Kidney TransplantTASKNCT05151445
The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients
An observational study of Kidney Transplant and Kidney Transplant; Complications, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of the study is to test the feasibility mHealth dietary app + health coaching for improving primary outcomes (recruitment, retention, and adherence) and secondary outcomes (perceived stress [ Perceived Stress Scale], exercise self-efficacy[Exercise Self-efficacy Scale], vegetable intake [Fruit, Vegetables… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Kidney Transplant; Complications
- What is being tested?
- mHealth dietary app + health coaching intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The participants will be recruited or contacted from a list of kidney recipients that have already requested they be contacted for future studies from our previous study. This list consists of approximately 60 people.
Who may be able to join
- age 18 or older men and women
- functioning KTR (not on dialysis)
- ability to speak, read, and hear English,
- possession of a smartphone capable of accessing and downloading a mHealth dietary app
- Wi-Fi or Internet access,
- greater than 3 months post-transplant (due to medication adjustments and decreased functional levels),
- not hospitalized
- capable of self-consent per capacity screening.
Who cannot join
- Participation in a weight loss program
- participation in a structured exercise program
- diagnosis of dementia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
The purpose of the study is to test the feasibility mHealth dietary app + health coaching for improving primary outcomes (recruitment, retention, and adherence) and secondary outcomes (perceived stress [ Perceived Stress Scale], exercise self-efficacy[Exercise Self-efficacy Scale], vegetable intake [Fruit, Vegetables, and Fiber Screen] fat intake [Lose-it Premium database], carbohydrate intake [Lose-it Premium database], weight, [Wi-Fi weight scale using the Lose-it Premium database], and blood pressure [Wi-Fi blood pressure cuff using the Lose-it Premium database].
Read the detailed description
The proposed study seeks to shift the paradigm for promoting diet intake and physical activity using education and self-report to provide a powerful combination of mHealth dietary app and health coaching (set goals, provide ongoing feedback, and self-monitor behaviors). To the investigators knowledge, this is the first time a mHealth dietary app and health coaching intervention has been used in kidney transplant recipients to link real-time data for monitoring dietary intake and physical activity.
The long-term goal of this work is to enhance well-being in kidney recipients via lifestyle self-management of care for dietary intake and physical activity to ultimately prevent chronic diseases. The proposed study is important because early weight gain after kidney transplant is associated with adverse effects on the transplanted kidney function resulting in increased health care cost and poor quality of life. Interventions are needed to monitor kidney transplant recipients diet and physical activity in real-time to prevent health decline.
- Being tested
- mHealth dietary app + health coaching intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth dietary app + health coaching interventionBehavioural
The "Lose-It" app will be set up with Gmail accounts with unique unidentifiable codes developed by the research team. Participants be trained to enter their dietary intake and physical activity daily for 12-weeks. Participants will monitor their vegetable intake, fat intake, carbohydrate intake, weight, and blood pressure. Wi-Fi connected weight scales and blood pressure cuff will be supplied for weight and blood pressure monitoring. Participants will be taught how to sync the data from the scales and blood pressure cuff to the app for the research team to access. Participants will perform a return demonstration to confirm that they can record their dietary intake daily, physical activity, weight, and blood pressure using the "Lose-It" app. We also review with the participant the "My Plate" method for proper nutrition and the steps to distance conversion chart.
| Study group | Role | What they receive |
|---|---|---|
| mHealth dietary app + health coaching intervention | A feasibility study will be utilized to establish the recruitment, retention, and adherence with post-kidney transplant recipients using a consumer-based mHealth dietary app + health coaching. Receives: Behavioral: mHealth dietary app + health coaching intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Feasibility of the Study Recruitment for the Study
Recruitment (percent of participants approached to be in the study), will be recorded by the research assistant.
Measured: Baseline
The Feasibility of Participant Retention for the Study
Retention (percent of participants that dropped during the study), will be recorded by the research assistant.
Measured: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Adherence (percent to adhere to logging daily dietary intake) will be recorded continuously each day by the "Lose-It" app.
Measured: Weekly for 12 weeks
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Adherence (percent to adhere to logging daily physical activity) will be recorded continuously each day by the "Lose-It" app.
Measured: Weekly for 12 weeks
Secondary outcomes (9)
Perceived Stress Level
Perceived Stress Scale will be evaluated by using the Perceived Stress Scale (PSS).The PSS is a 10-item questionnaire using a Likert Scale to rate feelings of stress from 0 "never" to 4 "very often." Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Exercise Self-Efficacy
Exercise Self-Efficacy Scale will be evaluated by using the Self-Efficacy for Exercise (SEE) Scale. The SEE is a 9-item questionnaire using a Likert Scale to rate feelings of stress from 0 "not confident" to 10 "very confident." This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Measured: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Fruit and Vegetable Servings Per Day
Fruit and vegetable intake will be assessed using the Fruit, Vegetable and Fiber Screen which uses a scale to assess fruit and vegetable intake using a Likert Scale to rate intake from less than1/ per week to more than 2 a day. Higher scores indicate that more fruits and vegetables are being consumed by participants.
Measured: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Fiber Intake
Fiber intake will be assessed using the Fruit, Vegetable and Fiber Screen which uses a scale to assessfiber intake using a Likert Scale to rate intake from less than1/ per week to more than 2 a day.Higher scores indicate more fiber intake.
Measured: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Fat Intake
The participant will record their percent of fat intake each day into the Lose-it Premium application.
Measured: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Carbohydrate Intake
The participant will record their percent of carbohydrate intake each day into the Lose-it Premium application.
Measured: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Weight
Weight (pounds) will be measured each day by the participant using a wireless Wi Fi weight scale. The data from the wireless weight scale will sync the data from the participant's mobile phone to the premium password-protect "Lose-It" database each day.
Measured: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Systolic Blood Pressure
Systolic blood pressure (millimeters of mercury [mmHg]) will be recorded each day by the participant using a wireless Wi Fi blood pressure cuff. The data from the wireless cuff will sync from the participant's mobile phone to the premium password-protect "Lose-It" database each day.
Measured: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Diastolic Blood Pressure
Systolic blood pressure (millimeters of mercury [mmHg]) will be recorded each day by the participant using a wireless Wi Fi blood pressure cuff. The data from the wireless cuff will sync from the participant's mobile phone to the premium password-protect "Lose-It" database each day.
Measured: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Mar 2021
- Primary completion1 Jan 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tara O'Brien, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151445
- Sponsor's protocol ID
- 2020B0261
- Acronym
- TASK
- Status last verified
- Aug 2024
- First submitted
- 9 Nov 2021
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conte C, Secchi A. Post-transplantation diabetes in kidney transplant recipients: an update on management and prevention. Acta Diabetol. 2018 Aug;55(8):763-779. doi: 10.1007/s00592-018-1137-8. Epub 2018 Apr 4.
PubMed 29619563Aksoy N. Weight Gain After Kidney Transplant. Exp Clin Transplant. 2016 Nov;14(Suppl 3):138-140.
PubMed 27805534Zelle DM, Kok T, Dontje ML, Danchell EI, Navis G, van Son WJ, Bakker SJ, Corpeleijn E. The role of diet and physical activity in post-transplant weight gain after renal transplantation. Clin Transplant. 2013 Jul-Aug;27(4):E484-90. doi: 10.1111/ctr.12149. Epub 2013 Jun 13.
PubMed 23758229Workeneh B, Moore LW, Nolte Fong JV, Shypailo R, Gaber AO, Mitch WE. Successful Kidney Transplantation Is Associated With Weight Gain From Truncal Obesity and Insulin Resistance. J Ren Nutr. 2019 Nov;29(6):548-555. doi: 10.1053/j.jrn.2019.01.009. Epub 2019 Mar 7.
PubMed 30852120Rosenberger J, Geckova AM, Dijk JP, Roland R, Heuvel WJ, Groothof F JW. Factors modifying stress from adverse effects of immunosuppressive medication in kidney transplant recipients. Clin Transplant. 2005 Feb;19(1):70-6. doi: 10.1111/j.1399-0012.2004.00300.x.
PubMed 15659137Klaassen G, Zelle DM, Navis GJ, Dijkema D, Bemelman FJ, Bakker SJL, Corpeleijn E. Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: Design of the Active Care after Transplantation (ACT) randomized controlled trial. BMC Nephrol. 2017 Sep 15;18(1):296. doi: 10.1186/s12882-017-0709-0.
PubMed 28915863Kim IK, Choi SH, Son S, Ju MK. Early Weight Gain After Transplantation Can Cause Adverse Effect on Transplant Kidney Function. Transplant Proc. 2016 Apr;48(3):893-6. doi: 10.1016/j.transproceed.2015.10.064.
PubMed 27234761Edwards ES, Sackett SC. Psychosocial Variables Related to Why Women are Less Active than Men and Related Health Implications. Clin Med Insights Womens Health. 2016 Jul 4;9(Suppl 1):47-56. doi: 10.4137/CMWH.S34668. eCollection 2016.
PubMed 27398045Hap K, Madziarska K, Hap W, Zmonarski S, Zielinska D, Kaminska D, Banasik M, Koscielska-Kasprzak K, Klinger M, Mazanowska O. Are Females More Prone Than Males to Become Obese After Kidney Transplantation? Ann Transplant. 2019 Jan 29;24:57-61. doi: 10.12659/AOT.912096.
PubMed 30737367Pedrollo EF, Nicoletto BB, Carpes LS, de Freitas JMC, Buboltz JR, Forte CC, Bauer AC, Manfro RC, Souza GC, Leitao CB. Effect of an intensive nutrition intervention of a high protein and low glycemic-index diet on weight of kidney transplant recipients: study protocol for a randomized clinical trial. Trials. 2017 Sep 6;18(1):413. doi: 10.1186/s13063-017-2158-2.
PubMed 28874181Wilcox J, Waite C, Tomlinson L, Driscoll J, Karim A, Day E, Sharif A. Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial. Trials. 2016 Aug 22;17(1):417. doi: 10.1186/s13063-016-1543-6.
PubMed 27550305Clunk JM, Lin CY, Curtis JJ. Variables affecting weight gain in renal transplant recipients. Am J Kidney Dis. 2001 Aug;38(2):349-53. doi: 10.1053/ajkd.2001.26100.
PubMed 11479161Aminu MS, Sagren N, Manga P, Nazir MS, Naicker S. Obesity and graft dysfunction among kidney transplant recipients: Increased risk for atherosclerosis. Indian J Nephrol. 2015 Nov-Dec;25(6):340-3. doi: 10.4103/0971-4065.151358.
PubMed 26664208Williams-Hooker R, Draper CM, Chen L, Mitchell CO, Cashion AK. The relationship between fruit and vegetable consumption and weight gain in kidney transplant recipients within 1 year posttransplant. Top Clin Nutr. 2015;30(4):324-332.
Mellen PB, Gao SK, Vitolins MZ, Goff DC Jr. Deteriorating dietary habits among adults with hypertension: DASH dietary accordance, NHANES 1988-1994 and 1999-2004. Arch Intern Med. 2008 Feb 11;168(3):308-14. doi: 10.1001/archinternmed.2007.119.
PubMed 18268173
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT05151445
- Acronym / sponsor ID
- TASK / 2020B0261
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test the feasibility mHealth dietary app + health coaching for improving primary outcomes (recruitment, retention, and adherence) and secondary outcomes (perceived stress [ Perceived Stress Scale], exercise self-efficacy[Exercise Self-efficacy Scale], vegetable intake [Fruit, Vegetables, and Fiber Screen] fat intake [Lose-it Premium database], carbohydrate intake [Lose-it Premium database], weight, [Wi-Fi weight scale using the Lose-it Premium database], and blood pressure [Wi-Fi blood pressure cuff using the Lose-it Premium database].
Detailed description
The proposed study seeks to shift the paradigm for promoting diet intake and physical activity using education and self-report to provide a powerful combination of mHealth dietary app and health coaching (set goals, provide ongoing feedback, and self-monitor behaviors). To the investigators knowledge, this is the first time a mHealth dietary app and health coaching intervention has been used in kidney transplant recipients to link real-time data for monitoring dietary intake and physical activity.
The long-term goal of this work is to enhance well-being in kidney recipients via lifestyle self-management of care for dietary intake and physical activity to ultimately prevent chronic diseases. The proposed study is important because early weight gain after kidney transplant is associated with adverse effects on the transplanted kidney function resulting in increased health care cost and poor quality of life. Interventions are needed to monitor kidney transplant recipients diet and physical activity in real-time to prevent health decline.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mHealth dietary app + health coaching intervention | – | Behavioral: mHealth dietary app + health coaching interventionA feasibility study will be utilized to establish the recruitment, retention, and adherence with post-kidney transplant recipients using a consumer-based mHealth dietary app + health coaching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be recruited or contacted from a list of kidney recipients that have already requested they be contacted for future studies from our previous study. This list consists of approximately 60 people.
Key inclusion criteria (8 listed)
- age 18 or older men and women
- functioning KTR (not on dialysis)
- ability to speak, read, and hear English,
- possession of a smartphone capable of accessing and downloading a mHealth dietary app
- Wi-Fi or Internet access,
Key exclusion criteria (3 listed)
- Participation in a weight loss program
- participation in a structured exercise program
- diagnosis of dementia.
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 |
|---|---|---|
| mHealth dietary app + health coaching interventionThe "Lose-It" app will be set up with Gmail accounts with unique unidentifiable codes developed by the research team. Participants be trained to enter their dietary intake and physical activity daily for 12-weeks. Participants will monitor their vegetable intake, fat intake, carbohydrate intake, weight, and blood pressure. Wi-Fi connected weight scales and blood pressure cuff will be supplied for weight and blood pressure monitoring. Participants will be taught how to sync the data from the scales and blood pressure cuff to the app for the research team to access. Participants will perform a return demonstration to confirm that they can record their dietary intake daily, physical activity, weight, and blood pressure using the "Lose-It" app. We also review with the participant the "My Plate" method for proper nutrition and the steps to distance conversion chart. | Behavioural | mHealth dietary app + health coaching intervention |
Primary outcome
The Feasibility of the Study Recruitment for the Study
Time frame: Baseline
Recruitment (percent of participants approached to be in the study), will be recorded by the research assistant.
The Feasibility of Participant Retention for the Study
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Retention (percent of participants that dropped during the study), will be recorded by the research assistant.
The Feasibility of Adherence for Using the Lose- It App to Record Diet
Time frame: Weekly for 12 weeks
Adherence (percent to adhere to logging daily dietary intake) will be recorded continuously each day by the "Lose-It" app.
The Feasibility of Adherence for Using the Lose- It App to Physical Actvity
Time frame: Weekly for 12 weeks
Adherence (percent to adhere to logging daily physical activity) will be recorded continuously each day by the "Lose-It" app.
9 secondary outcomes
Perceived Stress Level
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Exercise Self-Efficacy
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Fruit and Vegetable Servings Per Day
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Fiber Intake
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Fat Intake
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Carbohydrate Intake
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Weight
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Systolic Blood Pressure
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Diastolic Blood Pressure
Time frame: Assessed at Baseline, 4 weeks, 8 weeks, and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29619563Conte C, Secchi A. Post-transplantation diabetes in kidney transplant recipients: an update on management and prevention. Acta Diabetol. 2018 Aug;55(8):763-779. doi: 10.1007/s00592-018-1137-8. Epub 2018 Apr 4.
- Background: PubMed 27805534Aksoy N. Weight Gain After Kidney Transplant. Exp Clin Transplant. 2016 Nov;14(Suppl 3):138-140.
- Background: PubMed 23758229Zelle DM, Kok T, Dontje ML, Danchell EI, Navis G, van Son WJ, Bakker SJ, Corpeleijn E. The role of diet and physical activity in post-transplant weight gain after renal transplantation. Clin Transplant. 2013 Jul-Aug;27(4):E484-90. doi: 10.1111/ctr.12149. Epub 2013 Jun 13.
- Background: PubMed 30852120Workeneh B, Moore LW, Nolte Fong JV, Shypailo R, Gaber AO, Mitch WE. Successful Kidney Transplantation Is Associated With Weight Gain From Truncal Obesity and Insulin Resistance. J Ren Nutr. 2019 Nov;29(6):548-555. doi: 10.1053/j.jrn.2019.01.009. Epub 2019 Mar 7.
- Background: PubMed 15659137Rosenberger J, Geckova AM, Dijk JP, Roland R, Heuvel WJ, Groothof F JW. Factors modifying stress from adverse effects of immunosuppressive medication in kidney transplant recipients. Clin Transplant. 2005 Feb;19(1):70-6. doi: 10.1111/j.1399-0012.2004.00300.x.
- Background: PubMed 28915863Klaassen G, Zelle DM, Navis GJ, Dijkema D, Bemelman FJ, Bakker SJL, Corpeleijn E. Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: Design of the Active Care after Transplantation (ACT) randomized controlled trial. BMC Nephrol. 2017 Sep 15;18(1):296. doi: 10.1186/s12882-017-0709-0.
- Background: PubMed 27234761Kim IK, Choi SH, Son S, Ju MK. Early Weight Gain After Transplantation Can Cause Adverse Effect on Transplant Kidney Function. Transplant Proc. 2016 Apr;48(3):893-6. doi: 10.1016/j.transproceed.2015.10.064.
- Background: PubMed 27398045Edwards ES, Sackett SC. Psychosocial Variables Related to Why Women are Less Active than Men and Related Health Implications. Clin Med Insights Womens Health. 2016 Jul 4;9(Suppl 1):47-56. doi: 10.4137/CMWH.S34668. eCollection 2016.
- Background: PubMed 30737367Hap K, Madziarska K, Hap W, Zmonarski S, Zielinska D, Kaminska D, Banasik M, Koscielska-Kasprzak K, Klinger M, Mazanowska O. Are Females More Prone Than Males to Become Obese After Kidney Transplantation? Ann Transplant. 2019 Jan 29;24:57-61. doi: 10.12659/AOT.912096.
- Background: PubMed 28874181Pedrollo EF, Nicoletto BB, Carpes LS, de Freitas JMC, Buboltz JR, Forte CC, Bauer AC, Manfro RC, Souza GC, Leitao CB. Effect of an intensive nutrition intervention of a high protein and low glycemic-index diet on weight of kidney transplant recipients: study protocol for a randomized clinical trial. Trials. 2017 Sep 6;18(1):413. doi: 10.1186/s13063-017-2158-2.
- Background: PubMed 27550305Wilcox J, Waite C, Tomlinson L, Driscoll J, Karim A, Day E, Sharif A. Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial. Trials. 2016 Aug 22;17(1):417. doi: 10.1186/s13063-016-1543-6.
- Background: PubMed 11479161Clunk JM, Lin CY, Curtis JJ. Variables affecting weight gain in renal transplant recipients. Am J Kidney Dis. 2001 Aug;38(2):349-53. doi: 10.1053/ajkd.2001.26100.
- National Institute of Diabetes and Digestive and Kidney Diseases. Mission \& Vision. 2019 Accessed August, 30, 2019Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant and Kidney Transplant; Complications, run by Ohio State University 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 8 inclusion and 3 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 28 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Feasibility of the Study Recruitment for the Study (time frame: Baseline). The study lists 4 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 NCT05151445, which also lists 36 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 28 Oct 2024.