Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center

NCT03052231 | Completed

• 1 other identifier: LandonPF
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Programs to enhance adherence, including comprehensive behavioral interventions with adolescents, have met with mixed success. Advances in therapy, treatment delivery systems, and data capture technology offer the potential for enhancing adherence by providing immediate and more frequent feedback to the patient regarding his or her fidelity to the prescribed treatment regimen. The investigators propose to evaluate a systematic yet technically simple approach to linking treatment and feedback components to enhance adherence in a real-work CF clinic setting that treats a significant minority patient population. This is the first trial assessing the impact of a collaborative active intervention program of a multi disciplinary team in improving adherence to specific chronic medications and improving clinical outcomes in CF patients. The PI has implemented the texting service (Caremessage.org) with COPD and diabetes patients. The content will be modified to provide both English and Spanish language content relevant to these participants and their standard treatment protocols.

Conditions

Medication Adherence; Cystic Fibrosis

Keywords

adherence; cystic fibrosis

Outcome Measures

Primary Outcomes (1)

• Number of Scheduled appointments attended

  Secondary objectives include evaluating program processes that enhance participant use of the system: 1) to receive responses to specific questions; 2) to track their individual progress towards achieving health goals, and; 3) to respond to system prompts to self-report data in the interactive component related to their actions or behaviors, e.g. RSVP to appointment reminders, self-management behaviors related to medication adherence, and self-management behaviors related to the achieving health goals. Processes involving program management and impact on barriers to treatment delivery by clinic staff, treating physicians and parents will also be evaluated.

  Six months

Secondary Outcomes (3)

• Knowledge of disease Questionnaire

  Six Months

• FEV1 in LPM

  6 months

• Body mass index

  six months

Study Arms (2)

Interactive Mobile Health Information

ACTIVE COMPARATOR

Receives Interactive Mobile Health Information via caremessage. EAI staff focus group content will include qualitative descriptions of their experiences with training and actual use of the Caremessages.org service, as well as to elicit comments about contributing features and other mitigating or enhancing factors of the intervention's implementation, outreach and promotion, and integration into workflow practices.

Device: caremessage

Usual care

NO INTERVENTION

Usual care - clinic education, medication refills without reminders, appointments without reminders

Interventions

caremessage DEVICE

Central to the mobile health information service is the interactive and personalized text-based message system that delivers actionable and tailored health content to participants: office visit appointment reminders; medication adherence reminders; and general health education messages.

Interactive Mobile Health Information

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosis of Cystic fibrosis at all ages;
• Their associated CF Center professionals;
• Their associated family;
• CF patients that should be treated with one or more of these chronic medications: Tobi (Tobramycin), (Colistin), Pulmozyme (Dornase Alpha), Hypertonic Saline (HS), Creon (pancreatic enzymes), AquaADEKs (Multivitamin);
• Patients willing to participate in a trial;
• Presence of a parent/guardian capable of providing informed consent; and
• Patients attending CF clinic at least once every 12 months.

You may not qualify if:

• Absence of a parent/guardian or unwillingness to provide permission;
• Potential participant declines to provide assent; and
• Transplant patients.

Sponsors & Collaborators

• Landon Pediatric Foundation: lead
• AbbVie: collaborator

Study Sites (1)

Pediatric Diagnostic Center

Ventura, California, 93003, United States

Location

Related Publications (6)

• Eakin MN, Bilderback A, Boyle MP, Mogayzel PJ, Riekert KA. Longitudinal association between medication adherence and lung health in people with cystic fibrosis. J Cyst Fibros. 2011 Jul;10(4):258-64. doi: 10.1016/j.jcf.2011.03.005. Epub 2011 Mar 31.

  PMID: 21458391 BACKGROUND

• Quittner A et al. Chest 2011 (4_MeetingAbstracts):908A

  BACKGROUND

• Imperial College of London. iCAN Self---Management Technology: Helping Patients to Medical Appointments. CID 00884448, May 5, 2014

  BACKGROUND

• Modi AC, Lim CS, Yu N, Geller D, Wagner MH, Quittner AL. A multi-method assessment of treatment adherence for children with cystic fibrosis. J Cyst Fibros. 2006 Aug;5(3):177-85. doi: 10.1016/j.jcf.2006.03.002. Epub 2006 May 5.

  PMID: 16679071 BACKGROUND

• Taddeo D, Egedy M, Frappier JY. Adherence to treatment in adolescents. Paediatr Child Health. 2008 Jan;13(1):19-24. doi: 10.1093/pch/13.1.19.

  PMID: 19119348 BACKGROUND

• QSR International, Victoria, Australia, 2015

  BACKGROUND

MeSH Terms

Conditions

Medication Adherence; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Chris Landon, MD

  Landon Pediatric Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: February 14, 2017
• Study Start: March 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)