Improving Quality of Care With a Digital Behavioral Program in IBD Patient Centered Medical Home
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03186872|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Irritable Bowel Disease||Behavioral: Digital behavioral program app||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Comparison between cognitive behavioral app and care as usual.|
|Masking:||None (Open Label)|
|Official Title:||Improving Quality of Care With a Digital Behavioral Program in IBD Patient Centered Medical Home|
|Actual Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
No Intervention: Care as usual
Participants randomized to this group will continue to see the IBD medical home team as usual
Experimental: Digital behavioral program app
Participants randomized to this group will see the IBD medical home team and will utilize the cognitive behavioral app as the intervention.
Behavioral: Digital behavioral program app
mobile app utilizing cognitive behavioral techniques to help alleviate anxiety
Other Name: Lantern
- GAD7 Score (Anxiety) [ Time Frame: 12 months ]GAD7 anxiety questionnaires are completed at time points throughout the study.
- PHQ-8 (Depression) [ Time Frame: 12 months ]The PHQ-8 questionnaire about depression is completed at different time points throughout the study.
- ACE Measure [ Time Frame: 12 months ]ACe questionnaire about health and health care is completed at time points throughout the study.
- Ulcerative Colitis Activity Index (UCAI)/Harvey Bradshaw (HB) [ Time Frame: 12 months ]The UCAI/HB questionnaires about IBD related chronic pain are completed at time points throughout the study. The subject completes the appropriate questionnaire based on IBD diagnosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186872
|Contact: Meredith Strassburger, MSWfirstname.lastname@example.org|
|Contact: Katheryn McAuliff, BAemail@example.com|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Meredith Strassburger, MSW 412-578-9530 firstname.lastname@example.org|
|Contact: Katheryn McAuliff, BA 412-578-9527 email@example.com|
|Principal Investigator:||Marc Schwartz, MD||University of Pittsburgh|
|Study Director:||Eva Szigethy, MD, PhD||University of Pittsburgh|