Chronic Kidney Disease Knowledge and Awareness Among American Indians

Chronic Kidney Disease Clinical Trial

Official title:

Chronic Kidney Disease Knowledge and Awareness Among American Indians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309528
• Other study ID #: K23DK091363
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: August 27, 2016
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Strong Heart Study or Strong Heart Family Study participant

Exclusion Criteria:

• End Stage Renal Disease

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 12 months	No
Secondary	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	Sept 2014-Sept 2015, baseline, 1-month, 6-month, and 12-month follow-up	No
Secondary	Self-reported doctor visits and hospitalizations	Survey collection of self-reported doctor visits or hospitalizations	1-month, 6-month, and 12-month follow-up	No
Secondary	Self-reported new medical conditions	Survey collection of self-reported new diagnoses (i.e. diabetes, hypertension)	1-month, 6-month, and 12-month follow-up	No
Secondary	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)	1-month, 6-month, and 12-month follow-up	No