Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

NCT03921229 | Completed

• 2 other identifiers: IRB-P00031836STRC-109-16-02
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 6

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.

Conditions

Cystic Fibrosis

Keywords

Patient Care; Tele-health; Behavioral intervention

Outcome Measures

Primary Outcomes (4)

• Patient attrition

  Patient attrition will be measured as the percentage of participants who do not receive a sufficient dose of the intervention.

  up to 30 months

• Intervention acceptability for patients assessed by Likert scale

  This measure was developed for this specific study to evaluate feasibility and acceptability of the intervention through aspects of usability, quality, and satisfaction. Assessed by 5 point Likert Scale: Strongly disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree.

  up to 30 months

• Intervention acceptability for coaches assessed by Likert scale

  This measure was developed for this specific study to evaluate feasibility and acceptability of the intervention through aspects of usability, quality, and satisfaction. Assessed by 5 point Likert Scale: Strongly disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree.

  up to 30 months

• Recruitment and feasibility

  Recruitment and feasibility will be evaluated using the percentage of screen failures which are the number of eligible participants who do not score at least a three on any given treatment component for the CF-CBS amongst all eligible participants.

  up to 30 months

Secondary Outcomes (2)

• Mean change in global adherence

  Day 1 to approximately week 51

• Change in treatment barriers

  Day 1 to approximately week 51

Other Outcomes (1)

• Exploratory outcome: self-reported adherence

  Day 1 to approximately week 51

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Tele-coaching

Interventions

Tele-coaching 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).

Intervention

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• COACH Participants:
• \. 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:
• Male or female ≥ 14 and ≤ 25 years of age;
• 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;
• 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;
• If taking, or anticipating to start on, Trikafta, has been taking the modulator for 6 weeks prior to enrolling in the study;
• 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;
• Is English-speaking;
• Endorsed score of ≥3 on any treatment component on the CF-CBS at Enrollment Visit.
• CAREGIVER Participants:
• Is a caregiver of and resides with a Patient Participant in this study;
• Has received permission from the Patient Participant, if aged 18 years of age or older, to be in the study; and
• Is English-speaking.

You may not qualify if:

• COACH Participants:
• Anticipated change in CF Center during study period;
• Physicians (MD, DO, or equivalent degree);
• Advanced practice providers (e.g., APRN, PA) who serve as the primary provider in the CF clinic setting; and
• Site research coordinator designated for this study.
• PATIENT Participants:
• Participation in the previous Tele-coaching study;
• Anticipated transition to another CF care center within study period;
• Planned or scheduled hospitalization between consent and start of intervention;
• Self-reported current or planned pregnancy;
• Having a person in the same household who is also enrolled in the study;
• 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;
• Participation in concurrent studies targeting improvement in treatment adherence.
• CAREGIVER Participants:
• Participation in the previous Tele-coaching study;

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Cystic Fibrosis Foundation: collaborator
• Johns Hopkins University: collaborator
• University of Kansas Medical Center: collaborator
• West Virginia University: collaborator

Study Sites (6)

Stanford University

Palo Alto, California, 94305, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

• Deepika Polineni, MD, MPH

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Christina Duncan, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Chair of Success with Therapies Research Consortium

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 19, 2019
• Study Start: January 13, 2020
• Primary Completion: January 31, 2023
• Study Completion: February 1, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)