Cystic FibrosisNCT01025258
Improving Adherence and Clinical Outcome in Cystic Fibrosis (CF) Patients
A study testing Frequent Scheduled CF clinic visits and frequent telephone calls to patients pre and post visits to the clinic in people with Cystic Fibrosis, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Frequent Scheduled CF clinic visits and frequent telephone calls to patients pre and post visits to the clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Absence of a parent/guardian or unwillingness to provide permission.
- Potential participant declines to provide assent.
- Transplant patients.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric pulmonary unit, The Edmod and Lili Safra children's Hospital, Sheba Medical Center
Ramat Gan
About this study
Official title: Improving Adherence and Clinical Outcomes of Cystic Fibrosis Patients Through a Collaborative Active Intervention Program of a Multidisciplinary Team
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.
Read the 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
- Being tested
- Frequent Scheduled CF clinic visits, frequent telephone calls to patients pre and post visits to the clinic
- Keywords
- Cystic Fibrosis, Medication Adherence, Multidisciplinary Team, Clinical Outcomes
- Medical subject headings
- Cystic Fibrosis, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequent Scheduled CF clinic visitsBehavioural
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 clinicBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| frequent clinic visits | Active comparator | Not described Receives: Behavioral: Frequent Scheduled CF clinic visits; Behavioral: frequent telephone calls to patients pre and post visits to the clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Ori Efrati, Sheba Medical Center
- Investigators
- Ori Efrati, MD, Principal investigator, Sheba Medical CenterVardit M Kalamaro, BPharm, MSc, Study director, The Israeli Cystic Fibrosis FoundationRan Nissan, Pharm D Student, Study chair, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025258
- Sponsor's protocol ID
- SHEBA-09-7380-OE-CTIL
- Status last verified
- Sep 2013
- First submitted
- 2 Dec 2009
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11978927Hofer 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.
PubMed 17990153
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence and Clinical Outcomes of Cystic Fibrosis Patients Through a Collaborative Active Intervention Program of a Multidisciplinary Team
- ClinicalTrials.gov ID
- NCT01025258
- Acronym / sponsor ID
- SHEBA-09-7380-OE-CTIL
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Medication Adherence, Multidisciplinary Team, Clinical Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| frequent clinic visits | Active comparator | Behavioral: Frequent Scheduled CF clinic visits, Behavioral: frequent telephone calls to patients pre and post visits to the clinic |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Absence of a parent/guardian or unwillingness to provide permission.
- Potential participant declines to provide assent.
- Transplant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequent Scheduled CF clinic visitsMandatory 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 | Behavioural | frequent clinic visits |
| frequent telephone calls to patients pre and post visits to the clinicFrequent 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. | Behavioural | frequent clinic visits |
Primary outcome
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
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
2 secondary outcomes
To determine whether a collaborative intervention program of a multi-disciplinary team improves health related quality of life.
Time frame: 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
Time frame: 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Background: PubMed 11978927Kettler 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.
- Background: PubMed 17990153Hofer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ori Efrati, MD principal investigator
Sheba Medical Center
Vardit M Kalamaro, BPharm, MSc study director
The Israeli Cystic Fibrosis Foundation
Ran Nissan, Pharm D Student study chair
Hebrew University of Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequent Scheduled CF clinic visits and frequent telephone calls to patients pre and post visits to the clinic in people with Cystic Fibrosis, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01025258, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.