Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03921229|
Recruitment Status : Suspended (COVID pandemic)
First Posted : April 19, 2019
Last Update Posted : August 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Behavioral: Tele-coaching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2021|
|Estimated Study Completion Date :||December 2021|
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.
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).
- 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.
- 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.
- 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.
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
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Missouri|
|Washington University School of Medicine in St Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|United States, West Virginia|
|West Virginia University|
|Morgantown, West Virginia, United States, 26506|
|Principal Investigator:||Deepika Polineni, MD, MPH||University of Kansas Medical Center|
|Principal Investigator:||Christina Duncan, PhD||West Virginia University|