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Trial record 10 of 1254 for:    veterans affairs medical center

HOPE Pilot for Veterans With Complex Diabetes (HOPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01274715
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes
Depression
Intervention: Behavioral: Behavioral Health Coaching

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period lasted from January 2011 through July 2011. After patients were screened, recruitment occurred over the phone, where they gave audio consent to participate in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three participants who gave consent to participate in the study met exclusion criteria at baseline and were removed from the study before being assigned to the intervention.

Reporting Groups
  Description
Behavioral Health Coaching Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.

Participant Flow:   Overall Study
    Behavioral Health Coaching
STARTED   12 
Screened Out at Baseline   3 
COMPLETED   8 
NOT COMPLETED   4 
Lost to Follow-up                1 
After consent, met exclusion criteria.                1 
After consent, met exclusion criteria.                1 
After consent, met exclusion criteria.                1 



  Baseline Characteristics

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
Behavioral Health Coaching Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.

Baseline Measures
   Behavioral Health Coaching 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.4  (5.71) 
Gender 
[Units: Participants]
 
Female   3 
Male   9 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures

1.  Primary:   Change in PHQ-9 (Patient Health Questionnaire-9)Scores   [ Time Frame: Baseline, 3 months, and 6 months ]

2.  Primary:   Change in Hemoglobin A1C   [ Time Frame: baseline, 3 months, and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  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
A very small sample was collected, and there was not a control group to compare to our intervention group.


  More Information

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


Results Point of Contact:  
Name/Title: Aanand Naik, MD
Organization: Michael DeBakey VAMC
phone: 713-794-8541
e-mail: anaik@bcm.edu


Publications of Results:

Responsible Party: Aanand Naik, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01274715     History of Changes
Other Study ID Numbers: VA ID 10G09.H
First Submitted: January 10, 2011
First Posted: January 11, 2011
Results First Submitted: October 25, 2012
Results First Posted: May 8, 2014
Last Update Posted: May 8, 2014