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Linking Self-Management and Primary Care for Diabetes 2 (LB2)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CASM +
CASM
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes Mellitus focused on measuring RE AIM model, Type 2 Diabetes Mellitus, Interactive voice recognition, Computer Assisted Self Management

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaiser Permanente of Colorado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Computer Assisted Self Management plus Social Support

Usual care

Computer Assisted Self Management

Arm Description

an interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media combined with enhanced support in the form of group Diabetes Care Management visits and live follow up phone calls from Diabetes Care Managers

will receive a health-risk appraisal, interactive CD-ROM program that provides standardized advice on behavior change, but not the hypothesized key intervention processes of goal setting, barriers identification, problem solving, or social environmental support.

An interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media.

Outcomes

Primary Outcome Measures

Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status).

Secondary Outcome Measures

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.

Full Information

First Posted
September 29, 2009
Last Updated
May 21, 2015
Sponsor
Kaiser Permanente
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), InterVision, Oregon Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00987285
Brief Title
Linking Self-Management and Primary Care for Diabetes 2
Acronym
LB2
Official Title
Linking Self-Management and Primary Care for Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), InterVision, Oregon Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
RE AIM model, Type 2 Diabetes Mellitus, Interactive voice recognition, Computer Assisted Self Management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
463 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer Assisted Self Management plus Social Support
Arm Type
Experimental
Arm Description
an interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media combined with enhanced support in the form of group Diabetes Care Management visits and live follow up phone calls from Diabetes Care Managers
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
will receive a health-risk appraisal, interactive CD-ROM program that provides standardized advice on behavior change, but not the hypothesized key intervention processes of goal setting, barriers identification, problem solving, or social environmental support.
Arm Title
Computer Assisted Self Management
Arm Type
Experimental
Arm Description
An interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media.
Intervention Type
Behavioral
Intervention Name(s)
CASM +
Intervention Description
Computer Assisted Self Management plus Social Support
Intervention Type
Behavioral
Intervention Name(s)
CASM
Intervention Description
Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media
Primary Outcome Measure Information:
Title
Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status).
Time Frame
Baseline, 4 months and 12 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
4 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell E Glasgow, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80237-8066
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
background
PubMed Identifier
15275676
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. doi: 10.1016/j.amepre.2004.04.026.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
15919639
Citation
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. doi: 10.1177/0145721705276578.
Results Reference
background
PubMed Identifier
16414426
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. doi: 10.1016/j.amepre.2005.08.037.
Results Reference
background
PubMed Identifier
16542127
Citation
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. doi: 10.1207/s15324796abm3102_4.
Results Reference
background
PubMed Identifier
21371992
Citation
Glasgow RE, Christiansen SM, Kurz D, King DK, Woolley T, Faber AJ, Estabrooks PA, Strycker L, Toobert D, Dickman J. Engagement in a diabetes self-management website: usage patterns and generalizability of program use. J Med Internet Res. 2011 Jan 25;13(1):e9. doi: 10.2196/jmir.1391.
Results Reference
derived

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Linking Self-Management and Primary Care for Diabetes 2

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