Chronic Kidney Disease Knowledge and Awareness Among American Indians

August 27, 2016 updated by: Stacey Jolly, The Cleveland Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Strong Heart Study or Strong Heart Family Study participant

Exclusion Criteria:

  • End Stage Renal Disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Survey collection of self-reported doctor visits or hospitalizations
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
Survey collection of self-reported new diagnoses (i.e. diabetes, hypertension)
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
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)
1-month, 6-month, and 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 27, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23DK091363 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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