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| Name | Class |
|---|---|
| Danone Global Research & Innovation Center | INDUSTRY |
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Methods are needed to help decrease interdialytic weight gains in hemodialysis patients. One potential method for accomplishing this goal is to develop an app for smartphones that allow patients to track their fluid intake throughout the course of the day. This protocol is designed to test the safety and efficacy of this app, followed by use of the app in patients with large fluid weight gains between HD sessions. In the Vanguard phase, patients without large interdialytic fluid gains (less than 4%) will use the app to to determine the association between the interdialytic weight gain and the fluid consumed as recorded by use of the app for each interdialytic period. The app will be modified, if needed, prior to initiation of the full scale trial.
For the Vanguard phase of the trial, a survey will be used to assess the usability of the app as well as to collect recommendations for changes to the app itself (appendix one). For this Vanguard phase study, the survey for participants will be designed to assess the usability of the app (ease of use in general, ease of capturing fluid intake data, including the choice of preselected volumes for fluid containers, reasons for not using the app more frequently, the usefulness of the app notifications, ease of sending data to the study coordinator for review). The survey for the study coordinator will be designed to assess the ease of reviewing data from participants and the perceived difficulty of patient use of the app.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanguard | Experimental | Participants in this arm will use the fluid intake app and take a survey to test the fluid intake monitoring app for both safety and design issues. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid intake app | Other | Use of fluid app to monitor intake of fluids |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of interdialytic weight gain | The amount of weight gain as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix. | 1 month |
| Amount of fluid consumed | The fluid consumed as recorded by use of the app for each interdialytic period. The association between the interdialytic weight gain and the fluid consumed will be assessed by a repeated measures analysis of variance with an unstructured covariance matrix. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who experienced a 50% increase in fluid intake during app use | This will be a safety evaluation to ensure that no participants had more than a 50% increase in fluid intake while using the app. It will be described using descriptive statistics. | 1 month |
| Number of days that the app was used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Rocco, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26498416 | Background | National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015. | |
| Background | United States Renal Data System. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD | ||
| 12490682 |
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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 | Nov 11, 2020 | Jan 5, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Comparison of interdialytic weight gain with fluid intake as recorded by fluid app
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| Survey |
| Other |
A survey will be used to assess the usability of the app (ease of use in general, ease of capturing fluid intake data, including the choice of pre-selected volumes for fluid containers, reasons for not using the app more frequently, the usefulness of the app notifications, ease of sending data to the study coordinator for review) as well as to collect recommendations for changes to the app itself. |
|
This will be the determination of the number of days that the app was used. |
| 1 month |
| Number of days that the app was used by day of the week | Differences in app use by specific days of the week. This is a sub analysis using days of the week. | 1 month |
| Number of days that the app was used by dialysis or non-dialysis days | Differences in app use by specific days of the week, including dialysis and non-dialysis days. This is a sub analysis using dialysis versus non-dialysis days. | 1 month |
| Ratio of weight of liquid intake | Agreement between fluid intake and weight gain will be described using descriptive statistics by the ratio of weight of liquid intake between two visits over the interdialytic weight gain | 1 month |
| Background |
| Eknoyan G, Beck GJ, Cheung AK, Daugirdas JT, Greene T, Kusek JW, Allon M, Bailey J, Delmez JA, Depner TA, Dwyer JT, Levey AS, Levin NW, Milford E, Ornt DB, Rocco MV, Schulman G, Schwab SJ, Teehan BP, Toto R; Hemodialysis (HEMO) Study Group. Effect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med. 2002 Dec 19;347(25):2010-9. doi: 10.1056/NEJMoa021583. |
| 21091062 | Background | FHN Trial Group; Chertow GM, Levin NW, Beck GJ, Depner TA, Eggers PW, Gassman JJ, Gorodetskaya I, Greene T, James S, Larive B, Lindsay RM, Mehta RL, Miller B, Ornt DB, Rajagopalan S, Rastogi A, Rocco MV, Schiller B, Sergeyeva O, Schulman G, Ting GO, Unruh ML, Star RA, Kliger AS. In-center hemodialysis six times per week versus three times per week. N Engl J Med. 2010 Dec 9;363(24):2287-300. doi: 10.1056/NEJMoa1001593. Epub 2010 Nov 20. |
| 22360996 | Background | Chan CT, Greene T, Chertow GM, Kliger AS, Stokes JB, Beck GJ, Daugirdas JT, Kotanko P, Larive B, Levin NW, Mehta RL, Rocco M, Sanz J, Schiller BM, Yang PC, Rajagopalan S; Frequent Hemodialysis Network (FHN) Trial Group. Determinants of left ventricular mass in patients on hemodialysis: Frequent Hemodialysis Network (FHN) Trials. Circ Cardiovasc Imaging. 2012 Mar;5(2):251-61. doi: 10.1161/CIRCIMAGING.111.969923. Epub 2012 Feb 23. |
| 23970131 | Background | Chan CT, Greene T, Chertow GM, Kliger AS, Stokes JB, Beck GJ, Daugirdas JT, Kotanko P, Larive B, Levin NW, Mehta RL, Rocco M, Sanz J, Yang PC, Rajagopalan S; Frequent Hemodialysis Network Trial Group. Effects of frequent hemodialysis on ventricular volumes and left ventricular remodeling. Clin J Am Soc Nephrol. 2013 Dec;8(12):2106-16. doi: 10.2215/CJN.03280313. Epub 2013 Aug 22. |
| 27575009 | Background | Assimon MM, Wenger JB, Wang L, Flythe JE. Ultrafiltration Rate and Mortality in Maintenance Hemodialysis Patients. Am J Kidney Dis. 2016 Dec;68(6):911-922. doi: 10.1053/j.ajkd.2016.06.020. Epub 2016 Aug 26. |
| 37663954 | Derived | Rocco MV, Rigaud M, Ertel C, Russell G, Zemdegs J, Vecchio M. Fluid Intake Management in Maintenance Hemodialysis Using a Smartphone-Based Application: A Pilot Study. Kidney Med. 2023 Jul 26;5(9):100703. doi: 10.1016/j.xkme.2023.100703. eCollection 2023 Sep. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |