UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007808 |
|---|---|
| Receipt number | R000009198 |
| Scientific Title | Construction of a disease management program and evidences for preventing recurrence of stroke in community settings |
| Date of disclosure of the study information | 2012/04/22 |
| Last modified on | 2019/07/09 21:38:04 |
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Basic information
Public title
Construction of a disease management program and evidences for preventing recurrence of stroke in community settings
Acronym
DMP stroke trial
Scientific Title
Construction of a disease management program and evidences for preventing recurrence of stroke in community settings
Scientific Title:Acronym
DMP stroke trial
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to develop a post stroke disease-management patient education program and the system, apply it to the patients, and verify the efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Framingham Risk Score: general cardiovascular disease 10 year risk
Key secondary outcomes
Cumulative incidence rate of stroke recurrence and the complication (cardiovascular disease)
All-cause mortality
Physiological indicators (Blood pressure, HbA1c, etc)
Psychological indicators (self-efficacy, depression, QOL)
Attainment rate of behavior modification
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Disease management: Including lLong-term patient education by trained nurses(Interviews and telephones for 6 months)
Interventions/Control_2
Usual instruction at clinics
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants carried out on light stroke patients after having been discharged from acute care hospitals.
The diagnoses of hospitalization are cerebral infarction (atherothrombotic, cardioembolic, lacunar, others) and Transient cerebral Ischemic Attack(TIA).
The disease severity in recruit is people from 0 to 3 in Japanese version modified Rankin Scale(mRS).
Key exclusion criteria
A patient (in modified Rankin Scale at the time of recruitment at levels of 4 or 5, 6) having severe complications and the physical symptom that the contents of the program cannot carry out.
A patient (lower than Hasegawa-style intelligence evaluation scale (HDS-R) 20/30 mark) of the dementia.
The patient who is undergoing medical treatment in rehabilitation wards, a medical treatment type wards and long-term care insurance facility.
The terminal stage and a pregnant patient.
Patients whose chief physicians judge that the enforcement of the program causes problems on the patients.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | MORIYAMA |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Division of Nursing Science
Zip code
734-8553
Address
Kasumi 1-2-3 Minami-ku, Hiroshima, 734-8553 Japan
TEL
082-257-5365
morimich@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | FUKUOKA |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Division of Nursing Science
Zip code
734-8553
Address
Kasumi 1-2-3 Minami-ku, Hiroshima, 734-8553 Japan
TEL
082-257-5367
Homepage URL
yasukofukuoka@hotmail.com
Sponsor or person
Institute
Hiroshima University, Institute of Biomedical & Health Sciences
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University hospital IRB
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan
Tel
082-257-5596
hugcp@hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.strokejournal.org/article/S1052-3057(14)00506-0/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.ahajournals.org/doi/10.1161/STROKEAHA.118.020888
Number of participants that the trial has enrolled
321
Results
Regarding the primary end point, there was no significant difference in the changes in the Framingham risk score at any follow-up time between the groups. The incidence of stroke recurrence tended to be lower in the disease management program intervention group, although no significant difference was found (hazard ratio, 0.49; 95% CI, 0.19-1.29).
Results date posted
| 2019 | Year | 06 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients aged between 40 and 80 years who experienced their last ischemic stroke event or transient ischemic attack within 1 year.
Participant flow
Of the 562 subjects who met the criteria, 321 consented to participate in the study (consent rate 57.1%; Figure 1). The subjects were randomly assigned to the DMP intervention group (n=156) or the usual care group (n=165). The final follow-up rates were 78.8% in the DMP intervention group and 76.4% in the usual care group.
Adverse events
nothing
Outcome measures
The primary end point of this study was the difference in the Framingham risk score (general cardiovascular disease 10-year risk) from baseline. The secondary end points of this study included stroke recurrence, onset of cardiovascular disease, all-cause mortality, and all vascular events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 02 | Month | 16 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 22 | Day |
Last modified on
| 2019 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009198
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