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Diabetes Self-Management Models to Reduce Health Disparities (P20-P2)

This study has been completed.
Sponsor:
Collaborator:
Texas A&M University
Information provided by (Responsible Party):
Sam Forjuoh, Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:
NCT01221090
First received: October 13, 2010
Last updated: August 7, 2013
Last verified: August 2013
Results First Received: June 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Type 2 Diabetes
Interventions: Behavioral: PDA
Behavioral: CDSMP
Behavioral: PDA/CDSMP

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CDSMP

6-week educational classes

CDSMP : 6-week classes

Personal Digital Assistant (PDA)

Personal digital assistance (technological)

PDA : Technological assistance

PDA/CDSMP

Combined intervention

PDA/CDSMP : Combined technology and education

Control Usual Care

Participant Flow:   Overall Study
    CDSMP     Personal Digital Assistant (PDA)     PDA/CDSMP     Control  
STARTED     101     81     99     95  
COMPLETED     86     47     57     73  
NOT COMPLETED     15     34     42     22  
Non-Compliant or Unable to Contact                 15                 12                 15                 20  
Withdrawal by Subject                 0                 22                 27                 2  



  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.
No text entered.

Reporting Groups
  Description
CDSMP

6-week educational classes

CDSMP : 6-week classes

Personal Digital Assistant (PDA)

Personal digital assistance (technological)

PDA : Technological assistance

PDA/CDSMP

Combined intervention

PDA/CDSMP : Combined technology and education

Control Usual Care
Total Total of all reporting groups

Baseline Measures
    CDSMP     Personal Digital Assistant (PDA)     PDA/CDSMP     Control     Total  
Number of Participants  
[units: participants]
  101     81     99     95     376  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     81     56     73     70     280  
>=65 years     20     25     26     25     96  
Age  
[units: years]
Mean ± Standard Deviation
  56.4  ± 10.8     57.7  ± 10.8     57.7  ± 10.3     58.5  ± 11.9     57.6  ± 10.9  
Gender  
[units: participants]
         
Female     54     47     53     53     207  
Male     47     34     46     42     169  
Region of Enrollment  
[units: participants]
         
United States     101     81     99     95     376  
Minority [1]
[units: Participants]
         
No     60     51     65     63     239  
Yes     41     30     34     32     137  
Race-Ethnicity  
[units: Participants]
         
Non-Hispanic White     58     49     61     58     226  
Non-Hispanic Black     21     11     12     17     61  
Hispanic     20     19     22     15     76  
Other     2     2     4     5     13  
Education  
[units: Participants]
         
Less than high school     6     4     3     3     16  
Some high school     4     3     8     1     16  
High school graduate     16     20     17     21     74  
Some college/vocational school     46     34     33     36     149  
College graduate     16     13     24     21     74  
Graduate school     13     7     14     13     47  
Income  
[units: Participants]
         
< $15,000     12     11     7     9     39  
$15,000 - $24,999     11     14     19     16     60  
$25,000 - $49,999     41     37     32     30     140  
$50,000 - $75,000     12     12     23     17     64  
> $75,000     12     6     14     14     46  
Prefer not to answer     13     1     4     9     27  
BMI  
[units: kg/m^2]
Mean ± Standard Deviation
  33.5  ± 8     35.3  ± 7.3     34.6  ± 6.3     33.9  ± 7.7     34.3  ± 7.4  
Systolic Blood Pressure  
[units: mm/Hg]
Mean ± Standard Deviation
  131.9  ± 14.1     138.5  ± 21.2     136.2  ± 19.1     132.9  ± 21.7     134.8  ± 19.3  
Diastolic Blood Pressure  
[units: mm/Hg]
Mean ± Standard Deviation
  79.4  ± 9.8     73.6  ± 11     78.8  ± 11.4     75.8  ± 13.6     77  ± 11.7  
HbA1c  
[units: %]
Mean ± Standard Deviation
  9.4  ± 1.7     9.3  ± 1.6     9.2  ± 1.4     9.2  ± 1.6     9.3  ± 1.6  
[1] Individuals categorized as minority were those who self-reported as either African American or Hispanic



  Outcome Measures
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1.  Primary:   HbA1c   [ Time Frame: 12 months ]

2.  Secondary:   BMI   [ Time Frame: 12 months ]

3.  Secondary:   Patient Self-reported Perceived Health Status   [ Time Frame: 12 months ]

4.  Secondary:   Diabetes-related Behaviors   [ Time Frame: 12 months ]

5.  Secondary:   Quality of Life (QOL)   [ Time Frame: 12 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
Differential dropout across interventions. Failure to obtain 50% minority and 50% non-minority participants, preventing further analyses regarding race/ethnicity differences in outcome. Could only provide information in an exploratory manner.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Samuel N. Forjuoh
Organization: Scott & White Hospital
phone: (254) 771-7695
e-mail: SFORJUOH@sw.org


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Sam Forjuoh, Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier: NCT01221090     History of Changes
Other Study ID Numbers: 071304, P20MD002295
Study First Received: October 13, 2010
Results First Received: June 3, 2013
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board