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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 
Overall Participants Analyzed 
[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 
[1] Individuals categorized as minority were those who self-reported as either African American or Hispanic
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) 


  Outcome Measures
  Show All Outcome Measures

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 by ClinicalTrials.gov Identifier (NCT Number):

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