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| ID | Type | Description | Link |
|---|---|---|---|
| STRC-109-16-02 | Other Identifier | Success with Therapies Research Consortium |
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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
| Johns Hopkins University | OTHER |
| University of Kansas Medical Center | OTHER |
| West Virginia University |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-coaching | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient attrition | Patient attrition will be measured as the percentage of participants who do not receive a sufficient dose of the intervention. | 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. | 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. | 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. | up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcome: self-reported adherence | We will compare the Self-Reported Adherence measure and the CF-CBS Self-Reported Adherence using Pearson Correlations. | Day 1 to approximately week 51 |
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:
CAREGIVER Participants:
Exclusion Criteria:
COACH Participants:
PATIENT Participants:
CAREGIVER Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Deepika Polineni, MD, MPH | University of Kansas Medical Center | Principal Investigator |
| Christina Duncan, PhD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States | ||
| National Jewish Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42305635 | Derived | 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. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| OTHER |
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| 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. | Day 1 to approximately week 51 |
| Denver |
| Colorado |
| 80206 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |