Improving Adherence and Clinical Outcome in Cystic Fibrosis (CF) Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of a collaborative active intervention
      program of a multi-disciplinary team on improving adherence to chronic medications and
      improve clinical outcomes in CF patients.
    

Detailed description: 
      Cystic fibrosis is a life-threatening hereditary multi-system disease predominantly affecting
      the pancreas and lungs. Advances in treatment have led to significant improvements in
      prognosis though this depends crucially upon adherence to treatment.

      It has been demonstrated in chronic conditions that improving medication adherence can
      improve clinical outcome, though it can be a difficult and complex task.

      This is the first trial assessing the impact of a collaborative active intervention program
      of a multi disciplinary team in improving adherence to specific chronic medications and
      improving clinical outcomes in CF patients.

      The trial will be divided into two parts:

      First Part The first part of the trial will be a retrospective one in which data will be
      collected at baseline, from eligible patient files and patients' pharmacy records receiving
      standard care for the past 12 months.

      Second Part The second part of the trial will be an active interventional prospective one and
      will be conducted for 12 months. The active intervention will be composed of series of visits
      of patients attending the clinic every 2 months (or sooner, if needed) in which a specialized
      CF team member will follow on the progress of the patient in his field of expertise.
      Furthermore, frequent telephone calls for monitoring, educating and identifying barriers in
      adherence will be made by a designated team member such as the CF nurse or the CF clinical
      pharmacist.

      On identifying problems concerning medication adherence (such as: difficulties receiving
      medications from the sick fund, unwillingness to do inhaled medications because of allegedly
      side effects, difficulties in swallowing pills, etc.) solutions will be suggested by the CF
      team members and will be examined accordingly on the following visits.

      Adherence to specific chronic medications will be determined by a short self reported
      questionnaire, a structured interview with the clinical pharmacist and prescriptions refill
      history obtained from pharmacy records in every visit to the clinical pharmacist.

      Outcomes will be measured from patient's hospital records at baseline, 6 months and 12 months
      from the starting point. Measured clinical outcomes will be: PFTs, number of hospital
      admissions, number of exacerbations, number of IV courses, time between each exacerbation,
      inflammatory markers, BMI, HRQoL.
    

Intervention name(s): Frequent Scheduled CF clinic visits; frequent telephone calls to patients pre and post visits to the clinic
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mandatory scheduled visit at the CF clinic every 1-2 months or sooner, if needed, for an evaluation by a a specialized CF team member such as: a pulmonary physician, a gastroenterologist, a dietitian, a clinical pharmacist; Frequent telephone calls for monitoring, educating and identifying barriers in adherence will be made by a designated CF team member such as the CF nurse or the CF clinical pharmacist.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Medication Adherence; Multidisciplinary Team; Clinical Outcomes