Acute Kidney InjuryNCT05184894
A Study of Acute Kidney Injury in Care Transitions
A study testing AKI in Care Transitions (ACT) program in people with Acute Kidney Injury, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to develop materials and processes that will help facilitate education and kidney care coordination for AKI survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- AKI in Care Transitions (ACT) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2022to 31 Oct 2023
- Phase
- Interventional
- 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
Who may be able to join
- Participants will be recruited from those identified by a developed electronic health record list of patients with stage III AKI (severe) during a hospitalization based on serum creatinine rise or urine output decline from Olmsted County.
Who cannot join
- Dementia.
- Non-English speaking.
- Expected to be dismissed to a skilled nursing facility or hospice at discharge.
- Expected to need dialysis at discharge.
- Primary Care Transitions Program enrollment.
- Transplant recipients within 100 days of transplant.
- Can only have one time enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: AKI in Care Transitions (ACT) Trial
This research is being done to develop materials and processes that will help facilitate education and kidney care coordination for AKI survivors.
- Conditions
- Acute Kidney Injury
- Being tested
- AKI in Care Transitions (ACT) program
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKI in Care Transitions (ACT) programBehavioural
Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge.
| Study group | Role | What they receive |
|---|---|---|
| AKI in Care Transitions (ACT) Group | Experimental | Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay. Receives: Behavioral: AKI in Care Transitions (ACT) program |
| Usual Care Group | No intervention | Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects to Complete the ACT Program
Total number of subjects to complete the full ACT program intervention
Measured: 30 days after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start17 Jan 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 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 (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Erin Barreto, Mayo Clinic
- Investigators
- Erin Barreto, PharmD, RPh, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184894
- Sponsor's protocol ID
- 21-011055
- Other IDs
- R03HS028060-01
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2021
- Last updated
- 18 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
May HP, Griffin JM, Herges JR, Kashani KB, Kattah AG, Mara KC, McCoy RG, Rule AD, Tinaglia AG, Barreto EF. Comprehensive Acute Kidney Injury Survivor Care: Protocol for the Randomized Acute Kidney Injury in Care Transitions Pilot Trial. JMIR Res Protoc. 2023 May 22;12:e48109. doi: 10.2196/48109.
PubMed 37213187
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AKI in Care Transitions (ACT) Trial
- ClinicalTrials.gov ID
- NCT05184894
- Acronym / sponsor ID
- 21-011055
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to develop materials and processes that will help facilitate education and kidney care coordination for AKI survivors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI in Care Transitions (ACT) Group | Experimental | Behavioral: AKI in Care Transitions (ACT) programSubjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay. |
| Usual Care Group | No intervention | –Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be recruited from those identified by a developed electronic health record list of patients with stage III AKI (severe) during a hospitalization based on serum creatinine rise or urine output decline from Olmsted County.
Key exclusion criteria (7 listed)
- Dementia.
- Non-English speaking.
- Expected to be dismissed to a skilled nursing facility or hospice at discharge.
- Expected to need dialysis at discharge.
- Primary Care Transitions Program enrollment.
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 |
|---|---|---|
| AKI in Care Transitions (ACT) programMulticomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge. | Behavioural | AKI in Care Transitions (ACT) Group |
Primary outcome
Number of Subjects to Complete the ACT Program
Time frame: 30 days after hospitalization
Total number of subjects to complete the full ACT program intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37213187May HP, Griffin JM, Herges JR, Kashani KB, Kattah AG, Mara KC, McCoy RG, Rule AD, Tinaglia AG, Barreto EF. Comprehensive Acute Kidney Injury Survivor Care: Protocol for the Randomized Acute Kidney Injury in Care Transitions Pilot Trial. JMIR Res Protoc. 2023 May 22;12:e48109. doi: 10.2196/48109.
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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.
Erin Barreto, PharmD, RPh principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKI in Care Transitions (ACT) program in people with Acute Kidney Injury, run by Mayo Clinic 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 1 inclusion and 7 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 18 Dec 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 25 Nov 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?
Number of Subjects to Complete the ACT Program (time frame: 30 days after hospitalization). 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 NCT05184894, which also lists 1 linked publication.
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 18 Dec 2024.