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NCT04164004 · ClinicalTrials.gov registry record · NA
Patient-Reported Outcome Measurement in Heart Failure Clinic
A NA study of Heart Failure, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 1,249
- Enrollment target
- 1
- Study location
NCT04164004: Completed NA study of Heart Failure, sponsored by Stanford University.
NCT04164004 is a NA study of Heart Failure that has completed, run by Stanford University. The registered enrollment target is 1,249 participants, below the 2,046-participant average among 397 other Heart Failure trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04164004, a NA study of Heart Failure, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,249 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. Participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the Kansas City Cardiomyopathy Questionnaire). Participants randomized to early implementation will be given this 12-question survey at each heart failure clinic visit at the beginning of the study; their heart failure clinician will have access to survey results but will continue to manage participants based on standard treatment practice. Patients randomized to delayed implementation will start receiving the survey at each clinic visit one year later. By comparing the health status and treatment rates between early and delayed implementation, this study will determine the impact of standardized health status assessment on patient outcomes and clinician decision-making.
Primary Outcome
The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms. KCCQ-12 scores will be collected in the usual care arm starting one year after randomization. Scores will be adjusted for baseline KCCQ-12 in both arms. This will be the primary effectiveness outcome. KCCQ-12 has 4 domains (Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score) and one Summary Score. Domain scores are scaled 0-100,
Conditions Studied
Interventions
- OTHER Kansas City Cardiomyopathy Questionnaire-12
Study Locations (1)
California
- Stanford Hospital & Clinics - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,249 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2023-11-03 |
| Phase | NA |
What the finished NCT04164004 record still lists
NCT04164004 is an interventional study that assigns participants to a tested intervention. Its 1,249 participants enrollment target places it among the larger protocols in the corpus, below the 2,046-participant average among 397 other Heart Failure trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Kansas City Cardiomyopathy Questionnaire-12 is the first listed.
NCT04164004 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04164004 about?
NCT04164004 is a clinical study titled "Patient-Reported Outcome Measurement in Heart Failure Clinic". This is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. Participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the Kansas...
What is the current status of trial NCT04164004?
This trial is currently completed. It is a NA study. The enrollment target is 1,249 participants. The study started on 2021-08-30. Estimated completion is 2023-11-03.
What conditions does trial NCT04164004 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT04164004?
The interventions under investigation include: Kansas City Cardiomyopathy Questionnaire-12 (OTHER).
Who is sponsoring clinical trial NCT04164004?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04164004 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04164004's enrollment target sits among peer trials
1,249 61st of 397 higher than 337 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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