| Protocol ID | NCT05515991 |
| Registration Date | 2022-08-25 |
| Status | active, not recruiting |
| Sponsor | University Health Network, Toronto |
| Country | Canada |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2023-04-19 |
| Last Patient Out | 2025-12-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT05515991
Assessing the Feasibility of Self-reported MeasUrement of Physical and PsychosOcial Symptoms and Response Tool in Patients on Dialysis- Pilot Study
| Field |
GLM
glm-5.1 10857ms / 9925 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 10241ms / 11246 tok |
OPENAI
gpt-4o Thinking: o3 3411ms / 9756 tok |
Review |
|---|---|---|---|---|
| rct_type |
N/A
parallel RCT → N/A
shaky reasoning✓ Unanimous
Initial: parallel RCT
Requery: N/A — The study design is explicitly listed as Allocation: NON_RANDOMIZED, meaning participants were not randomly assigned to the interventions.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study explicitly states allocation as 'NON_RANDOMIZED' and describes assignment based on dialysis centers rather than individual randomization.
|
N/A
parallel RCT → N/A
shaky reasoning✓ Unanimous
Initial: parallel RCT
Requery: N/A — The trial describes an allocation model as non-randomized, so no randomization design is described.
|
OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | renal | renal | renal | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
other
shaky reasoning✓ Unanimous
Initial: other
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention is delivered at dialysis centers during patients' dialysis treatments, which are specialized outpatient facilities, not inpatient hospital wards.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention is delivered in dialysis centers, not requiring hospital admission or inpatient care.
|
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 | 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 | yes | yes | yes | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education |
no
no → yes
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The primary intervention includes a self-management support and decision support information hub to facilitate symptom management, which classifies as a primary educational component.
|
no
no → no → no
shaky reasoning✗ No consensus
Initial: no
Requery: no — This intervention primarily involves electronic symptom screening and monitoring with decision support tools, rather than educational or training programs for patients or healthcare providers.
Thinking: no — While the intervention includes access to a self-management information hub, the primary focus is on symptom screening/monitoring using ePROMs with the information resources serving as a support tool rather than the main intervention.
|
yes
yes → yes → yes
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The primary component of the intervention is a self-management support and information hub aimed at facilitating symptom management for patients, which is an educational/training program.
Thinking: yes — The main intervention is access to a self-management and decision-support information hub that educates patients and clinicians on symptom management.
|
|
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom |
yes
no
shaky reasoning✓ Unanimous
Initial: no
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study uses PROMIS CAT (Patient Reported Outcome Measurement Information System Computer Adaptive Testing) surveys to assess physical and psychological symptoms including chronic pain, itchiness, fatigue, anxiety, depression and sleep disturbances in dialysis patients.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial measures physical and psychosocial symptoms using electronic patient reported outcome measures (ePROMs), specifically targeting symptoms like chronic pain, fatigue, anxiety, and depression, which are identified as symptom measures.
|
OK |
| outcome_qol | yes | yes | yes | 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 |