Self-Management and Resourceful Transition of Type 2 Diabetes With Stage 3 Kidney Disease (SMaRT)
|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: NCT01067963|
Recruitment Status : Terminated
First Posted : February 12, 2010
Last Update Posted : June 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Renal Insufficiency, Chronic||Behavioral: Computer assisted education and motivational interviewing. Behavioral: Group talks/social chat||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Self-management of Type 2 Diabetes and Chronic Kidney Disease|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Computer assisted education and telephone counseling using motivational interviewing.
Computer assisted education and motivational interviewing
Behavioral: Computer assisted education and motivational interviewing.
9 study contact points. 3-week intervention using computer-assisted learning modules and telephone counseling using motivational interviewing.
Other Name: Experimental Group
Placebo Comparator: Group talks/social chat
Group session talks on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content.
Behavioral: Group talks/social chat
9 study contact points. 3 group talk session on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content.
Other Name: Attention Control Group
- Primary outcomes utilized in this study will be disease burden (measured as diabetes-related distress), quality of life (measured as health related QOL), and glycemic health (measured as hemoglobin A1C). [ Time Frame: One year ]
- Secondary exploratory outcomes for quality of life include measures of health-related quality of life for diabetes and overall quality of life. [ Time Frame: One year ]
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): NCT01067963
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|VA Eastern Colorado Hospital|
|Denver, Colorado, United States, 80220|
|Principal Investigator:||Teresa J. Sakraida, PhD, RN||University of Colorado Denver College of Nursing|
|Principal Investigator:||Alkesh Jani, MD||University of Colorado Denver, School of Medicine and VA Eastern Colorado Hospital|