UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059392 |
|---|---|
| Receipt number | R000067235 |
| Scientific Title | Supporting Treatment Adherence and Resilience in Kids |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/14 15:47:11 |
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Basic information
Public title
Supporting Treatment Adherence and Resilience in Kids
Acronym
STAR KIDS
Scientific Title
Supporting Treatment Adherence and Resilience in Kids
Scientific Title:Acronym
STAR KIDS
Region
| Asia(except Japan) |
Condition
Condition
Asthma, Eczema, Cardiac conditions
Classification by specialty
| Cardiology | Pneumology | Pediatrics |
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Improvements in patient adherence to treatment plan (inhaler use, topical therapy, oral medication), and their associated advice (exercise, dust/allergen control, environmental control, diet modification, etc.)
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
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.
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
| 2 | years-old | <= |
Age-upper limit
| 20 | 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 sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jean Yin |
| Middle name | |
| Last name | Oh |
Organization
KK Women's and Children's Hospital, SingHealth Duke-NUS, Singapore
Division name
Department of Paediatrics
Zip code
229899
Address
100 Bukit Timah Road
TEL
+6562255554
starkids+research@kkh.com.sg
Public contact
Name of contact person
| 1st name | KKH |
| Middle name | |
| Last name | General Enquiry |
Organization
KK Women's and Children's Hospital, SingHealth Duke-NUS, Singapore
Division name
Department of Paediatrics
Zip code
229899
Address
100 Bukit Timah Road
TEL
+6562255554
Homepage URL
https://www.kkh.com.sg/
research@kkh.com.sg.
Sponsor or person
Institute
KK Women's and Children's Hospital, SingHealth Duke-NUS, Singapore
Institute
Department
Personal name
Funding Source
Organization
Low Tuck Kwong Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Singapore
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SingHealth Centralised Institutional Review Board
Address
10 Hospital Boulevard, #19-01 SingHealth Tower, Singapore 168582
Tel
+6581263660
irb@singhealth.com.sg
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
KK Women's and Children's Hospital (Singapore), SingHealth Duke-NUS Academic Medical Centre (Singapore)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 14 | 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
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067235
