Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

Study Overview
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Brief Summary
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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
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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.)

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Tele-coaching


Participation Criteria
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Eligibility Criteria
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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: 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. Exclusion Criteria: 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; Only one caregiver per Patient Participant can be enrolled in the Caregiver Cohort.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Care, Tele-health, Behavioral intervention