Self-Management and Resourceful Transition of Type 2 Diabetes With Stage 3 Kidney Disease (SMaRT)
5. června 2015 aktualizováno: University of Colorado, Denver
Self-management of Type 2 Diabetes and Chronic Kidney Disease
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.
Přehled studie
Postavení
Ukončeno
Detailní popis
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.
Typ studie
Intervenční
Zápis (Očekávaný)
80
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- University of Colorado Hospital
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Denver, Colorado, Spojené státy, 80220
- VA Eastern Colorado Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 85 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Behavioral-education/counseling
Computer assisted education and telephone counseling using motivational interviewing. Computer assisted education and motivational interviewing |
9 study contact points.
3-week intervention using computer-assisted learning modules and telephone counseling using motivational interviewing.
Ostatní jména:
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Komparátor placeba: 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.
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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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).
Časové okno: One year
|
One year
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Secondary exploratory outcomes for quality of life include measures of health-related quality of life for diabetes and overall quality of life.
Časové okno: One year
|
One year
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Teresa J. Sakraida, PhD, RN, University of Colorado Denver College of Nursing
- Vrchní vyšetřovatel: Alkesh Jani, MD, University of Colorado Denver, School of Medicine and VA Eastern Colorado Hospital
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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- 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.
- 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.
- Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.
- 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.
- 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.
- 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.
- 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.
- 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.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Rollnick S, Mason P, Butler C. Health behavior change: A guide for practitioners. Edinburgh, Scotland: Churchill Livingstone Elsevier; 1999.
- Prochaska JO, DiClemente CC. Stages of change in the modification of problem behaviors. Prog Behav Modif. 1992;28:183-218. No abstract available.
- Rollnick S, Miller WR, Butler CC. Motivational interviewing in health care: Helping patients change behavior. New York: Guilford Press; 2007.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Stanford Patient Education Research Center, Self Efficacy for Diabetes. Stanford (Accessed March 28, 2008, at http://patienteducation.stanford.edu/research/sediabetes.html.)
- 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.
- Lynn MR. Determination and quantification of content validity. Nurs Res. 1986 Nov-Dec;35(6):382-5. No abstract available.
- 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.
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. prosince 2009
Primární dokončení (Aktuální)
1. října 2012
Dokončení studie (Aktuální)
1. října 2012
Termíny zápisu do studia
První předloženo
10. února 2010
První předloženo, které splnilo kritéria kontroly kvality
11. února 2010
První zveřejněno (Odhad)
12. února 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
9. června 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
5. června 2015
Naposledy ověřeno
1. ledna 2013
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 08-0939
- 1UL1RR025780 (Grant/smlouva NIH USA)
- RWJ64198 (Jiné číslo grantu/financování: Robert Wood Johnson Foundation)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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