Not provided
Not provided
Not provided
Not provided
Not provided
The PI left academic practice
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goals of this work will be to evaluate the preliminary efficacy of a comprehensive pre-dialysis education program on increased knowledge of conservative kidney management and advance care planning among patients with advanced CKD.
This intervention will be randomized among patients with advanced chronic kidney disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard pre-dialysis education | No Intervention | Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation | |
| ESRD education + ACP | Active Comparator | Standard ESRD education + conservative kidney management and advance care planning education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESRD education + conservative kidney management and ACP education | Other | Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention) | Knowledge of conservative kidney management and advance care planning pre-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning | Pre-intervention and Day 1 post-intervention |
| Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention) | Knowledge of conservative kidney management and advance care planning post-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning | Immediate post-intervention |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33619188 | Derived | Stallings TL, Temel JS, Klaiman TA, Paasche-Orlow MK, Alegria M, O'Hare A, O'Connor N, Dember LM, Halpern SD, Eneanya ND. Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. BMJ Open. 2021 Feb 22;11(2):e042620. doi: 10.1136/bmjopen-2020-042620. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Pre-dialysis Education | Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation |
| FG001 | ESRD Education + ACP | Standard ESRD education + conservative kidney management and advance care planning education ESRD education + conservative kidney management and ACP education: Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2024 |
Not provided
Comprehensive pre-dialysis program incorporating conservative and advance care planning education
Not provided
Not provided
Not provided
| COMPLETED |
|
| NOT COMPLETED |
|
All 4 enrolled participants were randomized to the intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Pre-dialysis Education | Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation |
| BG001 | ESRD Education + ACP | Standard ESRD education + conservative kidney management and advance care planning education ESRD education + conservative kidney management and ACP education: Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention) | Knowledge of conservative kidney management and advance care planning pre-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning | No participants were randomized to standard education | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention and Day 1 post-intervention |
|
|
| ||||||||||||||||||||||||||||
| Primary | Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention) | Knowledge of conservative kidney management and advance care planning post-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning | No participants were randomized to standard education. One enrolled participant did not complete the post-knowledge questionnaire | Posted | Mean | Standard Deviation | score on a scale | Immediate post-intervention |
|
|
Through study completion, an average of 1 month
All-Cause Mortality were not monitored/assessed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Pre-dialysis Education | Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | ESRD Education + ACP | Standard ESRD education + conservative kidney management and advance care planning education ESRD education + conservative kidney management and ACP education: Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers | 0 | 0 | 0 | 4 | 0 | 4 |
Not provided
Not provided
This trial was terminated early leading to a small number of participants who where analyzed. Data should be interpreted cautiously given this caveat.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amaka Eneanya | Fresenius Medical Care | 267-769-5455 | amakaeneanya@gmail.com |
| Jan 24, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|