The Effects of Disease Management Programs for Prevention of Recurrent Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

Disease Management Program (DMP) Stroke Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121327
• Other study ID #: 21171401
• Status: Completed
• Phase: N/A
• First received: January 15, 2014
• Last updated: February 21, 2018
• Start date: September 2010
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It has been reported that stroke is the first cause of becoming bedridden, and its cumulative recurrence rate in 5 years is approximately 35%. There is a high probability that patients reduce or discontinue medications by self-determination, leading to a high risk of stroke recurrence in these patients. Comprehensive and long-term patient educations ameliorating their self-management are important making patients possible to be managed according to the guidelines for their risk factors. Using disease management programs created for each of risk factors according to clinical practice guidelines, the influence of those programs were evaluated for the prevention of stroke recurrence in this Disease Management Program Stroke Trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Ischemic stroke onset [including transient ischemic attack (TIA)].

• Receiving regular consultation with their primary care physician.

• modified Rankin Scale (mRS) score from 0 to 3 at discharge.

Exclusion Criteria:

• modified Rankin Scale (mRS) score 4 and over at discharge .

• Patient having severe complications and the physical symptom that the contents of the program cannot carry out.

• They had medical care in medical/nursing care institutions.

• Patients with pregnancy or under terminal care.

• Dementia (scores of =20/30 on the Revised Hasegawa's Dementia Scale) However, when a care-giving family member living with the patient could provide self-management, patients were included even if they had dementia.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• disease management
disease management program include self management education
• usual care
usual care group receive regular outpatient treatment

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima city	Hiroshima

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Framingham Risk Score: general cardiovascular disease 10 year risk	Use score of Framingham Risk Score: general cardiovascular disease 10 year risk	2.5 years
Secondary	Cumulative incidence rate of stroke recurrence and the complication (cardiovascular disease)	Questionnaire to a patient, and checking it by a nurse	2.5 years
Secondary	All-cause mortality	Questionnaire to a patient, and checking it by a nurse	2.5 years
Secondary	body weight	Questionnaire to a patient	2.5 years
Secondary	body mass index	Calculation of height and the weight of the patient	2.5 years
Secondary	blood pressure	Questionnaire to a patient	2.5 years
Secondary	cholesterol	total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride The patient mails the copy of the blood test result	2.5 years
Secondary	serum creatinine	The patient mails the copy of the blood test result	2.5 years
Secondary	blood urea nitrogen	The patient mails the copy of the blood test result	2.5 years
Secondary	glycated hemoglobin (HbA1c)	The patient mails the copy of the blood test result	2.5 years
Secondary	blood glucose	The patient mails the copy of the blood test result	2.5 years
Secondary	prothronbin time international rate	only as for the necessary paticipant The patient mails the copy of the blood test result	2.5 years
Secondary	Mental Depression degree	Using score of The Center for Epidemiologic Depression Scale (CES-D)	2.5 years
Secondary	self-efficacy degree	Using score of self-efficacy scale on health behavior in patient with chronic disease	2.5 years
Secondary	Qiality of Life (QOL) degree	Using score of MOS 36-item short form (SF-36)	2.5 years
Secondary	Evaluated subject frequency of checking blood pressure	Questionnaire to a patient	2.5 years
Secondary	Evaluated subject frequency of taking medicine	Questionnaire to a patient	2.5 years
Secondary	Evaluated subject frequency of keeping the prescribed diet	Questionnaire to a patient	2.5 years
Secondary	Evaluated subject frequency of exercising	Questionnaire to a patient	2.5 years