Cystic FibrosisNCT03921229
Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis
A study testing Tele-coaching in people with Cystic Fibrosis, run by Boston Children's Hospital at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Tele-coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Jan 2020to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northwestern University
Chicago, Illinois, 60611
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
University of Kansas Medical Center
Kansas City, Kansas, 66160
West Virginia University
Morgantown, West Virginia, 26506
Stanford University
Palo Alto, California, 94305
About this study
Official title: 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.
Read the 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.)
- Conditions
- Cystic Fibrosis
- Being tested
- Tele-coaching
- Keywords
- Patient Care, Tele-health, Behavioral intervention
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-coachingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tele-coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient attrition
Patient attrition will be measured as the percentage of participants who do not receive a sufficient dose of the intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 30 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 1 to approximately week 51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start13 Jan 2020
- Primary completion31 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Johns Hopkins University, University of Kansas Medical Center, West Virginia University
- Responsible party
- Principal investigator, Gregory Sawicki, Boston Children's Hospital
- Investigators
- Deepika Polineni, MD, MPH, Principal investigator, University of Kansas Medical CenterChristina Duncan, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921229
- Sponsor's protocol ID
- IRB-P00031836
- Other IDs
- STRC-109-16-02
- Status last verified
- Mar 2023
- First submitted
- 4 Apr 2019
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lindwall JJ, Muther EF, Ford C, Bord E, Green A, Polineni D, Naranjo D, Duncan CL. A feasibility pilot trial to deliver a virtual intervention for promoting daily self-management in adolescents and young adults with cystic fibrosis: A brief report of tele-coach outcomes. PEC Innov. 2026 Jun 1;9:100481. doi: 10.1016/j.pecinn.2026.100481. eCollection 2026 Dec.
PubMed 42305635
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Pilot Randomized Controlled Trial of a Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03921229
- Acronym / sponsor ID
- IRB-P00031836
- Conditions
- Cystic Fibrosis
- Keywords
- Patient Care, Tele-health, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Johns Hopkins University, University of Kansas Medical Center, West Virginia University
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Tele-coaching6-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. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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.
- 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;
Key exclusion criteria (16 listed)
- 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.
- Participation in the previous Tele-coaching study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-coachingPatients 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). | Behavioural | Intervention |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Mean change in global adherence
Time frame: Day 1 to approximately week 51
Change in treatment barriers
Time frame: Day 1 to approximately week 51
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Derived from this study: PubMed 42305635Lindwall JJ, Muther EF, Ford C, Bord E, Green A, Polineni D, Naranjo D, Duncan CL. A feasibility pilot trial to deliver a virtual intervention for promoting daily self-management in adolescents and young adults with cystic fibrosis: A brief report of tele-coach outcomes. PEC Innov. 2026 Jun 1;9:100481. doi: 10.1016/j.pecinn.2026.100481. eCollection 2026 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepika Polineni, MD, MPH principal investigator
University of Kansas Medical Center
Christina Duncan, PhD principal investigator
West Virginia University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-coaching in people with Cystic Fibrosis, run by Boston Children's Hospital at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient attrition (time frame: up to 30 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03921229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.