Affect of Multiple Health Education on Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients

NCT02140619 | Completed DMC

• 1 other identifier: TTYY-20131201
• Study Type: interventional
• Target: 3,111
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to demonstrate the relationship between secondary prevention medication persistence and clinical prognosis of ischemic stroke patients at 3,6,12 months

Conditions

Ischemic Stroke; Medication Persistence

Keywords

ischemic stroke; Medication Persistence; outcome

Outcome Measures

Primary Outcomes (7)

• Proportion of patients who continued taking antiplatelet drugs at three months after stroke onset, and proportion of patients who continued taking statins drugs at three months after stroke onset.

  Medication persistence at 3 months. Persistence is defined as continuing a therapy or class of therapy from discharge to the 3 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.

  3 months after stroke onset

• Proportion of patients who continued taking antiplatelet drugs at six months after stroke onset, and proportion of patients who continued taking statins drugs at six months after stroke onset.

  Medication persistence at 6 months. Persistence at 6 months is defined as continuing a therapy or class of therapy at 6 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.

  6 months after stroke onset

• Proportion of patients who continued taking antiplatelet drugs at 12 months after stroke onset, and proportion of patients who continued taking statins drugs at 12 months after stroke onset.

  Medication persistence at 12 months. Persistence at 12 months is defined as continuing a therapy or class of therapy at 12 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.

  12 months after stroke onset

• Proportion of patients who continued taking antiplatelet drugs in 1 year after stroke onset, and proportion of patients who continued taking statins drugs in 1 year after stroke onset.

  Patients who took statins and antiplatelet medications at 3, 6 and 12 months follow-up were regarded as persistent during one year after stroke onset.

  1 year after stroke onset

• Recurrence of ischemic stroke in three months after stroke onset

  Recurrence of IS 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 months after stroke onset

• Recurrence of ischemic stroke in six months after stroke onset

  Recurrence of IS 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.

  6 months after stroke onset

• Recurrence of ischemic stroke in 12 months after stroke onset

  Recurrence of IS 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.

  12 months after stroke onset

Secondary Outcomes (1)

• clinical prognosis

  3,6,12 months

Study Arms (2)

multiple health education interventions

ACTIVE COMPARATOR

The group will receive health education manuals and Digital Video Disc (DVD) during hospitalization and regular text message during 1 year after discharge.

Behavioral: multiple health education interventions

conventional health education

PLACEBO COMPARATOR

The second group will receive conventional health education during hospitalization except health education manuals, text message and Digital Video Disc (DVD)

Behavioral: multiple health education interventions

Interventions

multiple health education interventions BEHAVIORAL

conventional health education; multiple health education interventions

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (male or female ≥18 years);
• Acute ischemic stroke occured within 14 days of symptoms onset
• Patients signed informed consent
• Patients have a cell phone and have the ability to receive and view messages

You may not qualify if:

• 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
• Those who are participating in other clinical trials
• Those who can not guarantee with the completion of 1 year follow-up after enrollment

Sponsors & Collaborators

• yongjun wang: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

• 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.

  PMID: 34813082 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Medication Adherence

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• yongjun wang, MD

  Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor,Vice president of Beijing Tiantan Hospital

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 16, 2014
• Study Start: May 1, 2014
• Primary Completion: June 28, 2015
• Study Completion: September 30, 2015
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

CN (1)