Cystic FibrosisNCT00345449
Evaluation of a Decision Aid for Adult Cystic Fibrosis Patients Considering Bilateral Lung Transplantation
A study testing Decision Aid in people with Cystic Fibrosis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
In 2006, the International Patient Decision Aids Collaboration (IPDAS) reached agreement on criteria for evaluation. Accordingly, the primary outcome is 'decision quality' 3 weeks after using the decision aid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Sep 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FEV less than or equal to 40% predicted
Who cannot join
- Patients unable to provide informed consent
- Patients on a lung transplant waiting list
- Patients who are lung transplant recipients
- Patients deemed too sick for transplant
- Only one sibling per family to minimize contamination
Trial locations and contacts
1 site in 1 country.
About this study
In 2006, the International Patient Decision Aids Collaboration (IPDAS) reached agreement on criteria for evaluation. Accordingly, the primary outcome is 'decision quality' 3 weeks after using the decision aid. Decision quality is defined as the extent to which a patient decision aid improves the match between the chosen option and the features that matter most to the informed patient. Measures include: a) patients' knowledge of essential facts [options, benefits, harms, and outcome probabilities]; and b. the congruence between the option chosen and patients' informed values regarding benefits and risks.
In the past twenty years lung transplantation has become the most widely accepted option of treating cystic fibrosis patients with severe lung disease. Lung transplantation can be a good experience for many patients, improving their quality of life and their survival. However there are potential risks of lung transplantation including infection, organ rejection and early death. Cystic fibrosis patients are often faced with making a choice of whether to be referred for lung transplantation when they are very sick and there is the immediate need to survive. Our group has developed a tool called a decision aid which we hope will assist the patient and family in making this choice. The decision aid guides the patient through a series of steps where they weigh the benefits and risks of being referred for lung transplantation and the benefits and risks of receiving 'usual care' without the option of referral.
Read the detailed description
Patients randomized to either arm of the study will be required to undergo a lung transplantation education and counselling session with their CF physician prior to randomization. Subsequent to this session patients will be randomly allocated to receive: 1) usual care plus the patient decision aid or 2) usual care. For purposes of this study, usual care will include a booklet entitled, "Cystic fibrosis and lung transplantation" written by the Canadian Cystic Fibrosis Foundation plus any other written or educational material that the local CF centre normally provides.
- Conditions
- Cystic Fibrosis
- Being tested
- Decision Aid
- Keywords
- cystic fibrosis,, lung disease,, lung transplantation,, decision aid
- Medical subject headings
- Cystic Fibrosis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, realistic expectations and decisional conflict 3 weeks after using the decision aid.
Secondary outcomes (1)
Durability of the decision one year after the patient decision aid.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startSep 2006
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Ottawa Hospital Research InstituteThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Shawn Aaron, MD FRCPC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345449
- Sponsor's protocol ID
- 2004776-01
- Status last verified
- Jul 2009
- First submitted
- 27 Jun 2006
- Last updated
- 9 Jul 2009
- Results posted
- No
Publications
Vandemheen KL, O'Connor A, Bell SC, Freitag A, Bye P, Jeanneret A, Berthiaume Y, Brown N, Wilcox P, Ryan G, Brager N, Rabin H, Morrison N, Gibson P, Jackson M, Paterson N, Middleton P, Aaron SD. Randomized trial of a decision aid for patients with cystic fibrosis considering lung transplantation. Am J Respir Crit Care Med. 2009 Oct 15;180(8):761-8. doi: 10.1164/rccm.200903-0421OC. Epub 2009 Jul 9.
PubMed 19590021
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Decision Aid for Adult Cystic Fibrosis Patients Considering Bilateral Lung Transplantation
- ClinicalTrials.gov ID
- NCT00345449
- Acronym / sponsor ID
- 2004776-01
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis,, lung disease,, lung transplantation,, decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Sep 2008 (actual)
- First posted
- 28 Jun 2006 (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.
In 2006, the International Patient Decision Aids Collaboration (IPDAS) reached agreement on criteria for evaluation. Accordingly, the primary outcome is 'decision quality' 3 weeks after using the decision aid. Decision quality is defined as the extent to which a patient decision aid improves the match between the chosen option and the features that matter most to the informed patient. Measures include: a) patients' knowledge of essential facts [options, benefits, harms, and outcome probabilities]; and b. the congruence between the option chosen and patients' informed values regarding benefits and risks.
In the past twenty years lung transplantation has become the most widely accepted option of treating cystic fibrosis patients with severe lung disease. Lung transplantation can be a good experience for many patients, improving their quality of life and their survival. However there are potential risks of lung transplantation including infection, organ rejection and early death. Cystic fibrosis patients are often faced with making a choice of whether to be referred for lung transplantation when they are very sick and there is the immediate need to survive. Our group has developed a tool called a decision aid which we hope will assist the patient and family in making this choice. The decision aid guides the patient through a series of steps where they weigh the benefits and risks of being referred for lung transplantation and the benefits and risks of receiving 'usual care' without the option of referral.
Detailed description
Patients randomized to either arm of the study will be required to undergo a lung transplantation education and counselling session with their CF physician prior to randomization. Subsequent to this session patients will be randomly allocated to receive: 1) usual care plus the patient decision aid or 2) usual care. For purposes of this study, usual care will include a booklet entitled, "Cystic fibrosis and lung transplantation" written by the Canadian Cystic Fibrosis Foundation plus any other written or educational material that the local CF centre normally provides.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- FEV less than or equal to 40% predicted
Key exclusion criteria (5 listed)
- Patients unable to provide informed consent
- Patients on a lung transplant waiting list
- Patients who are lung transplant recipients
- Patients deemed too sick for transplant
- Only one sibling per family to minimize contamination
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 |
|---|---|---|
| Decision Aid | Behavioural | – |
Primary outcome
Knowledge, realistic expectations and decisional conflict 3 weeks after using the decision aid.
1 secondary outcome
Durability of the decision one year after the patient decision aid.
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 9 Jul 2009.
- Derived from this study: PubMed 19590021Vandemheen KL, O'Connor A, Bell SC, Freitag A, Bye P, Jeanneret A, Berthiaume Y, Brown N, Wilcox P, Ryan G, Brager N, Rabin H, Morrison N, Gibson P, Jackson M, Paterson N, Middleton P, Aaron SD. Randomized trial of a decision aid for patients with cystic fibrosis considering lung transplantation. Am J Respir Crit Care Med. 2009 Oct 15;180(8):761-8. doi: 10.1164/rccm.200903-0421OC. Epub 2009 Jul 9.
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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.
Shawn Aaron, MD FRCPC principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Cystic Fibrosis, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 1 inclusion and 5 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 9 Jul 2009. 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 Canada. 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?
Knowledge, realistic expectations and decisional conflict 3 weeks after using the decision aid.. 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 NCT00345449, which also lists 1 linked publication.
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 9 Jul 2009.