Mobile Technology & Online Tools to Track Adherence in Chronic Illness Patients (OMMS)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: Planet T1D

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • 3-C Institute for Social Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TX Condition: Planet T1D Intervention; 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.	Behavioral: 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: CO Condition: Treatment-As-Usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Treatment Benefits	Both adolescents and their parents will report on their perceptions of the benefits and barriers of adherence to the condition treatment regimen. This measure was adapted from the Beliefs about Dietary Compliance scale (BDCS; Bennett et al, 2001) and contains 9 items on both the parent and youth versions.	Collected at two time points: pre-test and 2 months later at study completion to measure change
Knowledge of Type 1 Diabetes Disease	Both parent and adolescent participants will complete a consultant-created 25 item questionnaire to assess their knowledge of type 1 diabetes.	Collected at two time points: pre-test and 2 months later at study completion to measure change
Diabetes Management Questionnaire (DMQ)	Both adolescent and parent participants will complete a modified version of the Diabetes Management Questionnaire (DMQ; Mehta, Nansel, Volkening, Butler, Haynie and Laffel, 2015). This 20-item measure assesses treatment adherence behaviors to help regulate blood sugar.	Collected at two time points: pre-test and 2 months later at study completion to measure change
STARx Transition Readiness Questionnaire	Adolescents will complete the STARx Transition Readiness Questionnaire. This 18-item measure assesses the extent to which youth are ready to transition to independent care and manage their health-related needs independently. Items assess adolescents' independence in scheduling doctor's appointments, remembering to take medication, finding answers to health-related questions, knowledge of their condition, and how easy/difficult these tasks are for the youth.	Collected at two time points: pre-test and 2 months later at study completion to measure change

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Adolescents will complete a subset of 19 items from the Kidney Disease and Quality of Life-Short Form (KDQOL-SF; Hays et al., 1997). Items were modified to be more general and applicable to any medical condition. These items comprise subscales that assess patients' symptoms, burden of condition in interfering with life, cognitive functioning, social support, and difficulty sleeping.	Collected at two time points: pre-test and 2 months later at study completion to measure change
Diabetes Self-Efficacy scale	Adolescents will complete the 8-item Diabetes Self-Efficacy scale (Lorig K, Ritter PL, Villa FJ, 2009). This measure assesses patients' self-confidence in managing their condition, including self-confidence in (a) managing the disease autonomously, (b) knowing how to handle diabetes-related problems, and (c) practicing dietary behaviors necessary for blood sugar control.	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	The measure is composed of the 6-item Self-Efficacy for Managing Chronic Disease scale (Ritter & Lorig, 2015), assessing confidence in self-management ability.	Collected at two time points: pre-test and 2 months later at study completion to measure change
Self-Management: Partners in Health Scale	Partners in Health scale (Cordova et al. 2013), a 11 item measure assessing ability to observe and manage symptoms.	Collected at two time points: pre-test and 2 months later at study completion to measure change

Collaborators and Investigators

• Sponsor: 3-C Institute for Social Development
• Investigators: Principal Investigator: Melanie Livet, PhD, 3-C Institute for Social Development; Principal Investigator: Janey McMillen, PhD, 3-C Institute for Social Development

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): September 12, 2016
• Study Completion (Actual): September 12, 2016

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Adolescents; Type 1 Diabetes; T1D
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Diabetes Mellitus, Type 1; Chronic Disease
• Other Study ID Numbers: 2R44DP003101 Diabetes; 2R44DP003101 (U.S. NIH Grant/Contract)