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Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

Sponsor
Boston Children's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03921229
Collaborator
Cystic Fibrosis Foundation (Other), Johns Hopkins University (Other), University of Kansas Medical Center (Other), West Virginia University (Other)
31
Enrollment
6
Locations
1
Arm
34.6
Anticipated Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Tele-coaching
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
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
Actual Study Start Date :
Jan 13, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Patient attrition [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 [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 [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 [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 [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 [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 [Day 1 to approximately week 51]

    We will compare the Self-Reported Adherence measure and the CF-CBS Self-Reported Adherence using Pearson Correlations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Palo Alto California United States 94305
2 National Jewish Health Denver Colorado United States 80206
3 Northwestern University Chicago Illinois United States 60611
4 University of Kansas Medical Center Kansas City Kansas United States 66160
5 University of Texas Southwestern Medical Center Dallas Texas United States 75390
6 West Virginia University Morgantown West Virginia United States 26506

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Deepika Polineni, MD, MPH, University of Kansas Medical Center
  • Principal Investigator: Christina Duncan, PhD, West Virginia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gregory Sawicki, Co-Chair of Success with Therapies Research Consortium, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT03921229
Other Study ID Numbers:
  • IRB-P00031836
  • STRC-109-16-02
First Posted:
Apr 19, 2019
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gregory Sawicki, Co-Chair of Success with Therapies Research Consortium, Boston Children's Hospital
Patient Care
Tele-health
Behavioral intervention
Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis

Study Results

No Results Posted as of Mar 29, 2022