Weight GainNCT04194164
Development of Fluid Intake App for Management of Fluid Intake During Hemodialysis , Full Scale Trial
A study testing Fluid intake app in people with Weight Gain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Gain
- What is being tested?
- Fluid intake app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study.
- Adult chronic hemodialysis patient who is at least 18 years of age
- Average interdialytic fluid gains of 3.5% or greater of body weight for both weekdays and weekends for a 30 day period
- Availability of interdialytic weight gains for the 2 month period prior to enrollment into the study
- Access to a smartphone for use of the app and comfort with using apps on a regular basis
- Access to a smartphone running under either iOS or Android operating systems
Show all 9Show fewer
- Sufficient knowledge and understanding of the English language to use the application available only in English (US) language
- Mental capacity to use and understand the fluid management app
- Willingness to share intake data collected with the research team
Who cannot join
- Scheduled for a living related renal transplant in the next seven months
- Hospitalization within 30 days of entry into the study
- Current participation in a randomized clinical trial or in the exclusion period of another clinical trial
- Vulnerable subjects defined as individuals whose willingness to volunteer in the clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Fluid Intake App for Management of Volume Intake in Patients Receiving Chronic Hemodialysis Therapy, Full Scale Trial
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. NCT 03759847 was designed to test the safety and efficacy of this app. In this protocol, part of the same IRB number, patients with large interdialytic fluid gains (3.5% or greater) 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.
Read the detailed description
In this full scale study, the app will be used to try and influence fluid intake behavior in those patients who are identified to have large fluid weight gains, as defined by a greater than 4% increase in interdialytic weight.
There will be two parts to the full scale trial. In the first part of the full scale study, denoted as the active phase, which will last for two months, study participants will be encouraged to use the app on a daily basis and will meet with the study coordinator on weeks 1, 2, 4, 6, and 8 to further assist the participant in decreasing fluid intake between dialysis sessions. In the second portion of the study, denoted as the passive phase, which will last for six months, the patient will use the app and meet with the study coordinator only when requested by the patient. The number of these sessions will be recorded. At the end of the six month passive phase, the participant will meet for the last time with the study coordinator. During each study visit, subjects will be asked to transfer the data from the App to the study coordinator via the data export function of the app.
- Conditions
- Weight Gain
- Being tested
- Fluid intake app
- Keywords
- Hemodialysis, End stage renal disease on dialysis, Fluid intake, Interdialytic weight gain
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid intake appOther
Monitor fluid intake and interdialytic weight gain in patients using the fluid app
| Study group | Role | What they receive |
|---|---|---|
| Fluid intake app | Experimental | Participants in this arm will use the fluid intake app to help them decrease interdialytic fluid intake. Participants will take a survey to assess the efficacy of the fluid app.. Receives: Other: Fluid intake app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intradialytic weight gain
Comparison of interdialytic weight change before and during use of the app
Measured: between baseline (pre-app) and the Active phase (months 1 and 2)
Mean intradialytic weight gain
Comparison of interdialytic weight change before and during use of the app
Measured: between baseline (pre-app) and the Passive phase (month 3-8)
Secondary outcomes (6)
Mean intradialytic weight gain
Measured: between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
25th percentile of intradialytic weight gain
Measured: between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
75th percentile of intradialytic weight gain
Measured: between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
Number of days of app usage
Measured: the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
Percentage of days of app usage
Measured: the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
Number of patients who experienced at least 50% increase in fluid intake during app use
Safety evaluation.
Measured: the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start2 Dec 2019
- Primary completion11 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparison of interdialytic weight gain with fluid intake as recorded by fluid app
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Sponsor
- Investigators
- Michael Rocco, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194164
- Sponsor's protocol ID
- IRB00048561a
- Status last verified
- Sep 2021
- First submitted
- 9 Dec 2019
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 264984162. United States Renal Data System 2018. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD
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.
PubMed 12490682FHN 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.
PubMed 21091062Chan 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.
PubMed 22360996Chan 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.
PubMed 23970131Assimon 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.
PubMed 27575009
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Intake App for Management of Volume Intake in Patients Receiving Chronic Hemodialysis Therapy, Full Scale Trial
- ClinicalTrials.gov ID
- NCT04194164
- Acronym / sponsor ID
- IRB00048561a
- Conditions
- Weight Gain
- Keywords
- Hemodialysis, End stage renal disease on dialysis, Fluid intake, Interdialytic weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. NCT 03759847 was designed to test the safety and efficacy of this app. In this protocol, part of the same IRB number, patients with large interdialytic fluid gains (3.5% or greater) 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.
Detailed description
In this full scale study, the app will be used to try and influence fluid intake behavior in those patients who are identified to have large fluid weight gains, as defined by a greater than 4% increase in interdialytic weight.
There will be two parts to the full scale trial. In the first part of the full scale study, denoted as the active phase, which will last for two months, study participants will be encouraged to use the app on a daily basis and will meet with the study coordinator on weeks 1, 2, 4, 6, and 8 to further assist the participant in decreasing fluid intake between dialysis sessions. In the second portion of the study, denoted as the passive phase, which will last for six months, the patient will use the app and meet with the study coordinator only when requested by the patient. The number of these sessions will be recorded. At the end of the six month passive phase, the participant will meet for the last time with the study coordinator. During each study visit, subjects will be asked to transfer the data from the App to the study coordinator via the data export function of the app.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparison of interdialytic weight gain with fluid intake as recorded by fluid app
| Arm | Type | Receives |
|---|---|---|
| Fluid intake app | Experimental | Other: Fluid intake appParticipants in this arm will use the fluid intake app to help them decrease interdialytic fluid intake. Participants will take a survey to assess the efficacy of the fluid app.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study.
- Adult chronic hemodialysis patient who is at least 18 years of age
- Average interdialytic fluid gains of 3.5% or greater of body weight for both weekdays and weekends for a 30 day period
- Availability of interdialytic weight gains for the 2 month period prior to enrollment into the study
- Access to a smartphone for use of the app and comfort with using apps on a regular basis
Key exclusion criteria (4 listed)
- Scheduled for a living related renal transplant in the next seven months
- Hospitalization within 30 days of entry into the study
- Current participation in a randomized clinical trial or in the exclusion period of another clinical trial
- Vulnerable subjects defined as individuals whose willingness to volunteer in the clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid intake appMonitor fluid intake and interdialytic weight gain in patients using the fluid app | Other | Fluid intake app |
Primary outcome
Mean intradialytic weight gain
Time frame: between baseline (pre-app) and the Active phase (months 1 and 2)
Comparison of interdialytic weight change before and during use of the app
Mean intradialytic weight gain
Time frame: between baseline (pre-app) and the Passive phase (month 3-8)
Comparison of interdialytic weight change before and during use of the app
6 secondary outcomes
Mean intradialytic weight gain
Time frame: between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
25th percentile of intradialytic weight gain
Time frame: between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
75th percentile of intradialytic weight gain
Time frame: between baseline (pre-app) and the Active phase (months 1 and 2), between baseline (pre-app) and the Passive phase (month 3-8)
Number of days of app usage
Time frame: the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
Percentage of days of app usage
Time frame: the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
Number of patients who experienced at least 50% increase in fluid intake during app use
Time frame: the Active phase (months 1 and 2), Passive phase (month 3 through month 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Background: PubMed 26498416National 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.
- Background2. United States Renal Data System 2018. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD
- Background: PubMed 12490682Eknoyan 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.
- Background: PubMed 21091062FHN 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.
- Background: PubMed 22360996Chan 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.
- Background: PubMed 23970131Chan 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.
- Background: PubMed 27575009Assimon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Rocco, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid intake app in people with Weight Gain, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean intradialytic weight gain (time frame: between baseline (pre-app) and the Active phase (months 1 and 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194164, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.