| Protocol ID | NCT06576089 |
| Registration Date | 2024-08-28 |
| Status | recruiting |
| Sponsor | McMaster University |
| Country | Canada |
| Industry | not industry |
| Blinding | blinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2025-06-16 |
| Last Patient Out | 2027-06-30 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT06576089
Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation in Canada - The ORDER Pilot Study
| Field |
OPENAI
gpt-4o Thinking: o3 2616ms / 9877 tok |
GLM
glm-5.1 8235ms / 10029 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5143ms / 11355 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient |
inpatient
inpatient → inpatient → inpatient
shaky reasoning✓ Unanimous
Initial: inpatient
Requery: inpatient — The eligibility criteria specify hemiparesis requiring inpatient rehabilitation, indicating that the intervention is delivered while the patients are admitted for rehabilitation.
Thinking: inpatient — Participants must have hemiparesis requiring inpatient rehabilitation, so the intervention is delivered while they are admitted.
|
inpatient
inpatient → inpatient
shaky reasoning✓ Unanimous
Initial: inpatient
Requery: inpatient — The inclusion criteria explicitly require 'Hemiparesis requiring inpatient rehabilitation' and exclude patients who cannot return to living outside of a facility.
|
inpatient
mixed → outpatient → inpatient
shaky reasoning✓ Unanimous
Initial: mixed
Requery: outpatient — This is a recruitment methodology study where participants are approached 5 days to 8 weeks after stroke to decide about enrollment in a rehabilitation trial, with coordinators making visits to discuss participation but not providing the actual treatment intervention itself.
Thinking: inpatient — Patients must have hemiparesis requiring inpatient rehabilitation and are approached while admitted for stroke rehabilitation.
|
OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility 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 → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial involves the use of a tablet to display videos and information, but the tablet is not the focus of the intervention; it is simply a tool for facilitating information delivery in recruitment.
Thinking: no — Intervention consists of recruitment materials (video, leaflet) and use of a tablet for viewing, not a medical device being evaluated as a therapeutic or diagnostic tool.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This study evaluates a recruitment method using informational videos and leaflets to improve equity in clinical trial enrollment, which does not involve any physical medical devices or hardware.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study uses a mobile tablet as a physical device to deliver recruitment materials including videos and leaflets to participants.
Thinking: no — The study only uses a consumer tablet to display recruitment videos and materials, not any medical devices or monitoring equipment.
|
OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education |
no
no → yes → yes
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The study focuses on an educational component with women-centred and aphasia-friendly videos and leaflets as a primary intervention to optimize recruitment.
Thinking: yes — The ORDER arm’s main intervention is a patient-facing video, leaflet, and guided discussion that educate potential participants about the host trial, making education the primary component.
|
no
no → no
shaky reasoning✗ No consensus
Initial: no
Requery: no — The trial evaluates recruitment strategies using videos and leaflets to improve trial enrollment and informed consent, rather than providing primary patient education or training about stroke management.
|
yes
yes → no → no
shaky reasoning✗ No consensus
Initial: yes
Requery: no — This study tests different recruitment approaches (traditional vs. women-centred/aphasia-friendly materials) to improve enrollment in clinical trials, which is a methodological intervention rather than an educational program for participants.
Thinking: no — This is a recruitment methodology study comparing different ways to present trial information for informed consent, not a patient education intervention.
|
|
| intervention_digital |
no
no → no → yes
shaky reasoning✗ No consensus
Initial: no
Requery: no — The digital component (video and tablet) supplements traditional recruitment methods but is not the primary delivery mechanism of the intervention, which focuses on recruitment methods rather than digital health intervention.
Thinking: yes — The core intervention is a tablet-based, aphasia-friendly video used to recruit participants, so digital media is central to delivering the intervention.
|
yes
yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: no — The study compares a tablet-based recruitment video against traditional paper-based consent methods to determine its effect on patient enrollment, meaning the tablet is merely an alternative delivery mechanism for information rather than a fundamental digital intervention.
|
yes
yes → yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The intervention uses a tablet-delivered video as a core component of the recruitment method, where the digital materials (video and leaflet on tablet) are central to the ORDER intervention arm.
Thinking: no — The video on tablet is a communication tool for recruitment materials, but the core intervention is the women-centred, aphasia-friendly approach which could exist without digital technology.
|
|
| intervention_other |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention focuses on optimizing recruitment strategies for diverse participation in stroke trials, which falls under organizational changes, not any of the specified categories.
|
yes
no
shaky reasoning✓ Unanimous
Initial: no
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — This is an organizational/methodological intervention testing different recruitment strategies (women-centred, aphasia-friendly video and leaflet vs traditional materials) rather than a clinical treatment intervention.
|
OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |