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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK125840-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study is a pilot randomized controlled trial testing the effectiveness of integrated ambulatory supportive care visits with standard nephrology outpatient visits for six months in patients with advanced CKD. The study team hypothesizes that patients in the integrated care arm will trend towards improved symptom burden, improved quality of life scores and more engagement in advance care planning.
Primary objectives: To test the impact of integrated ambulatory supportive care in nephrology care on symptom burden. Secondary: To test the impact of integrated ambulatory supportive care on quality of life and engagement in advance care planning and to demonstrate study feasibility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care Intervention | Experimental | The supportive care intervention arm will receive their usual ambulatory longitudinal nephrology care integrated with ambulatory supportive care through monthly supportive care visits over six months. |
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| Usual Care Control | No Intervention | The usual care control arm will be seen at the discretion of their nephrologist, or receive their usual dialysis if on dialysis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory Supportive Care | Other | Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | This will be reported as the percentage of participants who provide informed consent. | Month 12 |
| Number of Participants who Maintain Participation in the Study (Retention) | Reported as percentage of participants who signed informed consent, who completed the study. | Month 12 |
| Average number of clinical visits attended per participant (Retention) | Month 12 | |
| Ability to Collect Planned Data | This will be reported as the percent of completed data surveys | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Kidney Disease Quality of Life (KDQOL-36) Score | The KDQOL is a 36-item quality of life survey that includes five domains: Physical Component Summary (PCS), a Mental Component Summary (MCS), Burden of Kidney Disease Score, Symptoms and Problems of Kidney Disease Score, and Effect of Kidney Disease Score. All scores are on a scale of 0-100, with higher scores representing better quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Scherer, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYC Health + Hospitals / Bellevue | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40008278 | Derived | Scherer JS, Wu W, Lyu C, Goldfeld KS, Brody AA, Chodosh J, Charytan D. A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial. Contemp Clin Trials Commun. 2025 Feb 3;44:101439. doi: 10.1016/j.conctc.2025.101439. eCollection 2025 Apr. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Jennifer.scherer@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2023 | May 23, 2024 | ICF_000.pdf |
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The statistician will be blinded.
| Baseline, Month 6 |
| Engagement in Advance Care Planning | Advance care planning will be measured by total number of advance care planning conversations held. | Baseline, Month 6 |
| Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score | The scoring will include 11 questions on the degree of impact kidney-specific symptoms have had on patients over the past week, plus additional items on concerns beyond symptoms, such as information needs, practical issues, and family anxiety. This includes one question that has 15 sub-questions asking about specific physical symptoms. All scores are on a scale of 0-90, with lower scores representing less problems. | Baseline, Month 6 |