Feasibility of a Mobile Medication Plan Application in CF Patient Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 10
- 主要终点
- mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients assessed by likert scale
研究概览
简要总结
This is a pilot, multicenter, prospective, randomized controlled study to evaluate the feasibility of an innovative medication adherence intervention utilizing a web-based, mobile medication management application [MedActionPlan® (MAP)] to encourage self-management by reinforcing adherence and education about treatment regimens in Participants with cystic fibrosis (CF) (ages 12 years and older).
Outcomes of interest for this study are 1) feasibility of MAP in real-world setting which will be evaluated using patient/caregiver and clinician feedback regarding value, ease of use, and challenges with use, 2) effect of MAP on patient/caregiver knowledge and perception of medication use, 3) effect of MAP on adherence to inhaled and oral medications used in chronic management of CF. Preliminary data regarding outcomes on exacerbations, lung function, and health care system utilization (e.g., emergency department visits, hospitalization) will also be examined as part of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CLINICIAN PARTICIPANTS:
- •A CF care team member from any discipline, designated by the site principal investigator (PI) and CF team
- •Willing to use MAP as part of CF care
- •PATIENT PARTICIPANTS:
- •Male or female patients ages ≥ 12 years of age at Study Visit 1
- •Documentation of a CF diagnosis (physician diagnosed)
- •Ability to understand verbal and written English
- •Access to mobile device such as a tablet or smartphone (iPhone/iPad/iTouch or Android device)
- •Willingness to use the MAP application
- •Currently taking at least one of the following chronic medications and willing to use AdhereTech pill bottles for oral medications and/or eTrack nebulizer for nebulized medications listed below: nebulized agents, dornase alfa, hypertonic saline, inhaled tobramycin, inhaled aztreonam, inhaled colistimethate, oral agents, azithromycin
- •CAREGIVER PARTICIPANTS (for Patient Participants age < 18 years)
- •Child is consented to participate in the study.
- •Ability to understand verbal and written English
排除标准
- •CLINICIAN PARTICIPANTS:
- •Previous use of MAP (with patient(s) or self) in the last 12 months - when used with patients, defined as use in 5 or more patients
- •PATIENT PARTICIPANTS:
- •Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in own care
- •Presence of a condition or abnormality 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, diagnosis of intellectual or developmental disability (e.g., autism); and/or history of lung transplant
- •Planned or scheduled hospitalization during study period of up to 36 weeks
- •CAREGIVER PARTICIPANTS:
- •(for Patient Participants age < 18 years)
- •Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in child's or own care
结局指标
主要结局
mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients assessed by likert scale
时间窗: week 24
This measure was developed for this specific study to evaluate feasibility and acceptability of patient use through aspects of usability and quality (engagement, usefulness, functionality/ease of use, aesthetics, information, and satisfaction) of the web portal and application. Assessed by 5 point Likert Scale: Strongly disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree
mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for clinicians 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 clinician use through aspects of usability and quality (engagement, usefulness, functionality/ease of use, aesthetics, information, and satisfaction) of the web portal and application. Assessed by 5 point Likert Scale: Strongly disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree
次要结局
- change in CF Medication Questionnaire (CF-MQ) scores(Day 1 to approximately week 24)
- change in Knowledge of Disease Management-CF questionnaire (KDM-CF) scores(Day 1 to approximately week 24)
- change in CF Medication Belief Questionnaire (CF-MBQ) scores(Day 1 to approximately week 24)
- Mean change in adherence(Day 1 to approximately week 24)
研究者
Gregory Sawicki
Co-Chair of Success with Therapies Research Consortium
Boston Children's Hospital