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Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan (SMARTSteps)

This study has been completed.
Sponsor:
Collaborators:
San Francisco Health Plan (SFHP)
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00683020
First received: May 21, 2008
Last updated: May 14, 2013
Last verified: May 2013
Results First Received: December 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Diabetes
Intervention: Behavioral: ATSM Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study sample was drawn from San Francisco Health Plan The study sample was drawn April 2009 – March 2011 from San Francisco Health Plan (SFHP) members who received primary care at one of four publicly-funded clinics in the Community Health Network of San Francisco (CHNSF).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
SFHP members deemed eligible were English-, Cantonese-, or Spanish-speaking adults (age 18 or above) with ≥1 primary care clinic visit in the preceding 24 months, had diabetes diagnosis, and access to a touch-tone phone. Members who were pregnant, unable to provide verbal consent, or leaving the region in the next 12 months were ineligible.

Reporting Groups
  Description
ATSM Intervention ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control WAIT LIST Control: six month Wait List.

Participant Flow:   Overall Study
    ATSM Intervention   WAIT LIST Control
STARTED   182   180 
COMPLETED   127   125 
NOT COMPLETED   55   55 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data is based on the 252 participants with both baseline and 6-month follow-up measures.

Reporting Groups
  Description
ATSM Intervention ATSM Intervention: Automated Telephone Self-Management Support.
WAIT LIST Control WAIT LIST Control: six month Wait List.
Total Total of all reporting groups

Baseline Measures
   ATSM Intervention   WAIT LIST Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 127   125   252 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.5  (7.9)   55.0  (8.6)   55.7  (8.2) 
Gender 
[Units: Participants]
     
Female   98   89   187 
Male   29   36   65 
Race/Ethnicity, Customized 
[Units: Participants]
     
Latino   32   25   57 
Black / African-American   7   12   19 
Asian / Pacific Islander   77   78   155 
White / Caucasian   7   9   16 
Multi-Ethnic / Other   4   1   5 
Birth Place 
[Units: Participants]
     
Outside U.S.   110   106   216 
Inside U.S.   17   19   36 
Language 
[Units: Participants]
     
Cantonese   69   69   138 
Spanish   25   23   48 
English   33   33   66 
Language Concordance with Primary Care Provider [1] 
[Units: Participants]
     
Concordant   33   26   59 
Discordant   57   62   119 
[1] Data is based on the 252 participants with baseline and 6-month follow-up measures, Cantonese- or Spanish-speaking, and with a regular primary care provider.
Educational Attainment 
[Units: Participants]
     
8th grade education or less   50   58   108 
Some high school   13   12   25 
High school graduate or GED   33   22   55 
College graduate or above   31   33   64 
Health Literacy [1] 
[Units: Participants]
     
Limited   58   50   108 
Adequate   68   75   143 
[1] Data is based on the 252 participants with both baseline and 6-month follow-up measures and with answers to all health literacy questions.
Employment Status 
[Units: Participants]
     
Employed full-time   28   26   54 
Part-time   63   58   121 
Unemployed   12   15   27 
Disabled   7   13   20 
Homemaker / Retired / Other   17   13   30 
Annual Household Income [1] 
[Units: Participants]
     
≤ $20,000   73   75   148 
$20,001 - $30,000   24   25   49 
>$30,000   19   19   38 
[1] Data is based on the 252 participants with both baseline and 6-month follow-up measures and with answer to the question on annual household income.
Financial Class - Insurance Type [1] 
[Units: Participants]
     
Medicaid   28   22   50 
Medicare   4   7   11 
Uninsured / Commercial   1   2   3 
Healthy Worker / Healthy San Francisco   93   94   187 
[1] Data is based on the 252 participants with both baseline and 6-month follow-up measures and with financial class information.
Diabetes Duration 
[Units: Years]
Mean (Standard Deviation)
 6.9  (5.9)   7.2  (5.4)   7.0  (5.7) 
Insulin Treatment 
[Units: Participants]
     
Yes   25   18   43 
No   102   107   209 
Hemoglobin A1c [1] 
[Units: Participants]
     
> 8.0%   37   29   66 
≤ 8.0%   87   90   177 
[1] Data is based on the 252 participants with both baseline and 6-month follow-up measures and with Hemoglobin A1c data.
Hemoglobin A1c [1] 
[Units: %]
Mean (Standard Deviation)
 7.8  (1.6)   7.5  (1.3)   7.7  (1.5) 
[1] Data is based on the 252 participants with both baseline and 6-month follow-up measures and with Hemoglobin A1c data.
Systolic Blood Pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 127.3  (17.3)   128.1  (18.2)   127.7  (17.7) 
Diastolic Blood Pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 72.9  (9.3)   76.1  (9.9)   74.5  (9.7) 
Low-density Lipoprotein 
[Units: mg/dL]
Mean (Standard Deviation)
 92.7  (30.3)   93.5  (31.5)   93.1  (30.8) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes in the Physical Component Summary of the SF-12 Health Survey   [ Time Frame: Baseline and 6 months ]

2.  Primary:   Changes in the Mental Component Summary of the SF-12 Health Survey   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Number of Days Spent in Bed Due to Illness   [ Time Frame: 6 months ]

4.  Secondary:   Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities   [ Time Frame: 6 months ]

5.  Secondary:   Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale   [ Time Frame: Baseline and 6 months ]

6.  Secondary:   Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale   [ Time Frame: Baseline and 6 months ]

7.  Secondary:   Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale   [ Time Frame: Baseline and 6 months ]

8.  Secondary:   Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale   [ Time Frame: Baseline and 6 months ]

9.  Secondary:   Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale   [ Time Frame: Baseline and 6 months ]

10.  Secondary:   Changes in Hemoglobin A1c Levels   [ Time Frame: Baseline and 6 months ]

11.  Secondary:   Changes in Systolic Blood Pressure (SBP)   [ Time Frame: Baseline and 6 months ]

12.  Secondary:   Changes in Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dean Schillinger, MD/Study Principal Investigator
Organization: University of California, San Francisco
phone: 415-206-8940
e-mail: dschillinger@medsfgh.ucsf.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00683020     History of Changes
Other Study ID Numbers: R18HS017261 ( US NIH Grant/Contract Award Number )
Study First Received: May 21, 2008
Results First Received: December 10, 2012
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government