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出境医 / 临床实验 / Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

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
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.)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : January 13, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 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 [ 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.


Eligibility Criteria
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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.
Contacts and Locations

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 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
Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date March 12, 2021
Actual Study Start Date  ICMJE January 13, 2020
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Patient Engagement [ Time Frame: up to 30 months ]
    This measure will be used to evaluate feasibility and acceptability of the intervention in relation to participating patients. Measured as ratio of participants who completed each session to total enrolled by each group. This will be combined with patient withdrawals to report Patient Attrition score.
  • Patient Withdrawals [ Time Frame: up to 30 months ]
    This measure will be used to evaluate feasibility and acceptability of the intervention in relation to participating patients. Measured as ratio of number withdrawn to total number enrolled by each group. This will be combined with Patient Engagement to report Patient Attrition score.
  • Patient concordance to scheduled intervention [ Time Frame: up to 30 months ]
    This measure will be used to evaluate feasibility and acceptability of the intervention in relation to participating patients. Average concordance will be measured as ratio of total number of days to total number of sessions. Averages of sessions within and outside window will also be calculated. Averages will be combined with the Homework Completion Score to report Patient Fidelity score.
  • Homework Completion Score [ Time Frame: up to 30 months ]
    This measure will be used to evaluate feasibility and acceptability of the intervention in relation to participating patients. Intervention homework worksheets will be scored on a 0-4 scale. Completion score will be calculated as the ratio of homework ratings (0-4) total across sessions to the number of sessions with assigned homework.
  • Coach Attrition [ Time Frame: up to 30 months ]
    This measure will be used to evaluate feasibility and acceptability of the intervention in relation to coach participants. Attrition will be measured as the ratio of the number of coaches who withdrew to the total number enrolled.
  • Coach concordance to scheduled intervention [ Time Frame: up to 30 months ]
    This measure will be used to evaluate feasibility and acceptability of the intervention in relation to coach participants. Average concordance will be measured as a ratio of the total number of days to the total number of sessions. Averages of sessions within and outside window will also be calculated. Averages will be combined with the Coach Session Integrity to report Coach Fidelity score.
  • Coach Session Integrity [ Time Frame: up to 30 months ]
    This measure will be used to evaluate feasibility and acceptability of the intervention in relation to coach participants. Session integrity will be measured by percent fidelity to session integrity checklist. Average total percent fidelity across coaches, as well as percent fidelity for each coach will be measured. This will be combined with Coach concordance to scheduled intervention to report Coach Fidelity score.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • 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 calculated by the pre/post difference in composite score.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: September 4, 2019) 		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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis
Official Title  ICMJE Feasibility, Acceptability, and Pilot Randomized Controlled Trial of a Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE 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).
Study Arms  ICMJE 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.
Intervention: Behavioral: Tele-coaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jonathan Greenberg 617-355-3197 jonathan.greenberg@childrens.harvard.edu
Contact: Evelyn Bord 617-919-6154 evelyn.bord@childrens.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921229
Other Study ID Numbers  ICMJE IRB-P00031836
STRC-109-16-02 ( Other Identifier: Success with Therapies Research Consortium )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gregory Sawicki, Boston Children's Hospital
Study Sponsor  ICMJE Boston Children's Hospital
Collaborators  ICMJE
  • Cystic Fibrosis Foundation
  • Johns Hopkins University
  • University of Kansas Medical Center
  • West Virginia University
Investigators  ICMJE
Principal Investigator: Deepika Polineni, MD, MPH University of Kansas Medical Center
Principal Investigator: Christina Duncan, PhD West Virginia University
PRS Account Boston Children's Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP