Clinical trial NCT03921229: Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis
Official title: Feasibility, Acceptability, and Pilot Randomized Controlled Trial of a Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Patient Care
Tele-health
Behavioral intervention
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
name: Johns Hopkins University
name: University of Kansas Medical Center
name: West Virginia University
First posted: 2019-04-19
Enrollment: 31
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Patient attrition
timeFrame: up to 30 months
measure: Intervention acceptability for patients assessed by Likert scale
timeFrame: up to 30 months
measure: Intervention acceptability for coaches assessed by Likert scale
timeFrame: up to 30 months
measure: Recruitment and feasibility
timeFrame: up to 30 months
Secondary outcomes:
measure: Mean change in global adherence
timeFrame: Day 1 to approximately week 51
measure: Change in treatment barriers
timeFrame: Day 1 to approximately week 51
Other outcomes:
measure: Exploratory outcome: self-reported adherence
timeFrame: Day 1 to approximately week 51
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Kansas Medical Center
name: Deepika Polineni, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University
name: Christina Duncan, PhD
role: PRINCIPAL_INVESTIGATOR
References: