Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

NCT ID: NCT03921229

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2023-02-01

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.)

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

6-months of 11 web-based intervention (tele-coaching) sessions (9 biweekly sessions and 2 monthly sessions) of approximately 30 minutes each; continued use of eTrack nebulizer and vest monitor photo capture as measures of adherence.

Group Type: EXPERIMENTAL

Tele-coaching

Intervention Type: BEHAVIORAL

Patients will meet with a "tele-coach," who is a care team member, via video-calling, on a regular basis for six months to identify and address treatment adherence concern(s).

Interventions

Tele-coaching

Patients will meet with a "tele-coach," who is a care team member, via video-calling, on a regular basis for six months to identify and address treatment adherence concern(s).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gregory Sawicki

Co-Chair of Success with Therapies Research Consortium

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepika Polineni, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Christina Duncan, PhD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

Stanford University

Palo Alto, California, United States

National Jewish Health

Denver, Colorado, United States

Northwestern University

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

STRC-109-16-02

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-P00031836

Identifier Type: -

Identifier Source: org_study_id