Ischemic StrokeNCT02140658
Affect of Health Education on Statins Medication Persistence and ClinicaL Prognosis of Ischemic Stroke Patients (HELP)
A study testing multiple health education interventions and conventional health education in people with Ischemic Stroke, run by yongjun wang at 1 site in China.
Trial summary
The purpose of this study is to assess the affect of multiple health education interventions for statins medication Persistence and clinical prognosis of ischemic stroke patients at 3, 6 and 12 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- multiple health education interventions and conventional health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,111 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Sep 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (male or female ≥18 years);
- Acute ischemic stroke occured within 14 days of symptoms onset
- Blood low density lipoprotein (LDL) ≧100mg/dl（2.59mmol/L）
- Patients were prescribed statins at discharge
- Patients signed informed consent
- Patients have a cell phone and have the ability to receive and view messages
Who cannot join
- Non-cerebrovascular events or hemorrhagic stroke
- Patients have serious heart, liver, kidney dysfunction or coagulation disorders
- Patients have circumstances that may affect the follow-up such as disturbance of consciousness, severe depression or other mental disorders, aphasia
- Modified Rankin Scale score at discharge ≥3
- Patients with severe vision or vision field impairment which may affect patients to read message in cell phone
- Those who are participating in other clinical trials
- Those who can not guarantee with the completion of 6 month follow-up after enrollment
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tian Tan Hospital, Capital Medical University
Beijing, 100050
About this study
Official title: Affect of Multiple Health Education Interventions on Statins Medication Persistence and ClinicaL Prognosis of Ischemic Stroke Patients (HELP): a Prospective Cohort Study
The purpose of this study is to assess the affect of multiple health education interventions for statins medication Persistence and clinical prognosis of ischemic stroke patients at 3, 6 and 12 months.
Read the detailed description
The study is a prospective, multicenter, hospital-based study on secondary prevention for patients with ischemic cerebrovascular diseases between May 2014 and June 2015. Physicians from 24 hospitals in Beijing underwent a standard secondary prevention training of ischemic cerebrovascular diseases by professional training, instruction manuals, stratification management software. In order to improve the persistence of taking preventive secondary medicine, IS patients from these 24 hospitals received healthy education through manuals and Digital Video Disc about health education during hospitalization and acquired secondary preventive knowledge of ischemic cerebrovascular diseases through regular health education messages during 6 months after discharge. Patients with IS from other 6 hospitals were used as a control, and no such intervention was given to them.
Telephone follow-up was performed at 3 months, 6 months, and 1 year after the onset of cerebral infarction, during which the use of antiplatelet and statins drugs and recurrence of IS were recorded. Patients who took antiplatelet drugs or statins at three follow-ups were regarded as persistent antiplatelet drugs or statins taking within one year after the onset of the disease. The main prognostic indicator was the recurrence of IS and persistence of statins medication within 1 year, and the main purpose was to explore the impact of persistent statins use on IS recurrence.
- Conditions
- Ischemic Stroke
- Being tested
- multiple health education interventions, conventional health education
- Keywords
- ischemic stroke, Statins Medication Persistence, outcome
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple health education interventionsBehavioural
conventional health educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| multiple health education interventions | Active comparator | The first group will receive health education manuals and Digital Video Disc (DVD) during hospitalization and regular health education messages during 6 months after discharge. Receives: Behavioral: multiple health education interventions |
| conventional health education | Placebo comparator | The second group will receive conventional health education during hospitalization except health education manuals, regular health education messages and Digital Video Disc (DVD) Receives: Behavioral: conventional health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who continued taking statins drugs at three months after stroke onset.
Statins Medication persistence at 3 months. Patients who took statins at three months follow-up were regarded as persistent during three months.
Measured: 3 months after stroke onset
Proportion of patients who continued taking statins drugs at six months after stroke onset.
Statins Medication persistence at 6 months.Patients who took statins at six months follow-up were regarded as persistent at six months.
Measured: 6 months after stroke onset
Proportion of patients who continued taking statins drugs at 12 months after stroke onset.
Statins Medication persistence at 12 months.Patients who took statins at twelve months follow-up were regarded as persistent at twelve months.
Measured: 12 months after stroke onset
Proportion of patients who continued taking statins drugs in 1 year after stroke onset.
Statins Medication persistence in 1 year: Patients who took statins at 3, 6 and 12 months follow-up were regarded as persistent during one year after stroke onset.
Measured: 1 year after stroke onset
Recurrence of ischemic stroke in three months after stroke onset
Recurrence of ischemic stroke was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
Measured: 3 months after stroke onset
Recurrence of ischemic stroke in six months after stroke onset
Recurrence of ischemic stroke was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
Measured: 6 months after stroke onset
Recurrence of ischemic stroke in 12 months after stroke onset
Recurrence of ischemic stroke was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
Measured: 12 months after stroke onset
Secondary outcomes (3)
Percentage of patients with 3-month poor clinical prognosis (including Death or Nonfatal myocardial infarction or Nonfatal hemorrhagic stroke or Severe disabilities) as a cluster and evaluated individually
Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4
Measured: 3 months after stroke onset
Percentage of patients with 6-month poor clinical prognosis (including Death or Nonfatal myocardial infarction or Nonfatal hemorrhagic stroke or Severe disabilities) as a cluster and evaluated individually
Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4
Measured: 6 months after stroke onset
Percentage of patients with 12-month poor clinical prognosis (including Death or Nonfatal myocardial infarction or Nonfatal hemorrhagic stroke or Severe disabilities) as a cluster and evaluated individually
Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4
Measured: 12 months after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- yongjun wang
- Sponsor type
- Other government
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Sponsor-investigator, yongjun wang, Ministry of Science and Technology of the People´s Republic of China
- Investigators
- Yongjun Wang, MD, Principal investigator, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140658
- Sponsor's protocol ID
- TTYY20140312
- Status last verified
- Dec 2018
- First submitted
- 5 May 2014
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affect of Multiple Health Education Interventions on Statins Medication Persistence and ClinicaL Prognosis of Ischemic Stroke Patients (HELP): a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02140658
- Acronym / sponsor ID
- TTYY20140312
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, Statins Medication Persistence, outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,111 participants (actual)
- Lead sponsor
- yongjun wangOther government
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- May 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 May 2014 (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 assess the affect of multiple health education interventions for statins medication Persistence and clinical prognosis of ischemic stroke patients at 3, 6 and 12 months.
Detailed description
The study is a prospective, multicenter, hospital-based study on secondary prevention for patients with ischemic cerebrovascular diseases between May 2014 and June 2015. Physicians from 24 hospitals in Beijing underwent a standard secondary prevention training of ischemic cerebrovascular diseases by professional training, instruction manuals, stratification management software. In order to improve the persistence of taking preventive secondary medicine, IS patients from these 24 hospitals received healthy education through manuals and Digital Video Disc about health education during hospitalization and acquired secondary preventive knowledge of ischemic cerebrovascular diseases through regular health education messages during 6 months after discharge. Patients with IS from other 6 hospitals were used as a control, and no such intervention was given to them.
Telephone follow-up was performed at 3 months, 6 months, and 1 year after the onset of cerebral infarction, during which the use of antiplatelet and statins drugs and recurrence of IS were recorded. Patients who took antiplatelet drugs or statins at three follow-ups were regarded as persistent antiplatelet drugs or statins taking within one year after the onset of the disease. The main prognostic indicator was the recurrence of IS and persistence of statins medication within 1 year, and the main purpose was to explore the impact of persistent statins use on IS recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiple health education interventions | Active comparator | Behavioral: multiple health education interventionsThe first group will receive health education manuals and Digital Video Disc (DVD) during hospitalization and regular health education messages during 6 months after discharge. |
| conventional health education | Placebo comparator | Behavioral: conventional health educationThe second group will receive conventional health education during hospitalization except health education manuals, regular health education messages and Digital Video Disc (DVD) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult subjects (male or female ≥18 years);
- Acute ischemic stroke occured within 14 days of symptoms onset
- Blood low density lipoprotein (LDL) ≧100mg/dl（2.59mmol/L）
- Patients were prescribed statins at discharge
- Patients signed informed consent
Key exclusion criteria (7 listed)
- Non-cerebrovascular events or hemorrhagic stroke
- Patients have serious heart, liver, kidney dysfunction or coagulation disorders
- Patients have circumstances that may affect the follow-up such as disturbance of consciousness, severe depression or other mental disorders, aphasia
- Modified Rankin Scale score at discharge ≥3
- Patients with severe vision or vision field impairment which may affect patients to read message in cell phone
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 |
|---|---|---|
| multiple health education interventions | Behavioural | multiple health education interventions |
| conventional health education | Behavioural | conventional health education |
Primary outcome
Proportion of patients who continued taking statins drugs at three months after stroke onset.
Time frame: 3 months after stroke onset
Statins Medication persistence at 3 months. Patients who took statins at three months follow-up were regarded as persistent during three months.
Proportion of patients who continued taking statins drugs at six months after stroke onset.
Time frame: 6 months after stroke onset
Statins Medication persistence at 6 months.Patients who took statins at six months follow-up were regarded as persistent at six months.
Proportion of patients who continued taking statins drugs at 12 months after stroke onset.
Time frame: 12 months after stroke onset
Statins Medication persistence at 12 months.Patients who took statins at twelve months follow-up were regarded as persistent at twelve months.
Proportion of patients who continued taking statins drugs in 1 year after stroke onset.
Time frame: 1 year after stroke onset
Statins Medication persistence in 1 year: Patients who took statins at 3, 6 and 12 months follow-up were regarded as persistent during one year after stroke onset.
Recurrence of ischemic stroke in three months after stroke onset
Time frame: 3 months after stroke onset
Recurrence of ischemic stroke was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
Recurrence of ischemic stroke in six months after stroke onset
Time frame: 6 months after stroke onset
Recurrence of ischemic stroke was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
Recurrence of ischemic stroke in 12 months after stroke onset
Time frame: 12 months after stroke onset
Recurrence of ischemic stroke was defined as a new focal neurological deficit of vascular origin lasting >24 hours and without hemorrhage on computed tomography or MRI of the brain.
3 secondary outcomes
Percentage of patients with 3-month poor clinical prognosis (including Death or Nonfatal myocardial infarction or Nonfatal hemorrhagic stroke or Severe disabilities) as a cluster and evaluated individually
Time frame: 3 months after stroke onset
Percentage of patients with 6-month poor clinical prognosis (including Death or Nonfatal myocardial infarction or Nonfatal hemorrhagic stroke or Severe disabilities) as a cluster and evaluated individually
Time frame: 6 months after stroke onset
Percentage of patients with 12-month poor clinical prognosis (including Death or Nonfatal myocardial infarction or Nonfatal hemorrhagic stroke or Severe disabilities) as a cluster and evaluated individually
Time frame: 12 months after stroke onset
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 11 Dec 2018.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
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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.
Yongjun Wang, MD principal investigator
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multiple health education interventions and conventional health education in people with Ischemic Stroke, run by yongjun wang 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 6 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 11 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
Proportion of patients who continued taking statins drugs at three months after stroke onset. (time frame: 3 months after stroke onset). 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?
On the ClinicalTrials.gov record for NCT02140658, which also lists 1 linked publication.
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 11 Dec 2018.