UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045178 |
|---|---|
| Receipt number | R000051321 |
| Scientific Title | Evaluation of the nursing intervention model that promotes self-care for schizophrenia patients with lifestyle-related diseases or its risk: multiple case study |
| Date of disclosure of the study information | 2021/09/16 |
| Last modified on | 2023/02/03 15:22:32 |
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Basic information
Public title
Evaluation of the nursing intervention model that promotes self-care for schizophrenia patients with lifestyle-related diseases or its risk: multiple case study
Acronym
Evaluation of Nursing Intervention Model for Schizophrenia Patients with Lifestyle-related Diseases
Scientific Title
Evaluation of the nursing intervention model that promotes self-care for schizophrenia patients with lifestyle-related diseases or its risk: multiple case study
Scientific Title:Acronym
Evaluation of Nursing Intervention Model for Schizophrenia Patients with Lifestyle-related Diseases
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a new nursing model to support self-care for schizophrenia patients who have/are at risk of lifestyle-related diseases or obesity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Do not set primary outcomes.
The following outcomes are evaluated.
(1)validity of this model
(2)feasibility of this model
(3)efficacy of promoting self-care
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A nurse intervenes in patients having schizophrenia for 3 months following the process of the nursing model designed to promote self-care for patients with or at risk of lifestyle-related diseases or obesity
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants are community-based patients having schizophrenia who meet all criteria listed below.
(1) Those who are 20 years old or older and under 75 years old at the time of registration.
(2) Outpatient-based patients who have been diagnosed with schizophrenia, live in the community.
(3) Those whose BMI is 25 or over, or those who have been pointed out that the current physical disease or their risk is due to lifestyle by a doctor.
Including the following diseases, but not limited to; Type 2 diabetes, dyslipidemia (exclude familial hypercholesterolemia), hyperuricemia, hypertension, coronary heart disease, stroke (exclude for dexterity), alcoholic liver disease, Nonalcoholic fatty liver disease, Nonalcoholic steatohepatitis (NASH), obesity-related kidney disease.
(4) Those who have cognitive functions that enable independent activities of daily living and are independent with ADL.
(5) Those who can express own intentions in words, and those who can make a decision on participation in this study.
(6) Those who can sign or write documents in this study.
Key exclusion criteria
(1)Those who have difficulty in daily life due to acute symptoms of schizophrenia and whose safety is not protected due to the symptoms
(2) Those who have hearing or vision impairments and need support in communication.
(3) Those who have death thoughts, risks of suicidal attempts, impulsive behavior, or risky behavior.
(4) Those who have difficulty in making decisions on their participation in this study.
(5) Those who are pregnant
(6) Those who have severe physical complications.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Moriyama |
Organization
Hiroshima University
Division name
Department of Nursing Science, Graduate school of Biomedical and Health sciences
Zip code
734-8553
Address
Kasumi 1-2-3 Minami-Ku,Hiroshima
TEL
082-257-5367
morimich@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Umeki |
Organization
Hiroshima University
Division name
Development of Nursing Science, Graduate school of Biomedical and Health sciences
Zip code
734-8553
Address
Kasumi 1-2-3 Minami-Ku,Hiroshima 734-8553
TEL
082-257-5367
Homepage URL
m204351@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Chronic Care and Family Nursing Lab
Department of Nursing Science
Graduate School of Biomedical and Health Sciences
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima 734-8551
Tel
082-257-1551
iryo-seisaku@office.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
| 2021 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://confit.atlas.jp/guide/event/jans42/subject/P13-10/advanced
Number of participants that the trial has enrolled
2
Results
By intervening the following process of the nursing model designed to promote self-care by the researchers, self-ego of two patients who were participated in the study had been protected and enhanced as we aimed. Their behavior changes related to better lifestyles were observed by mutual works with the research nurse on goal settings of self-care. Based on the results, the original model has been revised.
Results date posted
| 2022 | Year | 03 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Nothing
Date of the first journal publication of results
Baseline Characteristics
A: Male, 40 years old, single, unemployed. BMI 42.3, schizophrenia, history of lifestyle related diseases: metabolic syndrome, stroke
B: Male, 38 years old, single, unemployed, BMI 28.7, schizophrenia, history of lifestyle related diseases: dyslipidemia
Participant flow
Adverse events
Nothing
Outcome measures
(1)Validity of this model
(2)Feasibility of this model
(3)Efficacy of promoting self-care
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051321
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
