UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062564 |
|---|---|
| Receipt number | R000071617 |
| Scientific Title | A prospective single-center observational study evaluating the impact of the patient support program "Ashita Assist" on patient experience and nerandomilast treatment persistence in patients with interstitial lung disease |
| Date of disclosure of the study information | 2026/08/13 |
| Last modified on | 2026/08/12 16:56:01 |
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Basic information
Public title
A prospective single-center observational study evaluating the patient experience and impact on the persistence of nerandomilast treatment in a patient support program for patients with interstitial lung disease: "Ashita Assist"
Acronym
ASIST-ILD Study
Scientific Title
A prospective single-center observational study evaluating the impact of the patient support program "Ashita Assist" on patient experience and nerandomilast treatment persistence in patients with interstitial lung disease
Scientific Title:Acronym
ASIST-ILD
Region
| Japan |
Condition
Condition
Adult patients with interstitial lung disease at Himeji St. Mary's Hospital who are newly initiated on nerandomilast, switched from nintedanib to nerandomilast, or have nerandomilast added to nintedanib, and who are newly registered in the "Ashita Assist" patient support program
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary Objective
To evaluate the patient experience at 12 weeks after registration in "Ashita Assist" based on the response distribution for each item of AAPSEQ Q3 to Q16, and to clarify the overall satisfaction (Q14) as a representative item.
Secondary Objectives
1.To evaluate operability, clarity and reliability of information, understanding of the disease and treatment, self-management support, sense of security, ease of consultation, motivation for treatment persistence, overall satisfaction, intention for continued use, and intention to recommend at 4 and 12 weeks after registration.
2.To exploratory examine changes in each item from 4 to 12 weeks.
3.To clarify the frequency of use and the features utilized.
4.To clarify the status of nerandomilast and nintedanib continuation, temporary interruption, dose modification, and discontinuation.
5.To explore aspects perceived as useful by patients and areas requested for improvement from free-text comments.
Exploratory Objectives
To descriptively analyze trends in AAPSEQ responses and treatment continuation status according to the mode of nerandomilast initiation, starting dose, and presence or absence of initial dose reduction. In addition, to explore and describe the relationship between AAPSEQ Q13 ("motivation to continue treatment") and actual nerandomilast treatment persistence at 12 weeks after registration.
Basic objectives2
Others
Basic objectives -Others
List of AAPSEQ Evaluation Items
| Q1 | Frequency of use |
| Q2 | Features utilized |
| Q3 | Ease of operation |
| Q4 | Legibility of screens and text |
| Q5 | Ease of finding necessary information |
| Q6 | Clarity of information |
| Q7 | Trustworthiness of information |
| Q8 | Deepening of understanding regarding disease and treatment |
| Q9 | Usefulness in coping with the disease in daily life |
| Q10 | Usefulness in reviewing treatment status and physical condition |
| Q11 | Sense of security in medical/daily care life |
| Q12 | Ease of consultation regarding disease, treatment, and daily life |
| Q13 | Motivation to continue treatment |
| Q14 | Overall satisfaction |
| Q15 | Intention for future use |
| Q16 | Intention to recommend to other patients with the same disease |
| Q17 | Most helpful aspects |
| Q18 | Points for improvement / Requested additional features |
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response distribution and proportion of positive responses for each item of AAPSEQ Q3 to Q16 at 12 weeks post-registration, as well as the response distribution, median, interquartile range, and proportion of positive responses for Q14 ("Overall satisfaction").
Key secondary outcomes
1. Response distribution and proportion of positive responses for AAPSEQ Q3 to Q16 at 4 weeks post-registration
2. Changes in each item from 4 to 12 weeks
3. Frequency of use (Q1) and utilization rates of each feature (Q2)
4. Free-text responses for Q17 and Q18
5. Persistence rates of nerandomilast treatment at 4 and 12 weeks
6. Rates and reasons for temporary interruption, dose reduction, dose increase, and discontinuation of nerandomilast and nintedanib
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Outpatients visiting the Department of Respiratory Medicine at Himeji St. Mary's Hospital.
2. Diagnosed with interstitial lung disease and scheduled to undergo one of the following as routine clinical practice: (1) new initiation of nerandomilast, (2) switching from nintedanib to nerandomilast, or (3) adding nerandomilast to nintedanib therapy.
3. Newly registered in "Ashita Assist" on or after the study approval date.
4. Aged 18 years or older at the time of consent acquisition.
5. Capable of responding to the questionnaire in Japanese.
6. Written informed consent to participate in the study obtained from the patient.
Key exclusion criteria
7.Determined to have difficulty understanding the study content or responding to the questionnaire due to cognitive impairment, altered state of consciousness, or severe physical condition.
8.Registration in "Ashita Assist" is not completed by 4 weeks post-registration.
9.Participation in other studies, etc., that may have a significant impact on the patient-reported evaluations of this study.
10.Otherwise judged by the principal investigator or sub-investigator to be inappropriate for participation in this study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Division name
Department of Respiratory Medicine
Zip code
670-0801
Address
650 Nitoyono, Himeji City, Hyogo Prefecture
TEL
0792655111
nakajima-y@himemaria.or.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Division name
Department of Respiratory Medicine
Zip code
670-0801
Address
650 Nibuno, Himeji, Hyogo, Japan
TEL
0792655111
Homepage URL
nakajima-y@himemaria.or.jp
Sponsor or person
Institute
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Institute
Department
Personal name
Yasuhiro Nakajima
Funding Source
Organization
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee
Address
650 Nibuno, Himeji, Hyogo, Japan
Tel
0792655111
di@himemaria.or.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
| 2026 | Year | 08 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
1. Informed Consent and Registration
The principal investigator or sub-investigators will use the informed consent form approved by the Institutional Review Board to explain the study purpose, methods, burden on the patient, handling of personal information, and the voluntary nature of participation, and will obtain written informed consent based on the patient's free will. After obtaining consent, eligibility will be confirmed, and a study subject identification number will be assigned.
2. Observation Items
At Registration
Age, gender, height, weight, BMI
ILD diagnosis and subtype, date of diagnosis, smoking history
Nerandomilast initiation mode, date of initiation, starting dose, planned dose, reason for dose selection, and treatment status
Duration of treatment, dose, and treatment status for cases of nintedanib co-administration or switching
Comorbidities, home oxygen therapy, and concomitant medications
Most recent FVC, %FVC, DLco, or %DLco measured during routine clinical practice
"Ashita Assist" registration date and registration method
At 4 and 12 Weeks
AAPSEQ Q1 to Q18
Status and reasons for continuation, temporary interruption, dose reduction, dose increase, or discontinuation of nerandomilast and nintedanib
Major adverse events captured during routine clinical practice
3. Implementation of AAPSEQ
The AAPSEQ is an 18-item patient-reported questionnaire developed for this study. In principle, the questionnaire will be distributed and collected in paper format during outpatient visits. If a patient does not visit the clinic within the permissible timeframe, it may be distributed and collected by mail using methods approved by the IRB. The patient must complete the questionnaire themselves, and medical staff shall not influence the responses. The actual date of completion must be recorded.
Management information
Registered date
| 2026 | Year | 08 | Month | 12 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071617
