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

NCT02864641 | Completed Phase 2

• 2 other identifiers: 2R44DP003101 CKD2R44DP003101
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to test the efficacy of Planet K, a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' chronic kidney 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 K mobile app and website in improving treatment adherence, disease-related knowledge, transition readiness, condition management, and the psychological correlates of these variables in adolescents and young adults with chronic kidney disease (CKD).

Conditions

Renal Insufficiency, Chronic

Keywords

chronic kidney disease; adolescents; renal disease; CKD

Outcome Measures

Primary Outcomes (4)

• Knowledge of CKD

  Both parents and adolescent participants will complete a consultant-created 25 item questionnaire to assess their knowledge of CKD.

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

• End Stage Renal Disease-Adherence Questionnaire (ESRD-AQ)

  Both adolescent and parent participants will complete a modified version of the End Stage Renal Disease-Adherence Questionnaire (ESRD-AQ; Kim, Y., Evangelista, L.S., Phillips, L.R., Pavlish, C., \& Kopple, J.D., 2010). This 28-item measure assesses the extent to which youth adhere to the treatment plan put forth by their healthcare provider, including regular visits to the doctor, taking medications as prescribed, and following dietary recommendations. The parent version contains 22 items and the youth version contains 25 items.

  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

  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)

• Chronic Kidney Disease Self-Efficacy Instrument

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

• 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 Group: Planet K Treatment

EXPERIMENTAL

Participants in the TX Group will receive access to Planet K. 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. Adolescent and young adult participants will then receive a mobile phone preloaded with the Planet K app and a brief orientation to the app and associated website.

Behavioral: Planet K

CO Group: Treatment-as-usual

NO INTERVENTION

A national sample of CKD participants will be recruited. 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 K app and website but will receive email reminders to complete surveys online at each time point.

Interventions

Planet K BEHAVIORAL

Planet K is a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' chronic kidney 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 Group: Planet K Treatment

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Chronic Kidney Disease diagnosis

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

Renal Insufficiency, Chronic; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 12, 2016
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 12, 2016

Record last verified: 2016-08

Locations

US (1)