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

NCT ID: NCT01025258

Last Updated: 2013-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-06-30

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Medication Adherence; Multidisciplinary Team; Clinical Outcomes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

frequent clinic visits

Group Type: ACTIVE_COMPARATOR

Frequent Scheduled CF clinic visits

Intervention Type: BEHAVIORAL

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 to patients pre and post visits to the clinic

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Ori Efrati

Head of Pediatric Pulmonary Dept

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ori Efrati, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Vardit M Kalamaro, BPharm, MSc

Role: STUDY_DIRECTOR

The Israeli Cystic Fibrosis Foundation

Ran Nissan, Pharm D Student

Role: STUDY_CHAIR

Hebrew University of Jerusalem

Locations

Pediatric pulmonary unit, The Edmod and Lili Safra children's Hospital, Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 11978927 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17990153 (View on PubMed)

Other Identifiers

SHEBA-09-7380-OE-CTIL

Identifier Type: -

Identifier Source: org_study_id