Self-Management and Resourceful Transition of Type 2 Diabetes With Stage 3 Kidney Disease (SMaRT)
Primary Purpose
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer assisted education and motivational interviewing.
Group talks/social chat
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring self-care, self-management, health behavior change, motivational interviewing, computer assisted learning
Eligibility Criteria
Inclusion Criteria:
- Diagnosed Type 2 Diabetes
- 18-85 years old
- Stage 3 Chronic Kidney Disease
- Speaks and reads English
Exclusion Criteria:
- Hypoglycemia with 3rd party treatment in past 3 months
- Type 1 Diabetes
- On Dialysis
- Does not speak English
- Factors likely to preclude protocol adherence
Sites / Locations
- University of Colorado Hospital
- VA Eastern Colorado Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Behavioral-education/counseling
Group talks/social chat
Arm Description
Computer assisted education and telephone counseling using motivational interviewing. Computer assisted education and motivational interviewing
Group session talks on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Secondary exploratory outcomes for quality of life include measures of health-related quality of life for diabetes and overall quality of life.
Full Information
NCT ID
NCT01067963
First Posted
February 10, 2010
Last Updated
June 5, 2015
Sponsor
University of Colorado, Denver
Collaborators
Robert Wood Johnson Foundation, National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT01067963
Brief Title
Self-Management and Resourceful Transition of Type 2 Diabetes With Stage 3 Kidney Disease
Acronym
SMaRT
Official Title
Self-management of Type 2 Diabetes and Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Robert Wood Johnson Foundation, National Center for Research Resources (NCRR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to establish the usefulness and the impact of a tailored behavioral-education and counseling intervention titled Self-Management and Resourceful Transition (S.M.a.R.T) among patients with type 2 diabetes mellitus and stage 3 chronic kidney disease, in order to help them to manage their behaviors related to their condition and health.
Detailed Description
The SMaRT intervention is a 3-week intervention that uses a combined behavioral-education and counseling methodology. The combined intervention involves computer-aided education alongside telephone counseling via motivational interviewing. The computer-aided education is tailored to the diagnoses of type 2 diabetes and chronic kidney disease and designed in a learning module approach to facilitate goal-setting and discussion of health concerns with greater efficacy and in a more informed way during the brief office visit. Such Computer-aided education has been used to improve diabetes self-management and glycemic control in middle-aged to older adults with moderate success. The inclusion of CKD information will augment current diabetes self-management intervention. The telephone counseling using the evidence-based behavioral change approach of motivational interviewing is a patient-centered approach of partnering with patients by eliciting their health-related concerns. This approach tailors the SMaRT intervention to include collaborative goal-setting with guidance based upon the patient's readiness for change.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Keywords
self-care, self-management, health behavior change, motivational interviewing, computer assisted learning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral-education/counseling
Arm Type
Experimental
Arm Description
Computer assisted education and telephone counseling using motivational interviewing.
Computer assisted education and motivational interviewing
Arm Title
Group talks/social chat
Arm Type
Placebo Comparator
Arm Description
Group session talks on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content.
Intervention Type
Behavioral
Intervention Name(s)
Computer assisted education and motivational interviewing.
Other Intervention Name(s)
Experimental Group
Intervention Description
9 study contact points. 3-week intervention using computer-assisted learning modules and telephone counseling using motivational interviewing.
Intervention Type
Behavioral
Intervention Name(s)
Group talks/social chat
Other Intervention Name(s)
Attention Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed Type 2 Diabetes
18-85 years old
Stage 3 Chronic Kidney Disease
Speaks and reads English
Exclusion Criteria:
Hypoglycemia with 3rd party treatment in past 3 months
Type 1 Diabetes
On Dialysis
Does not speak English
Factors likely to preclude protocol adherence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa J. Sakraida, PhD, RN
Organizational Affiliation
University of Colorado Denver College of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alkesh Jani, MD
Organizational Affiliation
University of Colorado Denver, School of Medicine and VA Eastern Colorado Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
VA Eastern Colorado Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12500213
Citation
Coresh J, Astor BC, Greene T, Eknoyan G, Levey AS. Prevalence of chronic kidney disease and decreased kidney function in the adult US population: Third National Health and Nutrition Examination Survey. Am J Kidney Dis. 2003 Jan;41(1):1-12. doi: 10.1053/ajkd.2003.50007.
Results Reference
background
PubMed Identifier
12502619
Citation
Franz MJ, Bantle JP, Beebe CA, Brunzell JD, Chiasson JL, Garg A, Holzmeister LA, Hoogwerf B, Mayer-Davis E, Mooradian AD, Purnell JQ, Wheeler M; American Diabetes Association. Evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. Diabetes Care. 2003 Jan;26 Suppl 1:S51-61. doi: 10.2337/diacare.26.2007.s51. No abstract available.
Results Reference
background
PubMed Identifier
10837906
Citation
Berridge E, Roudsari A, Taylor S, Carey S. Computer-aided learning for the education of patients and family practice professionals in the personal care of diabetes. Comput Methods Programs Biomed. 2000 Jul;62(3):191-204. doi: 10.1016/s0169-2607(00)00067-5.
Results Reference
background
Citation
National Kidney Foundation [NKF]. Kidney disease outcomes quality initiative (K/DOQI): Clinical Practice Guideline 2-evaluation and treatment 2002: Accessed March 21, 2008 from http://www.kidney.org/professionals/kdoqi/guidelines_ckd/p4_class_g2.htm.
Results Reference
background
PubMed Identifier
17699211
Citation
Khosla N, Bakris G. Lessons learned from recent hypertension trials about kidney disease. Clin J Am Soc Nephrol. 2006 Mar;1(2):229-35. doi: 10.2215/CJN.00840805. Epub 2005 Nov 30. No abstract available.
Results Reference
background
PubMed Identifier
10739792
Citation
Kshirsagar AV, Joy MS, Hogan SL, Falk RJ, Colindres RE. Effect of ACE inhibitors in diabetic and nondiabetic chronic renal disease: a systematic overview of randomized placebo-controlled trials. Am J Kidney Dis. 2000 Apr;35(4):695-707. doi: 10.1016/s0272-6386(00)70018-7.
Results Reference
background
Citation
National Kidney Foundation [NKF]. Kidney Disease Outcomes Quality Initiative (K/DOQI): Clinical Practice Guideline 9-assoc of level of GFR with nutritional status and Guideline 24-dietary protein intake for nondialyzed patients, 2002.
Results Reference
background
PubMed Identifier
14629599
Citation
Perlman RL, Kiser M, Finkelstein F, Eisele G, Roys E, Liu L, Burrows-Hudson S, Port F, Messana JM, Bailie G, Rajagopalan S, Saran R. The longitudinal chronic kidney disease study: a prospective cohort study of predialysis renal failure. Semin Dial. 2003 Nov-Dec;16(6):418-23. doi: 10.1046/j.1525-139x.2003.16093.x.
Results Reference
background
PubMed Identifier
17276798
Citation
KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.
Results Reference
background
PubMed Identifier
11194217
Citation
Glasgow RE, Hiss RG, Anderson RM, Friedman NM, Hayward RA, Marrero DG, Taylor CB, Vinicor F. Report of the health care delivery work group: behavioral research related to the establishment of a chronic disease model for diabetes care. Diabetes Care. 2001 Jan;24(1):124-30. doi: 10.2337/diacare.24.1.124.
Results Reference
background
Citation
Rollnick S, Mason P, Butler C. Health behavior change: A guide for practitioners. Edinburgh, Scotland: Churchill Livingstone Elsevier; 1999.
Results Reference
background
PubMed Identifier
1620663
Citation
Prochaska JO, DiClemente CC. Stages of change in the modification of problem behaviors. Prog Behav Modif. 1992;28:183-218. No abstract available.
Results Reference
background
Citation
Rollnick S, Miller WR, Butler CC. Motivational interviewing in health care: Helping patients change behavior. New York: Guilford Press; 2007.
Results Reference
background
PubMed Identifier
12649049
Citation
Glasgow RE, Boles SM, McKay HG, Feil EG, Barrera M Jr. The D-Net diabetes self-management program: long-term implementation, outcomes, and generalization results. Prev Med. 2003 Apr;36(4):410-9. doi: 10.1016/s0091-7435(02)00056-7.
Results Reference
background
PubMed Identifier
15983303
Citation
Gerber BS, Brodsky IG, Lawless KA, Smolin LI, Arozullah AM, Smith EV, Berbaum ML, Heckerling PS, Eiser AR. Implementation and evaluation of a low-literacy diabetes education computer multimedia application. Diabetes Care. 2005 Jul;28(7):1574-80. doi: 10.2337/diacare.28.7.1574.
Results Reference
background
PubMed Identifier
17716083
Citation
Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.
Results Reference
background
PubMed Identifier
2149753
Citation
Brown SA. Studies of educational interventions and outcomes in diabetic adults: a meta-analysis revisited. Patient Educ Couns. 1990 Dec;16(3):189-215. doi: 10.1016/0738-3991(90)90070-2.
Results Reference
background
PubMed Identifier
17579231
Citation
Himmelfarb J. Chronic kidney disease and the public health: gaps in evidence from interventional trials. JAMA. 2007 Jun 20;297(23):2630-3. doi: 10.1001/jama.297.23.2630. No abstract available.
Results Reference
background
PubMed Identifier
18165335
Citation
American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available.
Results Reference
background
PubMed Identifier
15367063
Citation
Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
Results Reference
background
PubMed Identifier
19390053
Citation
Sakraida TJ, Robinson MV. Health literacy self-management by patients with type 2 diabetes and stage 3 chronic kidney disease. West J Nurs Res. 2009 Aug;31(5):627-47. doi: 10.1177/0193945909334096. Epub 2009 Apr 23.
Results Reference
background
PubMed Identifier
7555499
Citation
Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.
Results Reference
background
PubMed Identifier
15735199
Citation
Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
Results Reference
background
PubMed Identifier
7841967
Citation
Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.
Results Reference
background
PubMed Identifier
10457741
Citation
Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res. 1999;8(1-2):79-91. doi: 10.1023/a:1026485130100.
Results Reference
background
Citation
Ware J, Snow K, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Centre;1993.
Results Reference
background
PubMed Identifier
1593914
Citation
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Results Reference
background
PubMed Identifier
11871587
Citation
Woodcock AJ, Julious SA, Kinmonth AL, Campbell MJ; Diabetes Care From Diagnosis Group. Problems with the performance of the SF-36 among people with type 2 diabetes in general practice. Qual Life Res. 2001;10(8):661-70. doi: 10.1023/a:1013837709224.
Results Reference
background
PubMed Identifier
11769298
Citation
Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
Results Reference
background
Citation
Kavookjian J, Berger B, Anderson-Harper H, Barker K, Grimley D, Pearson R, et al. The relationship between readiness for diabetes self-care and glycemic control: The development of a diagnostic tool for pharmacist intervention. Journal of American Pharmaceutical Association 41:320, 2001.
Results Reference
background
PubMed Identifier
10361528
Citation
Greene GW, Rossi SR, Rossi JS, Velicer WF, Fava JL, Prochaska JO. Dietary applications of the stages of change model. J Am Diet Assoc. 1999 Jun;99(6):673-8. doi: 10.1016/S0002-8223(99)00164-9. No abstract available.
Results Reference
background
PubMed Identifier
18248105
Citation
Hellsten LA, Nigg C, Norman G, Burbank P, Braun L, Breger R, Coday M, Elliot D, Garber C, Greaney M, Lees F, Matthews C, Moe E, Resnick B, Riebe D, Rossi J, Toobert D, Wang T. Accumulation of behavioral validation evidence for physical activity stage of change. Health Psychol. 2008 Jan;27(1S):S43-53. doi: 10.1037/0278-6133.27.1(Suppl.).S43.
Results Reference
background
PubMed Identifier
7930314
Citation
Greene GW, Rossi SR, Reed GR, Willey C, Prochaska JO. Stages of change for reducing dietary fat to 30% of energy or less. J Am Diet Assoc. 1994 Oct;94(10):1105-10; quiz 1111-2. doi: 10.1016/0002-8223(94)91127-4.
Results Reference
background
PubMed Identifier
10895844
Citation
Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
Results Reference
background
Citation
Stanford Patient Education Research Center, Self Efficacy for Diabetes. Stanford (Accessed March 28, 2008, at http://patienteducation.stanford.edu/research/sediabetes.html.)
Results Reference
background
Citation
National Kidney Foundation [NKF]. Kidney disease outcomes quality initiative (K/DOQI): Clinical practice Guideline 4-Estimation of GFR Part 5 evaluation of laboratory measures for clinical assessment of kidney disease. 2002: Accessed March 27, 2008 from http://www.kidney.org/professionals/kdoqi/guidelines_ckd/p5_lab_g4.htm.
Results Reference
background
PubMed Identifier
3640358
Citation
Lynn MR. Determination and quantification of content validity. Nurs Res. 1986 Nov-Dec;35(6):382-5. No abstract available.
Results Reference
background
PubMed Identifier
7828382
Citation
Sheiner LB, Rubin DB. Intention-to-treat analysis and the goals of clinical trials. Clin Pharmacol Ther. 1995 Jan;57(1):6-15. doi: 10.1016/0009-9236(95)90260-0. No abstract available.
Results Reference
background
PubMed Identifier
9786807
Citation
Aubert RE, Herman WH, Waters J, Moore W, Sutton D, Peterson BL, Bailey CM, Koplan JP. Nurse case management to improve glycemic control in diabetic patients in a health maintenance organization. A randomized, controlled trial. Ann Intern Med. 1998 Oct 15;129(8):605-12. doi: 10.7326/0003-4819-129-8-199810150-00004.
Results Reference
background
Learn more about this trial
Self-Management and Resourceful Transition of Type 2 Diabetes With Stage 3 Kidney Disease
We'll reach out to this number within 24 hrs