NCT02309528

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

November 18, 2014

Last Update Submit

August 27, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Blood Pressure

    Sept 2014-Sept 2015, baseline, 1-month, 6-month, and 12-month follow-up

  • Self-reported doctor visits and hospitalizations

    1-month, 6-month, and 12-month follow-up

  • Self-reported new medical conditions

    1-month, 6-month, and 12-month follow-up

  • Self-reported medication use and adherence

    1-month, 6-month, and 12-month follow-up

Interventions

computerized digital stories made by American Indians

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Strong Heart Study or Strong Heart Family Study participant

You may not qualify if:

  • End Stage Renal Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine; Staff Physician

Study Record Dates

First Submitted

November 18, 2014

First Posted

December 5, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations