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Supporting Treatment Adherence and Resilience in Kids

Supporting Treatment Adherence and Resilience in Kids - STAR KIDS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059392
Enrollment
100
Registered
2025-10-14
Start date
2025-08-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Eczema, Cardiac conditions

Interventions

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 ther

Sponsors

KK Women's and Children's Hospital, SingHealth Duke-NUS, Singapore
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
As this is a supporting treatment adherence study, the primary outcomes are how well the participants follow the treatment plan and associated advice as directed by their doctors (and other healthcare professionals). For appropriate asthma inhaler use, this would be achieved via Medication Possession Ratio, Proportion of Days Covered, Medication Implementation/Adherence Questionnaires, medical record review, etc. For other advice this would be achieved depending on the nature of the advice, for example removal of pets by asking family members/home visit/proxy interviews, shortening of bath time by digital timer, laundry care and allergen control by home visit and purchase proof, food photograph and random checks, etc.

Secondary

MeasureTime frame
Heath-related Quality of Life, Step-up therapy (e.g. via GINA steps review from medical records), Hospitalization and emergency department visit, Qualitative interviews on treatment adherence, Patients' and Providers' evaluation of the intervention/support/tools/education materials, Surveillance, cost analysis, and HTA.

Countries

Asia(except Japan)

Contacts

Public ContactKKH General Enquiry

KK Women's and Children's Hospital, SingHealth Duke-NUS, Singapore Department of Paediatrics

research@kkh.com.sg.+6562255554

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026