Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children (REDCHiP)
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|ClinicalTrials.gov Identifier: NCT03914547|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Behavioral: REDCHiP Behavioral: ATTN||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children|
|Actual Study Start Date :||October 15, 2019|
|Estimated Primary Completion Date :||March 31, 2024|
|Estimated Study Completion Date :||March 31, 2024|
REDCHiP uses 10- video-based telemedicine sessions to deliver T1D education, behavioral parent training, and problem-solving to enhance parents' knowledge and skills. Sessions last about 45-60 minutes each.
REDCHiP includes seven group-based sessions and three individual sessions. REDCHiP uses a three-pronged approach to reduce parents' FH. It uses T1D education and problem-solving to enhance parents' knowledge and skills. It uses child age-appropriate behavioral parent training to promote parents' skills and confidence in managing disruptive child behaviors and reducing their reliance on hypoglycemia avoidance behaviors. It uses cognitive-behavioral therapy strategies to help parents reduce maladaptive thinking/coping related to hypoglycemia fear.
Active Comparator: ATTN
ATTN uses 10- video-based telemedicine sessions to deliver general patient education specific to young children. Similar to REDCHiP, all ATTN sessions last 45-60 minutes.
Provides a similar attention control. ATTN includes seven group-based sessions and three individual sessions.
- Child Glycemic Control [ Time Frame: change from baseline to post-treatment (week 14) ]Child glycemic control will be measured by change in hemoglobin A1c (HbA1c) NGSP (%) between baseline and post-treatment.
- Parents Hypoglycemia Fear [ Time Frame: change from baseline to post-treatment (week 14) ]Parental fear will be measured by the Hypoglycemia Fear Survey - Parents of Young Children (HFS-PYC), a 26-item survey with a score range of 26-130. Higher scores indicate a higher fear rating.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914547
|Contact: Susana R Patton, PhD, CDEemail@example.com|
|Contact: Andrew McConville, BAfirstname.lastname@example.org|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32611|
|Contact: Kimberly Driscoll, PhD email@example.com|
|United States, Kansas|
|University of Kansas Medical Center||Not yet recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Susana Patton, PhD, CDE|
|United States, Missouri|
|The Children's Mercy Hospital||Recruiting|
|Kansas City, Missouri, United States, 64108|
|Contact: Mark Clements, MD PhD firstname.lastname@example.org|
|Principal Investigator:||Susana Patton, PhD, CDEemail@example.com|