Improving Adherence and Clinical Outcome in Cystic Fibrosis (CF) Patients

Sponsor

Sheba Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01025258

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Behavioral: Frequent Scheduled CF clinic visits Behavioral: frequent telephone calls to patients pre and post visits to the clinic	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Improving Adherence and Clinical Outcomes of Cystic Fibrosis Patients Through a Collaborative Active Intervention Program of a Multidisciplinary Team

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: frequent clinic visits	Behavioral: Frequent Scheduled CF clinic visits 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 Behavioral: frequent telephone calls to patients pre and post visits to the clinic 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.

Arm

Intervention/Treatment

Active Comparator: frequent clinic visits

Behavioral: Frequent Scheduled CF clinic visits

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

Behavioral: frequent telephone calls to patients pre and post visits to the clinic

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.

Outcome Measures

Primary Outcome Measures

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. [6 months, 12 months]
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. [6 months, 12 months]

Secondary Outcome Measures

To determine whether a collaborative intervention program of a multi-disciplinary team improves health related quality of life. [6 months, 12 months]
To inspect whether improved adherence to medications during intensive care for 1 year in CF will reduce cytokines and inflammatory markers [6 months, 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with diagnosis of Cystic fibrosis at all ages.
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).
Patients willing to participate in a trial.
Presence of a parent/guardian capable of providing informed consent.
Patients attending CF clinic at least once every 12 months.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric pulmonary unit, The Edmod and Lili Safra children's Hospital, Sheba Medical Center	Ramat-Gan		Israel

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator: Ori Efrati, MD, Sheba Medical Center
Study Director: Vardit M Kalamaro, BPharm, MSc, The Israeli Cystic Fibrosis Foundation
Study Chair: Ran Nissan, Pharm D Student, Hebrew University of Jerusalem