NCT04347759

Symptom Care at Home-Heart Failure: Developing and Piloting a Symptom Monitoring and Self-Management Coaching System for Patients With Heart Failure

Extracted Fields (from Registry)
Protocol IDNCT04347759
Registration Date2020-04-15
Statusrecruiting
SponsorEmory University
CountryUnited States
Industrynot industry
Blindingblinded
Center Typemulticenter RCT
Scopenational RCT
First Patient In2023-02-12
Last Patient Out2026-04-30
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
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
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