NCT01025258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

December 2, 2009

Last Update Submit

September 2, 2013

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisMedication AdherenceMultidisciplinary TeamClinical Outcomes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

frequent clinic visits

ACTIVE COMPARATOR
Behavioral: Frequent Scheduled CF clinic visitsBehavioral: frequent telephone calls to patients pre and post visits to the clinic

Interventions

Frequent Scheduled CF clinic visitsBEHAVIORAL

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 clinic visits
frequent telephone calls to patients pre and post visits to the clinicBEHAVIORAL

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.

frequent clinic visits

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ramat Gan, Israel

Location

Related Publications (2)

  • 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.

    PMID: 11978927BACKGROUND

  • 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.

    PMID: 17990153BACKGROUND

MeSH Terms

Conditions

Cystic FibrosisMedication Adherence

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ori Efrati, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Vardit M Kalamaro, BPharm, MSc

    The Israeli Cystic Fibrosis Foundation

    STUDY DIRECTOR

  • Ran Nissan, Pharm D Student

    Hebrew University of Jerusalem

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Pulmonary Dept

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

IL(1)