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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032623
Receipt No. R000036967
Scientific Title A Randomized controlled trial on Decision Aid to Support the Stroke with Older People in Decision Making about Location of Care at Recovery Rehabilitation Ward: Efficacy of Decision Conflict and Participation
Date of disclosure of the study information 2019/10/01
Last modified on 2021/03/30

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Basic information
Public title A Randomized controlled trial on Decision Aid to Support the Stroke with Older People in Decision Making about Location of Care at Recovery Rehabilitation Ward: Efficacy of Decision Conflict and Participation
Acronym A Randomized controlled trial on Decision Aid to Support the Stroke with Older People in Decision Making about Location of Care at Recovery Rehabilitation Ward: Efficacy of Decision Conflict and Participation
Scientific Title A Randomized controlled trial on Decision Aid to Support the Stroke with Older People in Decision Making about Location of Care at Recovery Rehabilitation Ward: Efficacy of Decision Conflict and Participation
Scientific Title:Acronym A Randomized controlled trial on Decision Aid to Support the Stroke with Older People in Decision Making about Location of Care at Recovery Rehabilitation Ward: Efficacy of Decision Conflict and Participation
Region
Japan

Condition
Condition Stroke
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this research, we developed decision aid for the location of care based on the values of the stroke with older people and families. We aims to verify the effect to the conflict and participation of decision making by randomized comparative test.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decision Conflict Scale
Key secondary outcomes Control Preference Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Provide decision aid
Interventions/Control_2 Confirm the practical use of decision making aid
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) older people aged over 65 years, 2) person who is suffering from stroke (cerebral infarction, stroke, subarachnoid hemorrhage), 3) they are hospitalized in the recovery period rehabilitation ward, and face decision-making decisions in hospital setting 4) Person who the physician judged informed consent is possible, 5) Person who can read and write Japanese
Key exclusion criteria Those who have difficulty making their own decisions due to severe dementia, aphasia, disturbance of consciousness
Target sample size 122

Research contact person
Name of lead principal investigator
1st name Yoriko
Middle name
Last name Aoki
Organization Toyama university
Division name Dept. of Gerontological Nursing Graduate School of Medicine and Pharmaceutical Sciences for Research
Zip code 930-0194
Address 2630 Sugitani, Toyama-shi, Toyama-ken
TEL 076-434-7420
Email yoriko18@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name Yoriko
Middle name
Last name Aoki
Organization Toyama university
Division name Dept. of Gerontological Nursing Graduate School of Medicine and Pharmaceutical Sciences for Research
Zip code 930-0194
Address 2630 Sugitani, Toyama-shi, Toyama-ken
TEL 076-434-7420
Homepage URL
Email yoriko18@med.u-toyama.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

Funding Source
Organization Ministray of education, culture, sports, science and technology-Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Toyama Prefectural Rehabilitation Hospital & Support Center for Children with Disabilities
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Information Department, Toyama university
Address 2630 Sugitani, Toyama-shi, Toyama-ken
Tel 076-434-7097
Email johoku-tym@umin.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 富山県リハビリテーション病院・こども支援センター(富山県)

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 01 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 135
Results Decision aid resulted in significantly less conflict at discharge compared to at hospitalization with respect to sufficient explanation of information, support, uncertainty and effective decision making. Moreover, there was significantly less conflict in the intervention group compared to the control group with respect to effective decision making for a high level of conflict, and uncertainty for not prepared to make decisions. However, the decision aid had no effect on increasing participation.
Results date posted
2021 Year 03 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The duration of hospitalization for the study participants was 71.2 days in the guided group and 75.4 days in the unguided group. There was no significant difference in age, and there were more males in the gender group. The most common family structure in both groups was two people living together (42.6% in the group with aid and 37.8% in the group without aid). The majority of patients in both groups had cerebral infarction (68.8% in the presence group and 71.1% in the absence group). In terms of employment history, before retirement, the majority were company employees (58.4% in the guided group and 55.3% in the unguided group), followed by self-employed (18.8% in the guided group and 15.8% in the unguided group). The most common final education was high school graduate (58.3% in the guided group and 50.0% in the unguided group). In terms of readiness to make a decision, both groups were polarized into "already decided where to discharge" (70.8% in the guided group and 42.1% in the unguided group) or "have no time to think about where to discharge" (14.6% in the guided group and 36.8% in the unguided group).
Participant flow When a patient who met the eligibility criteria was admitted to the hospital, he or she was referred by the ward manager, and after receiving the patient's consent, the principal investigator blinded the study participants to the inclusion of the patient, while following the allocation chart for each ward. The intervention period was approximately 2 months from admission to discharge. The intervention consisted of the provision of the decision aid to the group with the aid and confirmation of its use approximately one month after admission, and the provision of an information-only booklet to the group without the aid and confirmation of its use approximately one month after admission. In addition, both groups answered the questionnaire twice, at the time of admission and at the time of discharge, together with a research assistant.
Adverse events
Outcome measures Decision conflict scale
Control preference scale
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 07 Month 31 Day
Date of IRB
2018 Year 08 Month 15 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 05 Month 17 Day
Last modified on
2021 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036967

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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