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)
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  
Number of Participants  
[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  
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 [2]
[units: Participants]
     
Limited     58     50     108  
Adequate     68     75     143  
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 [3]
[units: Participants]
     
≤ $20,000     73     75     148  
$20,001 - $30,000     24     25     49  
>$30,000     19     19     38  
Financial Class - Insurance Type [4]
[units: Participants]
     
Medicaid     28     22     50  
Medicare     4     7     11  
Uninsured / Commercial     1     2     3  
Healthy Worker / Healthy San Francisco     93     94     187  
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 [5]
[units: Participants]
     
> 8.0%     37     29     66  
≤ 8.0%     87     90     177  
Hemoglobin A1c [5]
[units: %]
Mean ± Standard Deviation
  7.8  ± 1.6     7.5  ± 1.3     7.7  ± 1.5  
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  
[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.
[2] Data is based on the 252 participants with both baseline and 6-month follow-up measures and with answers to all health literacy questions.
[3] 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.
[4] Data is based on the 252 participants with both baseline and 6-month follow-up measures and with financial class information.
[5] Data is based on the 252 participants with both baseline and 6-month follow-up measures and with Hemoglobin A1c data.



  Outcome Measures
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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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


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


No publications provided by University of California, San Francisco

Publications automatically indexed to this study:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00683020     History of Changes
Other Study ID Numbers: R18HS017261
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