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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Ori Efrati, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01025258
First received: December 2, 2009
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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 Intervention
Cystic Fibrosis
Behavioral: Frequent Scheduled CF clinic visits
Behavioral: frequent telephone calls to patients pre and post visits to the clinic

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

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. [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether a collaborative intervention program of a multi-disciplinary team improves health related quality of life. [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • To inspect whether improved adherence to medications during intensive care for 1 year in CF will reduce cytokines and inflammatory markers [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   1 Year to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025258

Locations
Israel
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
  More Information

Publications:
Responsible Party: Prof. Ori Efrati, Head of Pediatric Pulmonary Dept, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01025258     History of Changes
Other Study ID Numbers: SHEBA-09-7380-OE-CTIL
Study First Received: December 2, 2009
Last Updated: September 2, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Cystic Fibrosis
Medication Adherence
Multidisciplinary Team
Clinical Outcomes

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014