Clinical trial NCT02861157: Mobile Technology & Online Tools to Track Adherence in Chronic Illness Patients
Official title: Mobile Technology & Online Tools to Track Adherence in Chronic Illness Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 Diabetes
Adolescents
T1D
Lead sponsor: 3-C Institute for Social Development
Sponsor class: INDUSTRY
First posted: 2016-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes diagnosis
* Between Ages of 12-17 years old

Primary outcomes:
measure: Knowledge of Type 1 Diabetes Disease
timeFrame: Collected at two time points: pre-test and 2 months later at study completion to measure change
measure: Diabetes Management Questionnaire (DMQ)
timeFrame: Collected at two time points: pre-test and 2 months later at study completion to measure change
measure: Perceived Treatment Benefits
timeFrame: Collected at two time points: pre-test and 2 months later at study completion to measure change
measure: STARx Transition Readiness Questionnaire
timeFrame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Secondary outcomes:
measure: Diabetes Self-Efficacy scale
timeFrame: Collected at two time points: pre-test and 2 months later at study completion to measure changetest
measure: Self-Management: Self-Efficacy for Managing Chronic Disease Scale
timeFrame: Collected at two time points: pre-test and 2 months later at study completion to measure change
measure: Self-Management: Partners in Health Scale
timeFrame: Collected at two time points: pre-test and 2 months later at study completion to measure change
measure: Quality of Life
timeFrame: Collected at two time points: pre-test and 2 months later at study completion to measure change
Other outcomes:
Locations:
city: Durham
country: United States
facility: 3-C Institute for Social Development
state: North Carolina
Study officials:
affiliation: 3-C Institute for Social Development
name: Melanie Livet, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 3-C Institute for Social Development
name: Janey McMillen, PhD
role: PRINCIPAL_INVESTIGATOR
References: