UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023482 |
|---|---|
| Receipt number | R000027021 |
| Scientific Title | The evaluation of consent capacity and decision making support for older patients with schizophrenia |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2018/02/05 09:48:59 |
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Basic information
Public title
The evaluation of consent capacity and decision making support for older patients with schizophrenia
Acronym
The evaluation of consent capacity and decision making support for older patients with schizophrenia
Scientific Title
The evaluation of consent capacity and decision making support for older patients with schizophrenia
Scientific Title:Acronym
The evaluation of consent capacity and decision making support for older patients with schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of decision making support for older patients with schizophrenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MacArthur Competence Assessment (MacCAT-T)
Key secondary outcomes
Mini-Mental State Examination
Executive Interview
Executive Clock Drawing Task
Wechsler Memory Scale-Revised
Brief Psychiatric Rating Scale
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Other |
Interventions/Control_1
For the subjects who performed poorly on the evaluation of consent capacity (MacCAT-T) about antipsychotic treatment, we provide educational intervention and visual teaching materials.
Intervention time: After evaluation of consent capacity for 1 months, once approximately from 30 minutes.
Interventions/Control_2
For the subjects who performed poorly on the evaluation of consent capacity (MacCAT-T) about hyperlipemic treatment, we provide educational intervention and visual teaching materials.
Intervention time: After evaluation of consent capacity for 1 months, once approximately from 30 minutes.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Institutionalized patients
2. Over 60 years
3. During treatment or treatment plan of Hyperlipidemia
4. Patients who have written consent for the study protocol
Key exclusion criteria
1. Dementia
2. Past history of traumatic brain injury, alcohol or other substance abuse
3. Mental illness
4. Persons with severe impairment of visual acuity, auditory sensor and/or communication
5. The patient of the cognitive state who can't stand MacCAT-T
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka Kato |
Organization
Graduate School of Medical Science,
Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
y-kato@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Kato |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
Homepage URL
y-kato@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitayama Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北山病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.igaku-shoin.co.jp/journalDetail.do?journal=37731
Number of participants that the trial has enrolled
Results
OBJECTIVE: To clarify the difference between the consent capacity to antipsychotic treatment and hyperlipemic treatment, and the effect of the decision aid, the visual teaching material, on consent capacity.
METHODS: We recruited older institutionalized patients with chronic schizophrenia under treatment or treatment plan of hyperlipidemia(n=7). Baseline measures included the neurocognitive tests and brief psychiatric rating scale and the MacArthur Competence Assessment Tool for Treatment(MacCAT-T). The order of capacity assessment was randomly assigned to remove an order effect. We readministered the MacCAT-T with the decision aid one month later. The differences of the score in the MacCAT-T between treatments and improvement of the score of the MacCAT-T by using the decision aid were analyzed using t test. The study was approved by the Ethics Committee of Kyoto Prefectural University of Medicine.
RESULTS: "Reasoning" and "Comparison of the result" scores in the MacCAT-T were significantly higher in antipsychotic treatment than hyperlipemic treatment. Furthermore, "Understanding of the disease" and "Understanding of the substitute treatment" score in antipsychotic treatment, and "Understanding", "Understanding of the treatment", "Benefits and disadvantages of the treatment", "Understanding of the substitute treatment" and "Recognition of the treatment" scores in hyperlipemic treatment were significantly improved by using the decision aid.
CONCLUSION: Better reasoning in antipsychotic treatment may reflect that the treatment effect is easy to recognize in the antipsychotic treatment than hyperlipemic treatment. The decision aid may help their understanding of the treatment and the substitute treatment through the compensation of working memory deterioration.
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2018 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027021
