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Trial record 1 of 1 for:    NCT02309528
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Chronic Kidney Disease Knowledge and Awareness Among American Indians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02309528
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : August 30, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Stacey Jolly, The Cleveland Clinic

Brief 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 of chronic kidney disease and end stage kidney disease.

The aims of the research project are to:

  1. Quantify levels of chronic kidney disease knowledge and awareness among American Indians.
  2. 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Educational computerized digital stories Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Chronic Kidney Disease Knowledge and Awareness Among American Indians
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases


Intervention Details:
  • Other: Educational computerized digital stories
    computerized digital stories made by American Indians


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: Sept 2014-Sept 2015, baseline, 1-month, 6-month, and 12-month follow-up ]
    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

  2. Self-reported doctor visits and hospitalizations [ Time Frame: 1-month, 6-month, and 12-month follow-up ]
    Survey collection of self-reported doctor visits or hospitalizations

  3. Self-reported new medical conditions [ Time Frame: 1-month, 6-month, and 12-month follow-up ]
    Survey collection of self-reported new diagnoses (i.e. diabetes, hypertension)

  4. Self-reported medication use and adherence [ Time Frame: 1-month, 6-month, and 12-month follow-up ]
    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)



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Strong Heart Study or Strong Heart Family Study participant

Exclusion Criteria:

  • End Stage Renal Disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309528


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Responsible Party: Stacey Jolly, Assistant Professor of Medicine; Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02309528    
Other Study ID Numbers: K23DK091363 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency