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

NCT02861157 | Completed Phase 2

• 2 other identifiers: 2R44DP003101 Diabetes2R44DP003101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes; Adolescents; T1D

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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 Outcomes (4)

• Diabetes Self-Efficacy scale

  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

  Collected at two time points: pre-test and 2 months later at study completion to measure change

• Self-Management: Partners in Health Scale

  Collected at two time points: pre-test and 2 months later at study completion to measure change

• Quality of Life

  Collected at two time points: pre-test and 2 months later at study completion to measure change

Study Arms (2)

TX Condition: Planet T1D Intervention

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.

Behavioral: Planet T1D

CO Condition: Treatment-As-Usual

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.

Interventions

Planet T1D BEHAVIORAL

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.

TX Condition: Planet T1D Intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• 3-C Institute for Social Development: lead

Study Sites (1)

3-C Institute for Social Development

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Melanie Livet, PhD

  3-C Institute for Social Development

  PRINCIPAL INVESTIGATOR

• Janey McMillen, PhD

  3-C Institute for Social Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 10, 2016
• Study Start: July 1, 2015
• Primary Completion: September 12, 2016
• Study Completion: September 12, 2016
• Last Updated: January 30, 2017

Record last verified: 2017-01

Locations

US (1)