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Diabetes Mellitus, Type 2SMaRTNCT01067963

Self-Management and Resourceful Transition of Type 2 Diabetes With Stage 3 Kidney Disease

A study testing Computer assisted education and motivational interviewing. and Group talks/social chat in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, Chronic, run by University of Colorado, Denver at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Computer assisted education and motivational interviewing. and Group talks/social chat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesUnited States
Study dates
Dec 2009to Oct 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed Type 2 Diabetes
  • 18-85 years old
  • Stage 3 Chronic Kidney Disease
  • Speaks and reads English

Who cannot join

  • Hypoglycemia with 3rd party treatment in past 3 months
  • Type 1 Diabetes
  • On Dialysis
  • Does not speak English
  • Factors likely to preclude protocol adherence

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • VA Eastern Colorado Hospital

    Denver, Colorado, 80220

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Computer assisted education and motivational interviewing., Group talks/social chat
Keywords
self-care, self-management, health behavior change, motivational interviewing, computer assisted learning
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computer assisted education and motivational interviewing.Behavioural

    Also called Experimental Group

    9 study contact points. 3-week intervention using computer-assisted learning modules and telephone counseling using motivational interviewing.

  • Group talks/social chatBehavioural

    Also called Attention Control Group

    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.

Study groups in NCT01067963
Study groupRoleWhat they receive
Behavioral-education/counselingExperimentalComputer assisted education and telephone counseling using motivational interviewing. Computer assisted education and motivational interviewing
Receives: Behavioral: Computer assisted education and motivational interviewing.
Group talks/social chatPlacebo comparatorGroup session talks on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content.
Receives: Behavioral: Group talks/social chat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: One year

Secondary outcomes (1)

  1. Secondary exploratory outcomes for quality of life include measures of health-related quality of life for diabetes and overall quality of life.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01067963
Sponsor's protocol ID
08-0939
Other IDs
1UL1RR025780, RWJ64198
Acronym
SMaRT
Status last verified
Jan 2013
First submitted
10 Feb 2010
Last updated
9 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12500213

  • 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.

    PubMed 12502619

  • 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.

    PubMed 10837906

  • 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.

    PubMed 17699211

  • 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.

    PubMed 10739792

  • 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.

    PubMed 14629599

  • 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.

    PubMed 17276798

  • 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.

    PubMed 11194217

  • 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.

    PubMed 1620663

  • 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.

    PubMed 12649049

  • 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.

    PubMed 15983303

Questions about this trial

What is this clinical trial studying?

A study testing Computer assisted education and motivational interviewing. and Group talks/social chat in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, Chronic, run by University of Colorado, Denver at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01067963, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.

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