Clinical trial NCT01025258: Improving Adherence and Clinical Outcome in Cystic Fibrosis (CF) Patients
Official title: Improving Adherence and Clinical Outcomes of Cystic Fibrosis Patients Through a Collaborative Active Intervention Program of a Multidisciplinary Team
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Medication Adherence
Multidisciplinary Team
Clinical Outcomes
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-12-03
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with diagnosis of Cystic fibrosis at all ages.
2. CF patients that should be treated with one or more of these chronic medications: Tobi (Tobramycin), Coliracin (Colistin), Pulmozyme (Dornase Alpha), Hypertonic Saline (HS), Creon (pancreatic enzymes), AquaADEKs (Multivitamin).
3. Patients willing to participate in a trial.
4. Presence of a parent/guardian capable of providing informed consent.
5. Patients attending CF clinic at least once every 12 months.

Exclusion Criteria:

1. Absence of a parent/guardian or unwillingness to provide permission.
2. Potential participant declines to provide assent.
3. Transplant patients.

Primary outcomes:
measure: To determine whether a collaborative intervention program of a multi disciplinary team improves clinical outcomes such as: number of hospital admissions, number of IV ABx courses, and change in %FEV1, BMI.
timeFrame: 6 months, 12 months
measure: To determine whether a collaborative intervention program of a multi disciplinary team improves adherence to routinely prescribed CF medications: Tobi, Pulmozyme, Colistine , HS, Creon and AquADEKs multivitamins.
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: To determine whether a collaborative intervention program of a multi-disciplinary team improves health related quality of life.
timeFrame: 6 months, 12 months
measure: To inspect whether improved adherence to medications during intensive care for 1 year in CF will reduce cytokines and inflammatory markers
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Pediatric pulmonary unit, The Edmod and Lili Safra children's Hospital, Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Ori Efrati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Israeli Cystic Fibrosis Foundation
name: Vardit M Kalamaro, BPharm, MSc
role: STUDY_DIRECTOR
affiliation: Hebrew University of Jerusalem
name: Ran Nissan, Pharm D Student
role: STUDY_CHAIR
References:
citation: Kettler LJ, Sawyer SM, Winefield HR, Greville HW. Determinants of adherence in adults with cystic fibrosis. Thorax. 2002 May;57(5):459-64. doi: 10.1136/thorax.57.5.459.
citation: Hofer M. Advanced chronic lung disease: need for an active interdisciplinary approach. Swiss Med Wkly. 2007 Nov 3;137(43-44):593-601. doi: 10.4414/smw.2007.11680.