Chronic Kidney DiseaseNCT02309528
Chronic Kidney Disease Knowledge and Awareness Among American Indians
A study testing Educational computerized digital stories in people with Chronic Kidney Disease, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Few educational intervention clinical trials have been conducted among those at risk for or with early chronic kidney disease. To the investigators' knowledge none have used digital storytelling as a means to deliver the educational message and have been conducted among American Indians, a group with high prevalence… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Educational computerized digital stories
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2015
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Strong Heart Study or Strong Heart Family Study participant
Who cannot join
- End Stage Renal Disease
Trial locations and contacts
1 site in 1 country.
About this study
Few educational intervention clinical trials have been conducted among those at risk for or with early chronic kidney disease. To the investigators' knowledge none have used digital storytelling as a means to deliver the educational message and have been conducted among American Indians, a group with high prevalence of chronic kidney disease and end stage kidney disease.
The aims of the research project are to:
- Quantify levels of chronic kidney disease knowledge and awareness among American Indians.
- Determine the effectiveness of a culturally tailored health presentation with computerized digital stories made by American Indians for improving chronic kidney disease knowledge and factors thought to be preventative of chronic kidney disease or its progression at baseline and follow-up in a pilot educational clinical intervention trial.
- Conditions
- Chronic Kidney Disease
- Being tested
- Educational computerized digital stories
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational computerized digital storiesOther
computerized digital stories made by American Indians
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Kidney Disease Knowledge
Survey of CKD Knowledge at baseline, post-intervention, 1-month follow up, 6 month follow up, and 12 month follow up
Measured: up to 12 months
Secondary outcomes (4)
Blood Pressure
average resting blood pressure collected via automated BP machine which has 5 minute rest period, then collects BP at 1 minute intervals for 3 measurements, and then calculates an average
Measured: Sept 2014-Sept 2015, baseline, 1-month, 6-month, and 12-month follow-up
Self-reported doctor visits and hospitalizations
Survey collection of self-reported doctor visits or hospitalizations
Measured: 1-month, 6-month, and 12-month follow-up
Self-reported new medical conditions
Survey collection of self-reported new diagnoses (i.e. diabetes, hypertension)
Measured: 1-month, 6-month, and 12-month follow-up
Self-reported medication use and adherence
Self-reported non-steroidal anti-inflammatory use and self-reported medication adherence of diabetes and/or blood pressure medications via the Morisky Medication Adherence Scale (MMAS-4)
Measured: 1-month, 6-month, and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacey Jolly, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309528
- Sponsor's protocol ID
- K23DK091363
- Status last verified
- Aug 2016
- First submitted
- 18 Nov 2014
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Kidney Disease Knowledge and Awareness Among American Indians
- ClinicalTrials.gov ID
- NCT02309528
- Acronym / sponsor ID
- K23DK091363
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Dec 2014 (estimated)
- 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.
Few educational intervention clinical trials have been conducted among those at risk for or with early chronic kidney disease. To the investigators' knowledge none have used digital storytelling as a means to deliver the educational message and have been conducted among American Indians, a group with high prevalence of chronic kidney disease and end stage kidney disease.
The aims of the research project are to:
- Quantify levels of chronic kidney disease knowledge and awareness among American Indians.
- Determine the effectiveness of a culturally tailored health presentation with computerized digital stories made by American Indians for improving chronic kidney disease knowledge and factors thought to be preventative of chronic kidney disease or its progression at baseline and follow-up in a pilot educational clinical intervention trial.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Strong Heart Study or Strong Heart Family Study participant
Key exclusion criteria (1 listed)
- End Stage Renal Disease
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 |
|---|---|---|
| Educational computerized digital storiescomputerized digital stories made by American Indians | Other | – |
Primary outcome
Chronic Kidney Disease Knowledge
Time frame: up to 12 months
Survey of CKD Knowledge at baseline, post-intervention, 1-month follow up, 6 month follow up, and 12 month follow up
4 secondary outcomes
Blood Pressure
Time frame: Sept 2014-Sept 2015, baseline, 1-month, 6-month, and 12-month follow-up
Self-reported doctor visits and hospitalizations
Time frame: 1-month, 6-month, and 12-month follow-up
Self-reported new medical conditions
Time frame: 1-month, 6-month, and 12-month follow-up
Self-reported medication use and adherence
Time frame: 1-month, 6-month, and 12-month follow-up
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 30 Aug 2016.
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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?
A study testing Educational computerized digital stories in people with Chronic Kidney Disease, run by The Cleveland 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 1 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 30 Aug 2016. 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?
Chronic Kidney Disease Knowledge (time frame: up to 12 months). 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 30 Aug 2016.