Acute Kidney InjuryChange AKINCT03114592
Understanding the Role of Patient Behavior Change in Improving AKI Outcomes
A study testing mHealth tool in people with Acute Kidney Injury, run by Duke University at 1 site in United States.
Trial summary
This study is looking to improve the safety of patients with acute kidney injury via education provided on a mobile tablet. This study will additionally examine if electronic tools, such as mobile tablets, can help. 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?
- mHealth tool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2017to 27 Aug 2018
- 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
- Diagnosis of acute kidney injury as diagnosed by renal care team
- On medical or surgical services
- Over 18 year of age
- Ability to read and speak English
Who cannot join
- Legal blindness or deafness
- Pregnant
- Cognitive impairment that limits ability to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: Understanding the Role of Patient Behavior Change in Improving AKI Outcomes (Change AKI Study)
This study is looking to improve the safety of patients with acute kidney injury via education provided on a mobile tablet. This study will additionally examine if electronic tools, such as mobile tablets, can help.
Read the detailed description
Acute kidney injury (AKI) is an increasingly common complication of acute hospitalizations. Hospital-related AKI, commonly caused by hemodynamic changes or contrast exposure, carries a threat of adverse outcomes that persists following hospital discharge, with an independent and graded association with long-term mortality. It is estimated that, approximately 13% of individuals with acute coronary syndrome (ACS) will develop some degree of AKI during their hospitalization. Survivors of AKI consume significantly greater health resources than the general population, and suffer exceedingly poor renal outcomes, including persistent loss of kidney function, progression to end stage renal disease (ESRD), and increased risk of recurrent AKI. It is estimated that 25% of individuals with an AKI-related hospitalization will be readmitted with recurrent AKI within 12 months of discharge, highlighting a critical need to address ongoing AKI risk once the acute hospitalization is complete. Patient-centered educational interventions that intensify awareness of potentially hazardous situations may reduce AKI recurrence. For example, commonly prescribed therapies such as diuretics or ACE inhibitors may threaten the renal safety of individuals at high risk of recurrent AKI if taken when significantly volume deplete, such as during an acute gastroenteritis, and in most cases should be held until one can eat and drink normally; Nonsteroidal Anti-inflammatory Drugs (NSAIDs) may exacerbate AKI risk if taken in combination with diuretics or ACE inhibitors even when volume replete and should be completely avoided. Tailored educational curricula surrounding these and other topics pertinent to AKI survivors may reduce recurrent hospitalizations and lower healthcare costs. In the absence of a patient centered outpatient approach to AKI education, the development of effective and sustainable AKI prevention strategies remains unlikely.
Our long-term goal is to develop patient-centered educational materials to reduce AKI recurrence. We hypothesize that a tailored educational curriculum will improve patient awareness of potential hazards and reduce AKI recurrence among hospital-based AKI survivors. Therefore, our overall objective for this proposal is to pilot test and evaluate the feasibility of a patient-centered mobile health (mHealth) educational curriculum for hospitalized AKI survivors at Duke Medical Center.
Aim 1: To test the feasibility and acceptance of a mHealth patient safety curriculum in hospitalized AKI survivors.
Hypothesis 1: Patient safety risk awareness at 1 month will be higher in the educational intervention arm than the usual care arm.
Aim 2: To determine if a mHealth educational curriculum improves patient safety behaviors in AKI survivors.
Hypothesis 2: High-risk safety behaviors will be reduced at 1 month in AKI survivors receiving the educational intervention, but not in the usual care arm.
- Conditions
- Acute Kidney Injury
- Being tested
- mHealth tool
- 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.
mHealth toolOther
The curriculum in the mHealth tool was derived in consultation with patient safety, informatics and adult educational curricula experts, and is comprised of clinical vignettes describing the post-hospital discharge stories of two hypothetical AKI survivors. opics of emphasis included NSAID risk awareness and avoidance of volume depletion when ill ("Sick Day Protocol").
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | * Complete a survey asking about kidney function and participant demographics. * Receive a one-month follow-up call (one month after hospital discharge date) and complete a phone survey about patient kidney function after discharge |
| mHealth Tool | Experimental | * Complete a survey asking about kidney function and participant demographics.
* Review a 15-20 minute educational tool on a tablet about kidney health
* Receive a one-month follow-up call (one month after hospital discharge date) and complete a phone survey about patient kidney function after discharge Receives: Other: mHealth tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Safety-Related Knowledge (Patient safety risk awareness)
mHealth tool and how knowledge changes pre/post intervention
Measured: Baseline, 1 month
Change in Patient Safety Behavior and Risk awareness
Survey assessing patient safety behavior and risk awareness
Measured: Baseline, 1 month
Secondary outcomes (1)
User Satisfaction
Satisfaction of mHealth tool
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start16 Jun 2017
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Duke 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarissa J Diamantidis, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114592
- Sponsor's protocol ID
- Pro00080287
- Acronym
- Change AKI
- Status last verified
- Jul 2018
- First submitted
- 11 Apr 2017
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of Patient Behavior Change in Improving AKI Outcomes (Change AKI Study)
- ClinicalTrials.gov ID
- NCT03114592
- Acronym / sponsor ID
- Change AKI / Pro00080287
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 14 Apr 2017 (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.
This study is looking to improve the safety of patients with acute kidney injury via education provided on a mobile tablet. This study will additionally examine if electronic tools, such as mobile tablets, can help.
Detailed description
Acute kidney injury (AKI) is an increasingly common complication of acute hospitalizations. Hospital-related AKI, commonly caused by hemodynamic changes or contrast exposure, carries a threat of adverse outcomes that persists following hospital discharge, with an independent and graded association with long-term mortality. It is estimated that, approximately 13% of individuals with acute coronary syndrome (ACS) will develop some degree of AKI during their hospitalization. Survivors of AKI consume significantly greater health resources than the general population, and suffer exceedingly poor renal outcomes, including persistent loss of kidney function, progression to end stage renal disease (ESRD), and increased risk of recurrent AKI. It is estimated that 25% of individuals with an AKI-related hospitalization will be readmitted with recurrent AKI within 12 months of discharge, highlighting a critical need to address ongoing AKI risk once the acute hospitalization is complete. Patient-centered educational interventions that intensify awareness of potentially hazardous situations may reduce AKI recurrence. For example, commonly prescribed therapies such as diuretics or ACE inhibitors may threaten the renal safety of individuals at high risk of recurrent AKI if taken when significantly volume deplete, such as during an acute gastroenteritis, and in most cases should be held until one can eat and drink normally; Nonsteroidal Anti-inflammatory Drugs (NSAIDs) may exacerbate AKI risk if taken in combination with diuretics or ACE inhibitors even when volume replete and should be completely avoided. Tailored educational curricula surrounding these and other topics pertinent to AKI survivors may reduce recurrent hospitalizations and lower healthcare costs. In the absence of a patient centered outpatient approach to AKI education, the development of effective and sustainable AKI prevention strategies remains unlikely.
Our long-term goal is to develop patient-centered educational materials to reduce AKI recurrence. We hypothesize that a tailored educational curriculum will improve patient awareness of potential hazards and reduce AKI recurrence among hospital-based AKI survivors. Therefore, our overall objective for this proposal is to pilot test and evaluate the feasibility of a patient-centered mobile health (mHealth) educational curriculum for hospitalized AKI survivors at Duke Medical Center.
Aim 1: To test the feasibility and acceptance of a mHealth patient safety curriculum in hospitalized AKI survivors.
Hypothesis 1: Patient safety risk awareness at 1 month will be higher in the educational intervention arm than the usual care arm.
Aim 2: To determine if a mHealth educational curriculum improves patient safety behaviors in AKI survivors.
Hypothesis 2: High-risk safety behaviors will be reduced at 1 month in AKI survivors receiving the educational intervention, but not in the usual care arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –* Complete a survey asking about kidney function and participant demographics. * Receive a one-month follow-up call (one month after hospital discharge date) and complete a phone survey about patient kidney function after discharge |
| mHealth Tool | Experimental | Other: mHealth tool* Complete a survey asking about kidney function and participant demographics. * Review a 15-20 minute educational tool on a tablet about kidney health * Receive a one-month follow-up call (one month after hospital discharge date) and complete a phone survey about patient kidney function after discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of acute kidney injury as diagnosed by renal care team
- On medical or surgical services
- Over 18 year of age
- Ability to read and speak English
Key exclusion criteria (3 listed)
- Legal blindness or deafness
- Pregnant
- Cognitive impairment that limits ability to consent
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 toolThe curriculum in the mHealth tool was derived in consultation with patient safety, informatics and adult educational curricula experts, and is comprised of clinical vignettes describing the post-hospital discharge stories of two hypothetical AKI survivors. opics of emphasis included NSAID risk awareness and avoidance of volume depletion when ill ("Sick Day Protocol"). | Other | mHealth Tool |
Primary outcome
Change in Patient Safety-Related Knowledge (Patient safety risk awareness)
Time frame: Baseline, 1 month
mHealth tool and how knowledge changes pre/post intervention
Change in Patient Safety Behavior and Risk awareness
Time frame: Baseline, 1 month
Survey assessing patient safety behavior and risk awareness
1 secondary outcome
User Satisfaction
Time frame: 5 minutes
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 13 Dec 2018.
- Individual participant dataSharing planned: No. We are not sharing IPD
Related trials for Acute Kidney Injury
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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.
Clarissa J Diamantidis, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth tool in people with Acute Kidney Injury, run by Duke 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 4 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 13 Dec 2018. 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?
Change in Patient Safety-Related Knowledge (Patient safety risk awareness) (time frame: Baseline, 1 month). 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?
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 13 Dec 2018.