Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

Feasibility, Acceptability, and Pilot Randomized Controlled Trial of a Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Tele-coaching

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.)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in global adherence	Assess the preliminary effect of intervention on treatment adherence from data collected from vest photo capture and eTrack nebulizers. Vest photo capture will be scored as a ratio of total minutes used to total minutes prescribed in the study period. Medication adherence will be scored as a 'per drug analysis' of adherence with a ratio of competed to total prescribed doses in the study period. A composite score will be determined based on prescribed medications and medication/doses taken.	Day 1 to approximately week 51
Change in treatment barriers	The CF-CBS (Cystic Fibrosis Care Behaviors Survey) will be used to analyze barriers to treatment. Measure will be based on an overall decrease (difference in means) in barrier specific frequency, specific treatment total barriers and the composite score for barriers from pre-intervention to post-intervention.	Day 1 to approximately week 51

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome: self-reported adherence	We will compare the Self-Reported Adherence measure and the CF-CBS Self-Reported Adherence using Pearson Correlations.	Day 1 to approximately week 51

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Johns Hopkins University; University of Kansas Medical Center; Cystic Fibrosis Foundation; West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Behavioral intervention; Patient Care; Tele-health
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: IRB-P00031836; STRC-109-16-02 (Other Identifier: Success with Therapies Research Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No