |
Primary outcome
blood pressure
Time frame: 1 year
SBP and DBP
lipid
Time frame: 1 year
TC,LDL,TG
Adherence drug administration
Time frame: 1 year
Adherence drug administration in one month and in one year
Hospitalization
Time frame: 1 year
hospitalization due to cardiovascular and cerebrovascular disease
3 secondary outcomes
Exercise time(hours/week)
Time frame: 1 year
smoking
Time frame: 1 year
body weight
Time frame: 1 year
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 31 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education in people with Cardiovascular Diseases, run by Lihua Xu 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 7 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 31 Aug 2011. 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?
blood pressure (time frame: 1 year). The study lists 4 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 31 Aug 2011.