UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037255 |
|---|---|
| Receipt number | R000042409 |
| Scientific Title | Development of a lifestyle improvement program for people with schizophrenia with cognitive dysfunction living in the community |
| Date of disclosure of the study information | 2019/07/07 |
| Last modified on | 2019/07/03 16:53:03 |
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Basic information
Public title
Development of a lifestyle improvement program for people with schizophrenia with cognitive dysfunction living in the community
Acronym
Development of a lifestyle improvement program for people with schizophrenia with cognitive dysfunction living in the community
Scientific Title
Development of a lifestyle improvement program for people with schizophrenia with cognitive dysfunction living in the community
Scientific Title:Acronym
Development of a lifestyle improvement program for people with schizophrenia with cognitive dysfunction living in the community
Region
| Japan |
Condition
Condition
schizophrenia and schizoaffective disorder
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct a lifestyle improvement program for people with schizophrenia with cognitive dysfunction in the community
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Various measured values (weight, BMI, body fat percentage, waist circumference, blood pressure)
Key secondary outcomes
Health habits, social function, spontaneity, self-efficacy, neurocognitive function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
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
16 weeks health consultation (1 hour once a week, once a week) and cognitive training (1 hour once a day, 5 days a week)
Interventions/Control_2
16 weeks health consultation (1 hour once a week, once a week)only
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Underwent a diagnosis of schizophrenia or schizoaffective disorder in the community
(2) Men and women from 40 to 65
(3) People who are obese or overweight
(4) Cognitive dysfunction (MoCA-J 26 points or less)
(5) More than 2 years have passed since diagnosis of schizophrenia or schizoaffective disorder, and both mind and body are stable
(6) Who have been attending to social rehab facility for more than three months
Key exclusion criteria
(1) There is no head injury and no organic disease of the brain
(2) No inappropriate use of alcohol or drug within 6 months before intervention
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | yoshiko |
| Middle name | |
| Last name | FUJIMORI |
Organization
Wakayama medical university
Division name
School of Health and Nursing Science
Zip code
641-0011
Address
Wakayama city, Mikazura 580
TEL
0734466723
fujimori@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | yoshiko |
| Middle name | |
| Last name | FUJIMORI |
Organization
Wakayama medical university
Division name
School of Health and Nursing Science
Zip code
641-0011
Address
Wakayama city, Mikazura 580
TEL
0734466723
Homepage URL
fujimori@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Kobe City College of Nursing
Address
Kobe City, Nishi Ward, Gakuen Nishimachi, 4-3
Tel
078-794-8080
mail@kobe-ccn.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
| 2019 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2019 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042409
