Feasibility, Acceptability, and Pilot Randomized Controlled Trial of a Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 12
- 主要终点
- Intervention acceptability for patients assessed by Likert scale
研究概览
简要总结
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.
详细描述
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.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COACH Participants:
- •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;
- •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.
排除标准
- •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:
- •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.
结局指标
主要结局
Intervention acceptability for patients assessed by Likert scale
时间窗: 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
时间窗: 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.
Patient attrition
时间窗: 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 coaches assessed by Likert scale
时间窗: 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.
次要结局
- Change in treatment barriers(Day 1 to approximately week 51)
- Mean change in global adherence(Day 1 to approximately week 51)
研究者
Gregory Sawicki
Co-Chair of Success with Therapies Research Consortium
Boston Children's Hospital