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Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT03921229
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
Johns Hopkins University
University of Kansas Medical Center
West Virginia University
Information provided by (Responsible Party):
Gregory Sawicki, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Behavioral: Tele-coaching Not Applicable

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.)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility, Acceptability, and Pilot Randomized Controlled Trial of a Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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).




Primary Outcome Measures :
  1. Patient attrition [ Time Frame: up to 30 months ]
    Patient attrition will be measured as the percentage of participants who do not receive a sufficient dose of the intervention.

  2. Intervention acceptability for patients assessed by Likert scale [ Time Frame: up to 30 months ]
    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.

  3. Intervention acceptability for coaches assessed by Likert scale [ Time Frame: up to 30 months ]
    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.

  4. Recruitment and feasibility [ Time Frame: up to 30 months ]
    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.


Secondary Outcome Measures :
  1. Mean change in global adherence [ Time Frame: Day 1 to approximately week 51 ]
    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.

  2. Change in treatment barriers [ Time Frame: Day 1 to approximately week 51 ]
    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.


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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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. Has access to technology, such as (a) mobile phone, tablet, computer, or digital camera capable of capturing and sending a digital image, and access to Internet; and (b) an email account;
  5. Is English-speaking; and
  6. Has a CF-CBS score of ≥ 3 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. Having a person in the same household who is also enrolled in the study;
  5. 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;
  6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921229


Contacts
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Contact: Jonathan Greenberg 617-355-3197 jonathan.greenberg@childrens.harvard.edu
Contact: Evelyn Bord 617-919-6154 evelyn.bord@childrens.harvard.edu

Locations
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United States, Colorado
National Jewish Health Not yet recruiting
Denver, Colorado, United States, 80206
Contact: Milene Saavedra, MD         
Contact: Katie Poch         
Principal Investigator: Milene Saavedra, MD         
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Michelle Prickett, MD         
Contact: Erin Lonergan         
Principal Investigator: Michelle Prickett, MD         
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Deepika Polineni, MD MPH         
Contact: Megan White         
Principal Investigator: Deepika Polineni, MD MPH         
United States, Missouri
Washington University School of Medicine in St Louis Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Peter Michelson, MD         
Contact: Lynn Henson         
Principal Investigator: Peter Michelson, MD         
United States, Texas
University of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Meghana Sathe, MD         
Contact: Casey Power         
Principal Investigator: Meghana Sathe, MD         
Principal Investigator: James Finklea, MD         
United States, West Virginia
West Virginia University Not yet recruiting
Morgantown, West Virginia, United States, 26506
Contact: Kathy Moffett, PhD         
Contact: Tammy Clark         
Principal Investigator: Kathy Moffett, PhD         
Sponsors and Collaborators
Boston Children’s Hospital
Cystic Fibrosis Foundation
Johns Hopkins University
University of Kansas Medical Center
West Virginia University
Investigators
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Principal Investigator: Deepika Polineni, MD, MPH University of Kansas Medical Center
Principal Investigator: Christina Duncan, PhD West Virginia University

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Responsible Party: Gregory Sawicki, Co-Chair of Success with Therapies Research Consortium, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03921229     History of Changes
Other Study ID Numbers: IRB-P00031836
STRC-109-16-02 ( Other Identifier: Success with Therapies Research Consortium )
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gregory Sawicki, Boston Children’s Hospital:
Patient Care
Tele-health
Behavioral intervention
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases