An interventional study of Educational video and/or handout in Heart Failure, Systolic and Heart Failure, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-08.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
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Among 83 studies in Heart Failure, Systolic with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Heart Failure, Systolic · United States.
Among the 83 studies in Heart Failure, Systolic with a site in United States, this one is the 3rd largest by enrollment of the 69 interventional ones that give a count, is one of 10 that started in 2018, is one of 44 with no phase, and was the 29th registered.
230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.
Browse Heart Failure, Systolic studies →17 of the 83 studies in Heart Failure, Systolic with a site in United States are open now. Recruiting first, the newest first:
Abiomed Inc. · Sites in United States
Ages 18–80
Eli Lilly and Company · Sites in United States, Japan, Moldova and 2 more countries
Ages 18–65
Kaiser Permanente · Sites in United States
Ages 18+
Impulse Dynamics · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Heart Failure, Systolic studies recruiting now, 19 (66%) set no upper age limit and 2 (7%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 10 · Phase 3 2 · Phase 4 8
First in 2005; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 790 is above the median of 60 across 165 interventional studies indexed under Heart Failure, Systolic.
Median enrollment 40 across the 69 interventional studies, 148 across the 14 observational. Of the 48 that completed or were terminated, 17 (35%) have results posted.
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24 of 83 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 4 studies filed under Heart Failure, Systolic — fewer than ten, so there is no comparison to draw.
7 of the studies in Heart Failure, Systolic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925608BioCardia, Inc.Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells | 2026-12 |
| NCT06009276University of VirginiaAssociations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status | 2026-12 |
| NCT06671015Yale UniversityA Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure | 2027-01 |
| NCT07252310Weill Medical College of Cornell UniversityPilot Study of StudyU for N-of-1 Trials in HFrEF Patients (N-of-1 App) | 2027-02 |
| NCT05230732University of OklahomaNeuromodulation of Inflammation and Endothelial Function | 2027-02-27 |
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Among the 83 studies in Heart Failure, Systolic with a site in United States, from their registry updates:
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The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.
The investigators propose the DECIDE-ICD trial: a type II effectiveness implementation hybrid trial of the investigators ICD PtDAs. The Investigators will use a 6-site stepped-wedge design, with implementation guided by normalization process theory® and evaluation guided by the RE-AIM framework.
The investigators aim to evaluate reach and effectiveness of the ICD PtDAs using a pragmatic, stepped-wedge design on decision quality (knowledge and value-concordance) and psychosocial outcomes.
The investigators propose 3 a priori hypotheses:
Along with these hypotheses, we recognize that other important covariates exist, such as health literacy and education level.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
These participants will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
These participants will receive an educational video and/or handout about the defibrillator process. Then they will fill out surveys in regard to their experiences, opinions, and knowledge of the defibrillator process.
Other: Educational video and/or handout
The intervention includes a video and/or handout (whichever is easier for the participant) that will give information about defibrillators and about other patients' experiences with their decisions about defibrillators.
Knowledge About Defibrillation at Baseline
Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
Time frame: Baseline
Knowledge About Defibrillation at 1 Month
Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
Time frame: 1 month
Knowledge About Defibrillation at 6 Months
Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
Time frame: 6 months
Reach of Eligible Patients
Measuring how many patients of the eligible patient base are able to view or read the educational materials.
Time frame: Baseline
Differential Effect by Age
The decision aids will have a differential effect on the decisions of participants by age (\>= 70 years old vs \<70 years old)
Time frame: Baseline, 1 month, 6 months
Differential Effect by Heart Failure Type
The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
Time frame: Baseline, 1 month, 6 months
Differential Effect by Type of Device
The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).
Time frame: Baseline, 1 month, 6 months
| Milestone | Surveys Only | Educational Video and/or Handout + Surveys |
|---|---|---|
| Started | 346 | 444 |
| Completed | 323 | 437 |
| Not completed | 23 | 7 |
Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
| score on a scale | Surveys Only | Educational Video and/or Handout + Surveys |
|---|---|---|
| Knowledge About Defibrillation at Baseline | 53.4 ± 17.6 | 55.4 ± 17.0 |
Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
| score on a scale | Surveys Only | Educational Video and/or Handout + Surveys |
|---|---|---|
| Knowledge About Defibrillation at 1 Month | 57.1 ± 18.2 | 58.0 ± 15.4 |
Multiple survey responses by participants will indicate knowledge changes over time. The Decision Quality Knowledge Survey measures knowledge about defibrillators. Possible scores range from 0 to 100, with higher scores indicating more knowledge and better outcomes.
| score on a scale | Surveys Only | Educational Video and/or Handout + Surveys |
|---|---|---|
| Knowledge About Defibrillation at 6 Months | 56.6 ± 17.4 | 58.6 ± 14.5 |
Measuring how many patients of the eligible patient base are able to view or read the educational materials.
| Participants | Surveys Only | Educational Video and/or Handout + Surveys |
|---|---|---|
| Were administered intervention by hospital | — | 349 |
| Were not administered intervention by hospital | — | 88 |
The decision aids will have a differential effect on the decisions of participants by age (\>= 70 years old vs \<70 years old)
Results for this outcome have not been posted.
The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic)
Results for this outcome have not been posted.
The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).
Results for this outcome have not been posted.
Collected over 6 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Surveys Only | — | — | 3/346 (0.9%) |
| Educational Video and/or Handout + Surveys | — | — | 0/444 (0%) |
| Event | Surveys Only | Educational Video and/or Handout + Surveys |
|---|---|---|
| Incomplete consent processInvestigations | 3/9 | 0/51 |
Baseline characteristics were only collected for participants who completed the study.
| Age, Continuous(years) | Surveys Only | Educational Video and/or Handout + Surveys | Total |
|---|---|---|---|
| Mean | 66 (56 to 73) | 67 (58 to 74) | 66.5 (56 to 74) |
| Sex: Female, Male(Participants) | Surveys Only | Educational Video and/or Handout + Surveys | Total |
|---|---|---|---|
| Female | 89 | 120 | 209 |
| Male | 234 | 317 | 551 |
| Ethnicity (NIH/OMB)(Participants) | Surveys Only | Educational Video and/or Handout + Surveys | Total |
|---|---|---|---|
| Hispanic or Latino | 24 | 18 | 42 |
| Not Hispanic or Latino | 299 | 419 | 718 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Surveys Only | Educational Video and/or Handout + Surveys | Total |
|---|---|---|---|
| American Indian or Alaska Native | 8 | 5 | 13 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 37 | 47 | 84 |
| White | 250 | 339 | 589 |
| More than one race | 10 | 16 | 26 |
| Unknown or Not Reported | 16 | 28 | 44 |
| Region of Enrollment(participants) | Surveys Only | Educational Video and/or Handout + Surveys | Total |
|---|---|---|---|
| United States | 323 | 437 | 760 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Dec 2021, 43 months.
Results were first posted in Jul 2022, 6 months after primary completion.
Of 52 non-industry interventional studies with no phase under Heart Failure, Systolic, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's 43 months is above that.
Counting every sponsor, half of 56 studies reached it within 30 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →