| Protocol ID | NCT04347759 |
| Registration Date | 2020-04-15 |
| Status | recruiting |
| Sponsor | Emory University |
| Country | United States |
| Industry | not industry |
| Blinding | blinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2023-02-12 |
| Last Patient Out | 2026-04-30 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT04347759
Symptom Care at Home-Heart Failure: Developing and Piloting a Symptom Monitoring and Self-Management Coaching System for Patients With Heart Failure
| Field |
GLM
glm-5.1 7329ms / 8961 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5005ms / 10234 tok |
OPENAI
gpt-4o Thinking: o3 3947ms / 8823 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | cardiac | cardiac | cardiac | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | home care | home care | home 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
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is a single-modality behavioral system that integrates automated symptom monitoring with self-management coaching within one technological platform.
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This is a single behavioral intervention using an automated telephone system that combines symptom monitoring with coaching messages, both delivered through the same technology platform and representing one integrated behavioral approach rather than multiple distinct intervention types.
Thinking: no — This is a single technology-based behavioral intervention (IVR system) with monitoring and coaching functions, not multiple distinct intervention types from different categories.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention involves a behavioral component (real-time self-management coaching) and a technology component (automated daily symptom monitoring), which are distinct and interact with each other to deliver personalized care based on patient-reported outcomes.
Thinking: no — The intervention combines daily symptom monitoring with automated self-management coaching, both behavioral/educational elements within a single modality rather than distinct categories.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is a behavioral intervention testing an automated symptom monitoring and self-management coaching system for heart failure patients, not a palliative care consultation or service delivery intervention.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial focuses on symptom monitoring and self-management coaching for heart failure patients, not on palliative care as an intervention.
|
OK |
| intervention_education | yes | yes | yes | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study uses the Self-Care of Heart Failure Index (SCHFI) which measures self-care behaviors rather than quality of life, and satisfaction measures which do not qualify as validated QoL instruments.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial uses symptom monitoring and self-management coaching without mention of using a validated Quality of Life instrument like EORTC QLQ-C30 or SF-36.
|
OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost |
yes
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial measures re-hospitalizations as an exploratory clinical outcome, but it does not track healthcare utilization with a cost framing, perform cost analysis, or evaluate economic endpoints.
|
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — While the study tracks hospital readmissions as an exploratory endpoint, it does not frame this in terms of cost-effectiveness, healthcare costs, or economic evaluation - it's measured simply as a clinical outcome.
Thinking: yes — The study measures re-hospitalization rate as an exploratory outcome, and hospital readmissions are considered a cost proxy.
|
yes
yes → yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial evaluates hospital readmissions, which is a proxy for cost.
Thinking: yes — The study measures rehospitalization rates, a healthcare‐utilization outcome that serves as a cost proxy.
|
OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |