Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059392) titled 'Supporting Treatment Adherence and Resilience in Kids' on Oct. 14.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - KK Women's and Children's Hospital, SingHealth Duke-NUS, Singapore

Condition: Condition - Asthma, Eczema, Cardiac conditions Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The goal of the STAR KIDS (Supporting Treatment Adherence and Resilience in Kids) research is to promote better adherence to treatment plan and advice among paediatric patients (particularly children with asthma, eczema, and cardiac condition) and their families. The needs assessment aims to provide initial insight on experiences, barriers, facilitators, and suggested improvements or new initiatives related to treatment adherence by means of interviewing children, parents, as well as Healthcare Professionals (HCPs). The results of the needs assessment will be used to create interventions/education materials/support programmes/tools with the goal to improve the quality of life and health-related outcomes of children. Basic objectives2 - Others

Intervention: Interventions/Control_1 - The intervention is additional resources/supports/tools to facilitate adherence to treatment plan based on the results of a formal needs assessment. This may include home visit, directly observed therapy to improve inhaler technique, teleconsultations, help-line via chat, educational material, medication delivery, dietitian support, subsidy/cost adjustments, etc.

Eligibility: Age-lower limit - 2 years-old = Gender - Male and Female Key inclusion criteria - 1. Must have an established diagnosis of asthma, atopic dermatitis or eczema, or a cardiac condition requiring long-term Warfarin therapy (e.g., atrial fibrillation, cardiac valve-related condition/replacement, post-Fontan operation). 2. Must be receiving the treatment of interest (inhaled corticosteroids for asthma, any topical treatment for atopic dermatitis or eczema, or Warfarin therapy for a cardiac condition), in KKH. 3. Must be aged 10 to 20 years 4. Singapore Citizen or Singapore Permanent Resident 5. Able to communicate in English 6. The participant must provide consent to be interviewed at least three times: the first interview will be conducted face-to-face, and the subsequent interviews will be at three months and six months, which may be face-to-face or via phone calls, depending on the participant's preference. 7. The participant must provide consent for the interviews to be audio-recorded. Key exclusion criteria - 1. The participant has a plan to move overseas within the next six months. 2. The participant has an unfavorable prognosis with a life expectancy of less than 24 months. 3. The participant is involved in other research or clinical trials that could interfere with the study's data collection or analysis. 4. The participant has significant cognitive or communication impairments that would hinder effective participation in interviews or the informed consent process. Target Size - 100

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 08 Month 08 Day Date of IRB - 2025 Year 08 Month 08 Day Anticipated trial start date - 2025 Year 08 Month 24 Day Last follow-up date - 2028 Year 08 Month 24 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067235

Disclaimer: Curated by HT Syndication.