Acute Kidney InjuryNCT04505891
Enhanced Kidney Follow-up for AKI Survivors in Care Transitions
A study testing Education and Education and follow-up in people with Acute Kidney Injury, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess the ability of education and outpatient kidney care follow-up in order to improve patient knowledge about acute kidney injury (AKI). 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?
- Education and Education and follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 21 Dec 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
- KDIGO Stage 3 AKI
- Primary care provider at Mayo Rochester.
Who cannot join
- Patient with need for dialysis at discharge from hospital or hospice.
- Enrolled in the Primary Care Transition Program.
- Non-English speaking.
- Cognitive impairment.
- Dementia.
- Mini-Cog score of less than 3.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Enhanced Kidney Follow-up for AKI Survivors in Care Transitions (The ACT Study): Impact on Patient Reported Outcomes
The purpose of this study is to assess the ability of education and outpatient kidney care follow-up in order to improve patient knowledge about acute kidney injury (AKI).
- Conditions
- Acute Kidney Injury
- Being tested
- Education, Education and follow-up
- Keywords
- transitions of care, education, patient reported outcomes, chronic kidney disease, acute kidney injury
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Kidney health education will be delivered prior to discharge by trained nurse educators.
Education and follow-upBehavioural
In patients allocated to the education and follow-up arm, education along with a a post-discharge healthcare visit from a multidisciplinary care team will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Education alone | Active comparator | Not described Receives: Behavioral: Education |
| Education and follow-up | Active comparator | Not described Receives: Behavioral: Education and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Kidney Knowledge Survey (mKIKS)
Assesses participants' objective knowledge about AKI causes, risk factors, and management. The minimum score is 0, maximum score is 15, higher scores indicate greater knowledge.
Measured: 14-days after last study contact
Secondary outcomes (2)
Brief health literacy screen
A 4-item tool to assess health literacy. Minimum score of 0, maximum score 20, higher scores indicate higher health literacy
Measured: 30-days post hospitalization
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10
Based on the provided responses, an overall summary score, and two subset scores - Global health physical and Global health mental can be calculated. Raw summed score are converted into T-scores. Higher scores indicate better health.
Measured: 30-days post hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start17 Aug 2020
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Barreto, Mayo Clinic
- Investigators
- Erin F Barreto, PharmD, RPh, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505891
- Sponsor's protocol ID
- 20-004204
- Status last verified
- Jan 2022
- First submitted
- 4 Aug 2020
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
May HP, Herges JR, Anderson BK, Hanson GJ, Kashani KB, Kattah AG, Cole KC, McCoy RG, Meade LA, Rule AD, Schreier DJ, Tinaglia AG, Barreto EF; ACT Study Group. Posthospital Multidisciplinary Care for AKI Survivors: A Feasibility Pilot. Kidney Med. 2023 Oct 5;5(12):100734. doi: 10.1016/j.xkme.2023.100734. eCollection 2023 Dec.
PubMed 37964784
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Kidney Follow-up for AKI Survivors in Care Transitions (The ACT Study): Impact on Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT04505891
- Acronym / sponsor ID
- 20-004204
- Conditions
- Acute Kidney Injury
- Keywords
- transitions of care, education, patient reported outcomes, chronic kidney disease, acute kidney injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 10 Aug 2020 (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.
The purpose of this study is to assess the ability of education and outpatient kidney care follow-up in order to improve patient knowledge about acute kidney injury (AKI).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Education alone | Active comparator | Behavioral: Education |
| Education and follow-up | Active comparator | Behavioral: Education and follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- KDIGO Stage 3 AKI
- Primary care provider at Mayo Rochester.
Key exclusion criteria (6 listed)
- Patient with need for dialysis at discharge from hospital or hospice.
- Enrolled in the Primary Care Transition Program.
- Non-English speaking.
- Cognitive impairment.
- 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 |
|---|---|---|
| EducationKidney health education will be delivered prior to discharge by trained nurse educators. | Behavioural | Education alone |
| Education and follow-upIn patients allocated to the education and follow-up arm, education along with a a post-discharge healthcare visit from a multidisciplinary care team will be performed. | Behavioural | Education and follow-up |
Primary outcome
Modified Kidney Knowledge Survey (mKIKS)
Time frame: 14-days after last study contact
Assesses participants' objective knowledge about AKI causes, risk factors, and management. The minimum score is 0, maximum score is 15, higher scores indicate greater knowledge.
2 secondary outcomes
Brief health literacy screen
Time frame: 30-days post hospitalization
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10
Time frame: 30-days post hospitalization
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 5 Jan 2022.
- Derived from this study: PubMed 37964784May HP, Herges JR, Anderson BK, Hanson GJ, Kashani KB, Kattah AG, Cole KC, McCoy RG, Meade LA, Rule AD, Schreier DJ, Tinaglia AG, Barreto EF; ACT Study Group. Posthospital Multidisciplinary Care for AKI Survivors: A Feasibility Pilot. Kidney Med. 2023 Oct 5;5(12):100734. doi: 10.1016/j.xkme.2023.100734. eCollection 2023 Dec.
- Mayo Clinic Clinical TrialsLink 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.
Erin F 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 Education and Education and follow-up 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 2 inclusion and 6 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 5 Jan 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?
Modified Kidney Knowledge Survey (mKIKS) (time frame: 14-days after last study contact). 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 NCT04505891, 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 5 Jan 2022.