UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048991 |
|---|---|
| Receipt number | R000055146 |
| Scientific Title | Associations between depression, work productivity and walking activity: a retrospective observational study in Japan |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/10/31 10:25:43 |
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Basic information
Public title
Associations between depression, work productivity and walking activity: a retrospective observational study in Japan
Acronym
Associations between depression, work productivity and walking activity: a retrospective observational study in Japan
Scientific Title
Associations between depression, work productivity and walking activity: a retrospective observational study in Japan
Scientific Title:Acronym
Associations between depression, work productivity and walking activity: a retrospective observational study in Japan
Region
| Japan |
Condition
Condition
Major depressive disorder (MDD)
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the association between continuously measured walking activity and MDD development or work productivity impairment, and to validate walking activity as an objective marker of MDD-related work productivity impairment.
Basic objectives2
Others
Basic objectives -Others
Data base research with Web-based questionnaire
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
MDD diagnosis (a surrogate indicator of MDD development, defined by using ICD-10 code) and the number of step.
Key secondary outcomes
[Web-based questionnaire]
Work productivity impairment measured by Work Productivity and Activity Impairment Questionnaire (WPAI) and Work Functioning impairment scale (WFun)
Severity of depressive symptom measured by Patient Health Questionnaire-9 (PHQ-9)
Level of anhedonia measured by Snaith-Hamilton Pleasure Scale (SHAPS)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study subjects will be selected from those who can be identified in the claims database and have step count data.
The data period in the DeSC database: from April 1, 2015 to August 31, 2021.
Eligibility criteria for each analysis are listed in the next section.
< Analysis 1 >
- To have a record of MDD diagnosis (identified by ICD-10 code of F32-F33).
- To have step count data throughout the analysis period.
< Analysis 2 >
- Insured person (this means that dependents of insured person will not be included in the analysis).
- To have WPAI data at least two time points.
- To have step count data during all analysis periods which correspond to each subject's WPAI data points.
< Analyses 3, 4 >
- Insured person.
- To have WFun data.
- To have step count data during the analysis period.
Key exclusion criteria
< Analysis 1 >
- To have any record of the following diseases or events during the analysis period: Cancer (ICD-10 code of C00-C97), bipolar disorder (F31), dialysis (identified by searching medical
procedures which include a word ""Dialysis"").
< Analysis 2 >
- To have any record of the following diseases or events during the analysis period: Cancer (ICD-10 code of C00-C97), fracture (S02, S12, S22, S32, S42, S52, S62, S72, S82, S92, T02), bipolar disorder (F31), dialysis (identified by searching medical procedures which include a word ""Dialysis""), hospitalization.
< Analyses 3, 4 >
- To have any record of the following diseases or events during the analysis period: Cancer (ICD-10 code of C00-C97), fracture (S02, S12, S22, S32, S42, S52, S62, S72, S82, S92, T02), bipolar disorder (F31), dialysis (identified by searching medical procedures which include a word ""Dialysis""), hospitalization.
- Those who do not carry their smartphone regularly (can be identified by questionnaire)
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Fujikawa |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3242-1256
keita.fujikawa@takeda.com
Public contact
Name of contact person
| 1st name | Fumie |
| Middle name | |
| Last name | Tokuda |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3242-1256
Homepage URL
fumie.tokuda@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute of Healthcare Data Science
Address
2-5-5, Shibadaimon, Minato-ku, Tokyo, 105-0012, Japan
Tel
03-5733-5010
rihds@jmdc.co.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
| 2022 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fpubh.2023.1190464/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fpubh.2023.1190464/full
Number of participants that the trial has enrolled
2143
Results
The 7-day moving average step count decreased from 6,310 at day -60 to 5,879 at the index date (first recorded MDD-related visit), and then increased to 6,062 at day +60. Compared with the index date, the 7-day moving average of step counts was significantly higher at days -60 to -1, +23 to +33, and +42 to +60, and significantly lower at days +2 and +3. Joinpoint regression analysis of 7-day moving average step counts from day -60 to day 0 identified an inflection point at day -14.
Results date posted
| 2023 | Year | 10 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 28 | Day |
Baseline Characteristics
Among the 2,143 patients included in the present study, the proportion of men (69.5%) was higher than the proportion of women (30.5%). The mean age of included patients was 41.2 (SD: 10.6) years. Most patients were on their own health insurance plan (94.1%) and over half (59.2%) were prescribed antidepressants during the analysis period. The most common comorbidities were hypertension (12.1%), chronic lower respiratory disease (11.6%) and diabetes mellitus (6.7%). Few patients had conditions that could have affected their step counts, such as bone fractures, osteoporosis or arthritis (< 3% per condition).
Participant flow
We used longitudinal data on health insurance claims and routine health examinations from over 550,000 people enrolled in employment insurance at approximately 80 health insurance associations located across various regions of Japan. In addition, daily step count data were collected from over 150,000 of the insured individuals and their dependents who are enrolled in health service apps provided by the health insurance associations. Of these approximately 150,000 individuals, both the health insurance claims and step count data for the period between April 1, 2014 and August 31, 2021 were obtained for 118,161 individuals.
Of this number, 6644 individuals were aged 20-74 years and had a record of MDD diagnosis (International Classification of Diseases (ICD) 10 codes F32-F33). After excluding those without step count data for the 60 days before and after the date of the first recorded MDD-related visit (n=3,463), those with missing step count data on 7 or more consecutive days (n=909), and those with records of cancer (ICD-10 codes C00-C97), bipolar disorder (F31) or dialysis (identified by searching for the term 'dialysis' in Japanese in medical procedure records) (n=174), data from 2143 patients were available for the present analysis.
Adverse events
NA
Outcome measures
The 7-day moving average of step counts.
The 7-day moving average of step counts was calculated for each day of the analysis period. Step counts on the index date were excluded from the calculation, as were step counts on days when fewer than 50 steps were recorded, on the assumption that fewer than 50 steps would indicate that the individual was not carrying a smartphone on that day. Missing data were not imputed. Days for which step count data were not available were excluded from the moving average calculation.
Multivariate regression analysis was conducted using generalized estimating equations (GEEs) to compare 7-day moving averages of step counts on each day with the mean step count on the index date. For GEEs, a binomial distribution (log link) was specified as a fixed value for the error structure, and the Quasi-Likelihood Information Criterion (QIC) selected autoregressive (smallest QIC score) for the correlation structure. Covariates (age, sex, comorbidity, year and month when step count data were acquired, participation in walking campaigns, hospitalization events and antidepressant prescriptions) were included in the model to correct for potential confounding. The duration of participation in walking campaigns was included as a covariate, because the number of steps was likely to be affected by participation in such campaigns.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Associations between depression, work productivity and walking activity: a retrospective observational study in Japan
Management information
Registered date
| 2022 | Year | 09 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055146
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