Clinical trial NCT03052231: Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center
Official title: Evaluating the Feasibility of Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Cystic Fibrosis
Keywords: adherence
cystic fibrosis
Lead sponsor: Landon Pediatric Foundation
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2017-02-14
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This study will evaluate the effectiveness of an interactive mobile health information service in supporting clinic staff (i.e., nurse practitioners, case managers and care coordinators) at a Cystic Fibrosis Center clinic to connect with patients and create conversations around behavior-centered goals. The interactive mobile health information service has been designed to supplement the standard of care by supporting patient-empowerment strategies through:

* educating participants,
* encouraging behavior change, and
* promoting adherence with their treatment protocols.

The project will adapt the iCAN program content as an educational tool to be incorporated in the educational material. iCAN is an electronic platform aimed to provide an engaging environment for diabetic outpatients to self-manage, gain control over their health, and ultimately adhere to their medical appointments and regimen. Similar to diabetes, CF is an all-encompassing chronic disease that requires coordinated efforts among patients, caregivers, and health-care providers across treatment adherence, nutrition, lifestyle choices, and social support systems. 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. While a number of technically sophisticated applications exist, our approach will involve a less sophisticated and complex approach. Our primary objective is to get the information to the patients, some of whom are members of lower income minority communities. If "simple" interventions prove effective, then the groundwork will have been laid for considering more tailored albeit complex systems.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Scheduled appointments attended
timeFrame: Six months
Secondary outcomes:
measure: Knowledge of disease Questionnaire
timeFrame: Six Months
measure: FEV1 in LPM
timeFrame: 6 months
measure: Body mass index
timeFrame: six months
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Pediatric Diagnostic Center
state: California
Study officials:
affiliation: Landon Pediatric Foundation
name: Chris Landon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Quittner A et al. Chest 2011 (4_MeetingAbstracts):908A
citation: Imperial College of London. iCAN Self---Management Technology: Helping Patients to Medical Appointments. CID 00884448, May 5, 2014
citation: 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.
citation: 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.
citation: QSR International, Victoria, Australia, 2015