Linking Self-Management and Primary Care for Diabetes 2

Type 2 Diabetes Mellitus Clinical Trial

— LB2  

Official title:

Linking Self-Management and Primary Care for Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987285
• Other study ID #: 2 R01 DK035524-21
• Secondary ID: R01DK035524
• Status: Completed
• Phase: N/A
• First received: September 29, 2009
• Last updated: May 21, 2015
• Start date: January 2007
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This project is primarily a behavioral study. We employed a three-arm, patient-randomized practical effectiveness trial to evaluate the impact of two different interactive, multimedia self-management programs, relative to "enhanced" usual care. The two interventions will be (a) the revised program from our present study, based on our social-ecological theory and the 5 As self-management model, plus enhanced support (ASM+ES) that includes practical, but extensive, ongoing support and b) largely Automated Self-Management (ASM). These programs will be compared to a realistic "enhanced usual care" (UC) condition that will provide health risk appraisal feedback, control for computer interactions, and provide standardized advice on behavior change, but not the hypothesized key intervention processes of goal-setting, barriers identification, problem-solving, or social-environmental support. Patients will be randomized to conditions within clinic and will participate for 1 year.

The proposed project will test the effectiveness of a practical, automated-based intervention for primary care patients to facilitate dietary and physical activity practices, and medication-taking. Analyses will focus on primary outcomes of (a) dietary, physical activity, medication-taking outcomes, and (b) the UKPDS risk equation as well as secondary quality-of-life, patient-activation, and patient care outcomes (Specific Aim #2). Using the RE-AIM measures, we will analyze the reach, effectiveness, adoption, implementation, and maintenance of the intervention programs (Specific Aim #3), and also factors related to program implementation, linkage to primary care, and program success with emphasis on cost, cost-effectiveness, and mediators and moderators of outcomes such as social-environment support (Aim #4).

Primary hypotheses:

1. That the Automated Intervention received by Automated self-management (ASM) condition and ASM plus enhanced support conditions (ASM+ES) will be superior to usual care on the primary outcomes.

2. That the ASM+ES condition will be superior to the ASM alone condition on primary outcomes at the 12-month follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: December 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria:

• being 25-75 years of age,

• live independently,

• have a telephone,

• are able to read in either English or Spanish,

• able to access the Internet at least twice per week

• are capable of providing informed consent,

• have been diagnosed with type 2 diabetes for at least 1 year

• are overweight (BMI = 25), and

• have at least one additional UKPDS equation risk factor (i.e., high lipids, hypertension, HbA1c, or smoking)

Exclusion Criteria:

• Exclusion criteria:

• Suffering dementia or active psychosis,

• Being on end-stage dialysis,

• or predicted to live fewer than 2 years

• Being institutionalized.

• Pregnant women - women with gestational diabetes will not be enrolled, because there needs are quite different, but we won't specifically exclude women who are pregnant AND otherwise eligible, since we do acknowledge that it's possible that someone may be unaware that they are pregnant at the time of enrollment, or may become pregnant during the study, and that this will not affect their continued participation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• CASM +
Computer Assisted Self Management plus Social Support
• CASM
Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media

Locations

Country	Name	City	State
United States	Kaiser Permanente of Colorado	Denver	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	InterVision, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Oregon Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (6)

Estabrooks PA, Nelson CC, Xu S, King D, Bayliss EA, Gaglio B, Nutting PA, Glasgow RE. The frequency and behavioral outcomes of goal choices in the self-management of diabetes. Diabetes Educ. 2005 May-Jun;31(3):391-400. — View Citation

Glasgow RE, Bull SS, Piette JD, Steiner JF. Interactive behavior change technology. A partial solution to the competing demands of primary care. Am J Prev Med. 2004 Aug;27(2 Suppl):80-7. Review. — View Citation

Glasgow RE, Nelson CC, Strycker LA, King DK. Using RE-AIM metrics to evaluate diabetes self-management support interventions. Am J Prev Med. 2006 Jan;30(1):67-73. — View Citation

Glasgow, R.E., Nutting, P.A. (2004) Diabetes. Handbook of Primary Care Psychology. L. Haas (Editor) Oxford University Press, New York, pp 299-319.

King DK, Estabrooks PA, Strycker LA, Toobert DJ, Bull SS, Glasgow RE. Outcomes of a multifaceted physical activity regimen as part of a diabetes self-management intervention. Ann Behav Med. 2006 Apr;31(2):128-37. — View Citation

King, D.K., Glasgow, R.E. (2004) Self-management of Type 2 Diabetes: Key Issues, Evidence-Based Recommendations, and Future Directions. In: Best Practices in the Behavioral Management of Chronic Disease, J. Trafton & William Gordon (Eds.). Institute for Disease Management, Los Altos, CA, Vol 2, Chapter 9.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status).		Baseline, 4 months and 12 months	No
Secondary	Diabetes-specific quality of life (Diabetes Distress Scale), patient activation (PAM scale), and perceived social-environmental support (the Chronic Illness Resources Survey) at 4- and 12-month follow-ups.		4 and 12 months	No