Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062564) titled '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"' on Aug. 13.

Study Type: Observational

Primary Sponsor: Institute - Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital

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 malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 18 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 Size - 35

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 12 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2027 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071617

Disclaimer: Curated by HT Syndication.