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

Disease Management Program (DMP) Stroke Trial

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Other: usual care; Other: disease management

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Hiroshima
    • Hiroshima city, Hiroshima, Japan, 734-8553
      • Hiroshima University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: usual care; usual care group receive regular outpatient treatment	Other: usual care; usual care group receive regular outpatient treatment
Experimental: disease management; desease management program include self management education by nurse on 6months.	Other: usual care; usual care group receive regular outpatient treatment; Other: disease management; disease management program include self management education; Other Names: Intervention of disease management program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hiroshima University
• Collaborators: Ministry of Health, Labour and Welfare, Japan
• Investigators: Principal Investigator: Michiko Moriyama, RN, PhD., Hiroshima University

Publications and helpful links

General 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.
• Fukuoka Y, Hosomi N, Hyakuta T, Omori T, Ito Y, Uemura J, Yagita Y, Kimura K, Matsumoto M, Moriyama M; for DMP Stroke Trial Investigators. Effects of a Disease Management Program for Preventing Recurrent Ischemic Stroke. Stroke. 2019 Mar;50(3):705-712. doi: 10.1161/STROKEAHA.118.020888.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: stroke, disease management programs, self-management
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: 21171401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided