| Protocol ID | NCT06903052 |
| Registration Date | 2025-03-30 |
| Status | recruiting |
| Sponsor | The Hong Kong Polytechnic University |
| Country | Hong Kong |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2025-05-06 |
| Last Patient Out | 2028-04-30 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 2 Years - 18 Years |
NCT06903052
Nurse Parental Support Using a Proactive Mobile App in Symptom Management for Children With Medical Complexity Requiring Mechanical Ventilation: an Effectiveness-implementation Hybrid 2 Study
| Field |
GLM
glm-5.1 7029ms / 8813 tok |
OPENAI
gpt-4o Thinking: o3 4201ms / 8670 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5607ms / 10050 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
home care
home care
shaky reasoning✓ Unanimous
Initial: home care
|
home care
other → home care
shaky reasoning✓ Unanimous
Initial: other
Requery: home care — The intervention involves nurse parental support using a mobile app for symptom management in the child's own home.
|
home care
home care → home care
shaky reasoning✓ Unanimous
Initial: home care
Requery: home care — The intervention involves nurse support using a mobile app for home-based care of children with mechanical ventilation, with parents living at home with their children.
|
OK |
| feasibility |
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study is a single-group quasi-experimental design without randomization, making it an observational study rather than an RCT.
|
N/A
feasibility RCT → N/A → N/A
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: N/A — The study is a single group pre-post quasi-experimental design rather than an RCT.
Thinking: N/A — This is a single-group quasi-experimental study without randomization, therefore not an RCT.
|
N/A
fully powered RCT → feasibility RCT → N/A
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: feasibility RCT — This study explicitly includes implementation evaluation as a primary outcome to assess reach, adoption, implementation, and maintenance of the intervention, which are key feasibility measures, despite having effectiveness outcomes.
Thinking: N/A — Single-arm quasi-experimental study without randomization, not an RCT.
|
OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is a mobile app, which is a software-only tool classified under digital interventions rather than a physical medical device.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention relies solely on a mobile app, which is a software tool without any physical hardware component.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is a proactive mobile app which is software-only and should be classified as intervention_digital rather than intervention_device since it does not involve physical hardware beyond a standard smartphone.
|
OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention involves a single modality, nurse-led support through a mobile app, without distinct interacting components from different categories.
Thinking: no — The intervention is a single‐modality nurse-led supportive/educational program delivered through a mobile app, without combining distinct intervention types from different categories.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention combines nurse support (professional care component) with a proactive mobile app (technology/digital component) for symptom management, representing multiple interacting components from different categories working together.
Thinking: no — This is a single intervention type (nurse-led supportive care/education) delivered through a mobile app platform, not multiple interacting components from different categories.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | yes | yes | yes | OK |
| intervention_education |
yes
yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: no — The intervention is primarily a supportive care program delivered via a mobile application that provides nurse-parent interaction and remote symptom management support, rather than a structured educational or training program.
|
no
no → yes → yes
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The trial primarily focuses on enhancing parental self-efficacy in symptom management through nurse-led educational support using a mobile app, which constitutes an educational intervention.
Thinking: yes — The primary intervention is a nurse-led mobile app that trains and educates parents in symptom management to boost their self-efficacy.
|
yes
yes → yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The intervention is a nurse-led parental support program using a mobile app specifically designed to enhance parental self-efficacy in symptom management, which constitutes a primary educational component for caregivers.
Thinking: no — This is primarily a nurse-led supportive care intervention using a mobile app to enhance parental self-efficacy, not a primarily educational program.
|
|
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | yes | yes | yes | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |