tele-coaching intervention to improve treatment adherence in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is a prospective, multicenter pilot study to investigate the feasibility and preliminary effectiveness of a tailored tele-coaching intervention to enhance medical adherence in patients with cf.

this is a prospective, multicenter pilot study to test the feasibility and acceptability of a tele-coaching intervention and its implementation in patients with cf (ages 14-25 years), and to obtain estimates of treatment effects across a range of key outcome measures (e.g., global adherence, change in treatment barriers, specific improvement in adherence, etc.)

Eligibility criteria:
inclusion criteria: coach participants: 1. be a cf-focused clinician employed by one of the study sites, including: social workers; respiratory therapists, pharmacists, nurse practitioners, nurses, mental health coordinators, dieticians, and psychologists. patient participants: 1. male or female ≥ 14 and ≤ 25 years of age; 2. documentation of a cf diagnosis as evidenced by one or more clinical features consistent with the cf phenotype and one or more of the following criteria: (a) sweat chloride \> 60 meq/l by quantitative pilocarpine iontophoresis test (qpit), and/or (b) two well-characterized mutations in the cftr (cystic fibrosis transmembrane conductance regulator) gene; 3. has been prescribed one or more respiratory nebulized medications, such as: (a) dornase alfa, (b) hypertonic saline, (c) inhaled tobramycin, (d) inhaled aztreonam, (e) inhaled colistimethate \*and/or\* uses a vest device for airway clearance; 4. if taking, or anticipating to start on, trikafta, has been taking the modulator for 6 weeks prior to enrolling in the study; 5. has access to necessary resources for participating in a technology-based intervention: (a) mobile phone, tablet, computer, or digital camera capable of capturing and sending a digital image, and access to internet; (b) an email account; 6. is english-speaking; 7. endorsed score of ≥3 on any treatment component on the cf-cbs at enrollment visit. caregiver participants: 1. is a caregiver of and resides with a patient participant in this study; 2. has received permission from the patient participant, if aged 18 years of age or older, to be in the study; and 3. is english-speaking. exclusion criteria: coach participants: 1. anticipated change in cf center during study period; 2. physicians (md, do, or equivalent degree); 3. advanced practice providers (e.g., aprn, pa) who serve as the primary provider in the cf clinic setting; and 4. site research coordinator designated for this study. patient participants: 1. participation in the previous tele-coaching study; 2. anticipated transition to another cf care center within study period; 3. planned or scheduled hospitalization between consent and start of intervention; 4. self-reported current or planned pregnancy; 5. having a person in the same household who is also enrolled in the study; 6. presence of a condition, abnormality, or other factor that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data including, but not limited to: (a) diagnosis of intellectual or developmental disability that would preclude safe or adequate completion of measures; (b) history of, or planned, lung transplant; 7. participation in concurrent studies targeting improvement in treatment adherence. caregiver participants: 1. participation in the previous tele-coaching study; 2. only one caregiver per patient participant can be enrolled in the caregiver cohort.

Keywords: patient care tele-health behavioral intervention