Strengths-Based Behavioral mHealth App for Parents of Adolescents With Type 1 Diabetes-Pilot Study (T1DoingWell)
|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: NCT02877680|
Recruitment Status : Active, not recruiting
First Posted : August 24, 2016
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Behavioral: T1Doing Well||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Pilot of a Strengths-Based Behavioral mHealth Intervention to Promote Resilience in Adolescents With Type 1 Diabetes|
|Actual Study Start Date :||July 31, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.
Behavioral: T1Doing Well
Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors
No Intervention: Usual Care
Usual diabetes care and study-related data collection, without use of app during the study period. They will be offered an opportunity to try the app and share their feedback with the study team after completing follow-up data collection.
- Feasibility of Study Design [ Time Frame: 3-4 months after baseline ]Recruitment data will be used to calculate the percent of eligible families who enroll in the study. Usage data from the software platform will be used to calculate parent engagement with specific app features (e.g., response rate to prompts, frequency of opening feedback summaries, frequency of giving adolescent positive feedback) and the percent of participants who interact with any app feature at least twice weekly.
- Acceptability (survey) [ Time Frame: 3-4 months after baseline ]Post-intervention, participants will complete a validated measure of the users' perceived usefulness of, satisfaction with, and ease of use of a particular technology.
- Acceptability (interview) [ Time Frame: 3-4 months after baseline ]Semi-structured interviews with parents and adolescents will be conducted to contextualize survey responses, discuss experiences with the app (e.g., intrusiveness of prompts, clarity/relevance of response options, usefulness and appeal of strength behavior feedback charts), and obtain suggestions for improvement.
- Glycemic control [ Time Frame: 3-4 months after baseline ]Glycemic control (HbA1c) and blood glucose monitoring frequency are collected routinely at diabetes visits and will be extracted from the electronic medical record. Trained phlebotomists draw blood samples by fingerstick and analyze assays immediately using the DCA 2000 Hemoglobin HbA1c system (Siemens-Bayer).
- Adherence (objective) [ Time Frame: 3-4 months after baseline ]Glucometers are routinely downloaded and mean daily blood glucose monitoring frequency (previous 14 days) will be calculated.
- Adherence (self-report) [ Time Frame: 3-4 months after baseline ]Adolescents and parents will also each rate youth adherence to the diabetes regimen using the appropriate version (based on youth's insulin regimen) of the 24-item Diabetes Self-Management Profile Self-Report (DSMP-SR).
- Diabetes strengths [ Time Frame: 3-4 months after baseline ]Adolescents will self-report on the frequency of resilience-promoting attitudes and behaviors (i.e., strengths) via the Diabetes Strengths and Resilience measure (DSTAR), a 12-item measure of perceived mastery over T1D management demands and accessing social/family support for T1D needs.
- Diabetes-related family conflict [ Time Frame: 3-4 months after baseline ]Parents and youth will complete the Diabetes Family Conflict Scale Revised (DFCS-R), a 19-item scale of family conflict surrounding diabetes issues, which has good reliability and validity.
- Diabetes burden/distress [ Time Frame: 3-4 months after baseline ]Diabetes-specific burden will be assessed via the Problem Areas in Diabetes measures for adolescents (PAID-T, 26 items) and parents (PAID-PR, 18 items); both demonstrate good psychometric properties.
- Health-related quality of life [ Time Frame: 3-4 months after baseline ]Youth will complete the MIND-Youth Questionnaire (MY-Q), a 33-item measure of diabetes health-related QOL.
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): NCT02877680
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Marisa E Hilliard, PhD||Baylor College of Medicine and Texas Children's Hospital|