UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of consent capacity and decision making support for older patients with schizophrenia
Title of the study (Brief title)	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	Yuka Kato
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name	Department of Psychiatry
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5612
Email	y-kato@koto.kpu-m.ac.jp

Public contact
Name of contact person	Yuka Kato
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name	Department of Psychiatry
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5612
Homepage URL
Email	y-kato@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Psychiatry, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.igaku-shoin.co.jp/journalDetail.do?journal=37731
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027021