UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052128 |
|---|---|
| Receipt number | R000059496 |
| Scientific Title | Assessing the validity and reliability of the INTERMED self-assessment questionnaire in adult outpatients |
| Date of disclosure of the study information | 2023/09/07 |
| Last modified on | 2024/06/05 20:36:28 |
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Basic information
Public title
Assessing the validity and reliability of the INTERMED self-assessment questionnaire in adult outpatients
Acronym
IMSA Japanease
Scientific Title
Assessing the validity and reliability of the INTERMED self-assessment questionnaire in adult outpatients
Scientific Title:Acronym
IMSA Japanease
Region
| Japan |
Condition
Condition
Not specified
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the reliability and validity of the Japanese version of IMSA.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to evaluate the reliability and validity of the Japanese version of the self-administered INTERMED (IMSA). If both reliability and validity are found to be acceptable, the use of the IMSA in Japan will be promoted. By using the IMSA, which is a relatively simple measure of complexity, it will be possible to more easily investigate the baseline level of complexity in the Japanese population, its relationship to diagnosis, its relationship to consultation time and number of return visits, and its relationship to length of hospital stay. This may lead to social recognition of patient complexity, which may lead to good outcomes, such as shorter hospital stays, by allocating medical resources to high-complexity patients at an early stage.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint:
Reliability:
Internal consistency: Cronbach's alpha for INTEMED self-assessment (IMSA)
Validity:
Criterion-related validity: IMSA total score vs. INTEMED (IM) total score
Structural Conceptual Validity
Structural validity: Charlson Comorbidity Index (CCI) cutoffs (0, 1-5, 6-) vs. total IMSA score
Hypothesis testing:
IMSA total score vs. WHOQOL-26 total score
IMSA body domain score vs. IM body domain score
IMSA Somatic Domain Score vs. CCI Score
IMSA Physical Domain Score vs. WHOQOL-26 Physical Domain Score
IMSA Mental Domain Score vs. IM Mental Domain Score
IMSA Mental Domain Score vs.Hospital Anxiety and Depression Scale (HADS) Score
IMSA Mental Domain Score vs. WHOQOL-26 Psychological Domain Score
IMSA Social Domain Score vs. IM Social Domain Score
IMSA Social Domain Score vs. Japanese Version of Duke Social Support Index (DSSI-J) Score
IMSA Social Domain Score vs. WHOQOL-26 Social Relationships Score
IMSA Health Care System Domain Score vs. IM Health Care System Domain Score
IMSA Health Care System Domain Score vs. WHOQOL-26 Environmental Domain Score
Content validity: Surface validity: Feasibility questionnaire, time to administer the IMSA
Inter-rater agreement of interviews: kappa value
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person who meets all of the following conditions
1) Persons who are 18 years of age or older at the time of consent
2) Patients who have visited the outpatient clinic of the Department of General Medicine, Chiba University Hospital
3) Patients who have received a full explanation of their participation in this study, and who have obtained written consent of their own free will from the patient or a surrogate, based on full understanding.
Key exclusion criteria
A person who meets either of the following 1) or 2)
1) When the following (a) and (b) are met
(a) The subject does not have the ability to understand and respond to the interview or questionnaire.
(b) There is no substitute who understands the interview or questionnaire and can give consent or answer the questionnaire on behalf of the subject.
2) Patients whom the principal investigator determines to be inappropriate as subjects
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masatomi |
| Middle name | |
| Last name | Ikusaka |
Organization
Chiba University Hospital
Division name
department of general medicine
Zip code
2608677
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba pref.
TEL
043-222-7171
chiba_u_soshin@mac.com
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Yokokawa |
Organization
Chiba University Hospital
Division name
department of general medicine
Zip code
2608677
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba pref.
TEL
043-222-7171
Homepage URL
dyokokawa6@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Primary Care Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Observational Studies of Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba pref.
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
| 2023 | Year | 09 | 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
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Design: Prospective cross-sectional study
The flow of the study:
Subjects will undergo a questionnaire and interview at the outpatient clinic of the Department of General Medicine. The consultation at the outpatient clinic of the Department of General Medicine is conducted by several physicians. First, the primary care physician examines the patient for approximately one hour, and then the patient waits for one hour to discuss the details of the case with a senior physician (consultation time). Next, the patient is seen by a senior physician for another hour, which may require additional time to review the details of the case. This consultation time exists as "waiting time" for patients, and this study will use this time to conduct interviews and questionnaires.
The allocation method will be used to ensure that the target population is of a gender and age group that is not being filled. The study will be outlined in writing at the outpatient reception desk, and willingness to participate in the study will be confirmed. If willingness to participate is confirmed, the outpatient receptionist will contact the research staff. During the "waiting period," the researcher takes the patient who has indicated willingness to participate to the examination room and explains the study in writing and orally. At this time, consent or non-consent to the research will be confirmed, and if consent is given, the patient will be asked to fill out a consent form. After confirming consent, interviews (IM and CCI) will be conducted directly. After the interview, a set of self-administered questionnaires (IMSA, HADS, DSSI-J, WHOQOL-26, and original questionnaire) with a research ID will be handed to the patient to fill out in the waiting hallway or elsewhere. Once completed, the questionnaires should be returned to the receptionist. The returned questionnaires will be received, stored, and analyzed by the researcher.
Management information
Registered date
| 2023 | Year | 09 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059496
