UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032623 |
|---|---|
| Receipt number | 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 | 2024/01/29 14:54:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 decision-making roles, a 10-point Visual Analog Scale for participation rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
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
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
yoriko18@med.u-toyama.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Yoriko Aoki
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
Japan
Other related organizations
Co-sponsor
Toyama Prefectural Rehabilitation Hospital & Support Center for Children with Disabilities
Name of secondary funder(s)
Tamura Science and Technology Foundation
IRB Contact (For public release)
Organization
Medical Information Department, Toyama university
Address
2630 Sugitani, Toyama-shi, Toyama-ken
Tel
076-434-7097
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
https://onlinelibrary.wiley.com/doi/10.1111/2047-3095.12393
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0272115
Number of participants that the trial has enrolled
107
Results
Ninety-nine participants (intervention n = 51; control n = 48) were in the analysis. No significant differences in decision-making conflict [t (99) = 0.69, p = 0.49] and roles [chi-square (5) = 3.65, p = 0.46] were found. However, a significant difference in participation rate [t (99) = 2.24, p = 0.03] was observed. Decision aid helped reduce uncertainty and improve participation, especially for participants living alone and unsure about their discharge destination.
Results date posted
| 2021 | Year | 03 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 25 | Day |
Baseline Characteristics
Characteristics of the participants summarizes the characteristics of the participants at baseline. The participants were hospitalized for an average duration of 73.2 days (SD = 35.6) for the intervention group and 87.4 days (SD = 43.4) for the control group. The average age of the participants was 75.5 years (SD = 6.6) in the intervention group and 75.5 years (SD = 6.6) in the control group. In terms of the status of readiness for decision-making, in the intervention group, 66.7% had already decided on their discharge destination and 45.8% had done so in the control group. The discharge destination was the same place as before admission in 65.7% of the participants and a different place in 34.3% of the participants. Regarding whom the participants wanted to decide their discharge destination, the largest number of the participants wanted to do so 'With their family,' followed by 'With family and healthcare professionals.' We found that the intervention group contained significantly more participants who had already decided their discharge destination than the control group (p < 0.05). It was also found that significantly more participants chose 'the same place as before admission' as their discharge destination (p < 0.01).
Participant flow
Based on the prescribed facility criteria and preliminary survey, we found that the third and fourth floors were similar and concluded the baseline conditions to be the same for both in terms of patient gender, age, severity of illness, and the ratio of the number of stroke patients. Approximately two weeks after admission to the rehabilitation hospital, when the patients had familiarized themselves with their hospital environment, those who met the eligibility criteria were introduced to us by the head nurse. The principal investigator described the outline of the study orally to the patients, using an explanatory document. The participants were enrolled in the study after they provided written informed consent. While following the allocation table, the principal investigator randomly allocated the participants to the intervention or the control groups according to the hospital room where the initial meeting with the research participants had occurred. The principal investigator created a table by integrating (a) a random number table that Research Assistant A had created using a computer at a 1:1 ratio and (b) an allocation table of patients according to their condition's severity designed by the ward's head nurse. The severity of illness was determined by the lowest total score of a daily living function assessment and the Functional Independence Measure (FIM). According to the facility criteria prescribed by the government, the severely ill are those who have a daily living function assessment of 10 points or more, or a total FIM score of 55 points or less. Until the allocation to the groups was completed, the order of allocation was concealed from Research Assistant A, the floor's head nurse, the patients, their families, and multidisciplinary professionals (as part of the 'allocation concealment mechanism').
Adverse events
No adverse events
Outcome measures
Decision conflict scale
Control preference scale
The participation rate
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
| 2023 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.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 |
