Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatment planet t1d
Phase phase 2
Sponsor 3-C Institute for Social Development
Start date July 2015
End date August 2016
Trial size 200 participants
Trial identifier NCT02861157, 2R44DP003101 Diabetes

Summary

The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops. Investigators will examine the effectiveness of the Planet T1D mobile app and website in improving treatment adherence, disease-related knowledge, transition readiness, condition management, and the psychological correlates of these variables in youth with type 1 diabetes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Families participating in the TX condition will be asked to attend a one-hour orientation session, during which study expectations and tasks will be explained. Families will be asked to watch a short 2-minute study overview video that summarizes study requirements and expectations. Parents and their children will then have the opportunity to provide informed consent/assent prior to their participation in the study. Youth participants will then receive a mobile phone preloaded with the Planet T1D app and a brief orientation to the app and associated website. Participants in the TX condition will receive immediate access to the Planet T1D application and website following the orientation session and will have four months to freely use the application. The TX group will be provided with a mobile phone for the full 2-months of the study.
planet t1d
Planet T1D is a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops.
(No Intervention)
A national sample of type 1 diabetes participants will be recruited through a partnership with Medikidz Ltd. Because of the inability to meet with remotely located participants for orientation and distribution of phones, these participants will be assigned to the treatment-as-usual, online control (CO) condition. For recruitment of the online control group, youth and parents interested in participating will be asked to complete a brief eligibility survey. Participants in the treatment-as-usual CO condition will not receive access to the Planet T1D app and website but will receive email reminders to complete surveys online at each time point.

Primary Outcomes

Measure
Knowledge of Type 1 Diabetes Disease
time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Diabetes Management Questionnaire (DMQ)
time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Perceived Treatment Benefits
time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
STARx Transition Readiness Questionnaire
time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change

Secondary Outcomes

Measure
Diabetes Self-Efficacy scale
time frame: Collected at two time points: pre-test and 2 months later at study completion to measure changetest
Self-Management: Self-Efficacy for Managing Chronic Disease Scale
time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Self-Management: Partners in Health Scale
time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Quality of Life
time frame: Collected at two time points: pre-test and 2 months later at study completion to measure change

Eligibility Criteria

Male or female participants from 12 years up to 17 years old.

Inclusion Criteria: - Type 1 Diabetes diagnosis - Between Ages of 12-17 years old

Additional Information

Official title Mobile Technology & Online Tools to Track Adherence in Chronic Illness Patients
Principal investigator Melanie Livet, PhD
Description Advances in medical treatment options over the past several decades have translated into substantially higher survival rates for those who suffer with chronic illness. Consequently, the prevalence of chronic illness has risen significantly in recent years, such that one out of every four youth in the United States currently lives with a chronic illness. The health and well-being of these youth is directly impacted by the degree to which they adhere to their treatment regimen. However, treatment regimens for chronic illness can be highly complex, making adherence problematic, particularly when combined with deficits in memory and executive functioning concomitant with many chronic illnesses. Adherence also tends to deteriorate over time; the youth's motivation or commitment to treatment may decline as symptoms improve or negative side effects occur. With low adherence comes worsening symptoms and significantly greater risk for serious medical complications and mortality in young adulthood. The costs associated with low adherence, such as the need for additional care, are also substantial both for the patient and society. While a number of factors have been found to impact treatment adherence, risk for non-adherence—across varied forms of chronic illness—is markedly elevated when the youth lacks disease- and treatment-related knowledge and when parents provide little supervision for carrying out regimen tasks. With nearly 90% of youth with chronic illness expected to survive and therefore transition from pediatric care into adult-focused healthcare systems, it is critically important to empower youth to take ownership of their own healthcare. To do so, we need to provide accessible, affordable tools that can effectively increase patients' skills and knowledge for managing their illness and support on-going adherence to their treatment regimen. The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops. Investigators will examine the effectiveness of the Planet T1D mobile app and website in improving treatment adherence, disease-related knowledge, transition readiness, condition management, and the psychological correlates of these variables in youth with type 1 diabetes. All participants will complete study measures at pre- and post-assessment time points. In total, participants will take part in this study for approximately 2 months from pre- to post-assessment. Families will be recruited to participate in either the treatment condition or the control group. Families in the treatment condition will receive the Planet T1D app and access to the associated website for the full duration of the study (2 months) between pre-test and post-test. Families in the control group will not receive access to the app and website, but instead will be asked to complete a series of online questionnaires at each of the two data collection time points (pre-test, post-test). Investigators hypothesize that greater use (i.e., dosage) and prolonged use of Planet T1D and access to the associated website will: increase disease-related knowledge, treatment adherence, self-efficacy for management of type 1 diabetes, current type 1 diabetes self-management behaviors, readiness to transition to independent self-care, and perceived benefits of type 1 diabetes treatment, while also decreasing perceived barriers to type 1 diabetes treatment. Moreover, investigators believe that improvement of these outcomes through use of Planet T1D will result in more positive mental health outcomes for patients, including higher reported quality of life. Investigators expect that those in the treatment condition will have better outcomes than those in the control group on all of these measures at both midpoint and post-assessment time points. Finally, investigators expect all participants to report high usability, quality, and value of the Planet T1D mobile app and website and to positively rate their experience with Planet T1D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by 3-C Institute for Social Development.