Chronic IllnessPhase 1NCT00153829
Chronic Illness Care Management (CICM) Study In Primary Care
A Phase 1 study testing Multifaceted outreach facilitation for chronic illness care in people with Chronic Illness and Quality of Life, run by C. T. Lamont Primary Care Research Centre at 1 site in Canada.
Trial summary
The purpose of the study is to determine whether the quality of life of patients with multiple chronic conditions cared for by primary care physicians will improve due to the introduction of a chronic illness management intervention. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Illness, Quality of Life
- What is being tested?
- Multifaceted outreach facilitation for chronic illness care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2004to Feb 2006
- Phase
- Phase 1
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient should suffer from any two or more chronic illnesses
- Patient should have been seen in the GP's office at least six to seven times in the previous year
- Patient should be 50 years of age or older
Who cannot join
- Suffering from dementia or a major psychiatric condition, being terminally ill, not being competent to give informed consent for participating in the study, or the doctors considers that the patient will not benefit from the intervention.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Ottawa, Institute of Population Health
Ottawa, Ontario, K1N 6N5
About this study
The purpose of the study is to determine whether the quality of life of patients with multiple chronic conditions cared for by primary care physicians will improve due to the introduction of a chronic illness management intervention.
Read the detailed description
There is international recognition for the need of introducing improvement in chronic illness care. However, primary care physicians face a host of challenges for providing the best possible care to their patients. One of these problems is the lack of proper administrative systems. There is evidence indicating that tailored out reach facilitation is an effective means to improve practice performance. Traditionally, the approach to care for chronically ill patients revolved mostly around the treatment of a specific chronic condition in an ad hoc basis. It is more common in family medicine for the patient to have several chronic conditions. There is also evidence showing that better health outcomes are obtained when the patients' life circumstances, desires and expectations are taken into consideration. Various models of chronic illness care have emerged that are patient center while attempting to be comprehensive. Our approach, following the Australian model, seeks to introduce systems/administrative innovations at the practice level, intended also to increase the involvement of patients with multiple chronic conditions on its own care, throw tailored out reach facilitation and care planning tools for physicians, in order to improve chronic illness management in primary care settings.
- Conditions
- Chronic Illness, Quality of Life
- Being tested
- Multifaceted outreach facilitation for chronic illness care
- Keywords
- Chronic Disease, Quality of Life
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted outreach facilitation for chronic illness careBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between intervention and control groups of the average of the total SF-36 Health Survey physical and mental scores
Secondary outcomes (1)
Difference between intervention and control groups of the average of the 'Healthy Days' Health Related Quality of Life-4 (HRQOL-4) scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- C. T. Lamont Primary Care Research Centre
- Sponsor type
- University, hospital or other
- Investigators
- William Hogg, MD, CCFP, Principal investigator, University of OttawaJacques Lemelin, MD, CCFP, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153829
- Sponsor's protocol ID
- T-0528-029-22-CICM
- Status last verified
- Feb 2015
- First submitted
- 8 Sep 2005
- Last updated
- 23 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Illness Care Management (CICM) Study In Primary Care
- ClinicalTrials.gov ID
- NCT00153829
- Acronym / sponsor ID
- T-0528-029-22-CICM
- Conditions
- Chronic Illness, Quality of Life
- Keywords
- Chronic Disease, Quality of Life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- C. T. Lamont Primary Care Research CentreUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Feb 2006
- First posted
- 12 Sep 2005 (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 the study is to determine whether the quality of life of patients with multiple chronic conditions cared for by primary care physicians will improve due to the introduction of a chronic illness management intervention.
Detailed description
There is international recognition for the need of introducing improvement in chronic illness care. However, primary care physicians face a host of challenges for providing the best possible care to their patients. One of these problems is the lack of proper administrative systems. There is evidence indicating that tailored out reach facilitation is an effective means to improve practice performance. Traditionally, the approach to care for chronically ill patients revolved mostly around the treatment of a specific chronic condition in an ad hoc basis. It is more common in family medicine for the patient to have several chronic conditions. There is also evidence showing that better health outcomes are obtained when the patients' life circumstances, desires and expectations are taken into consideration. Various models of chronic illness care have emerged that are patient center while attempting to be comprehensive. Our approach, following the Australian model, seeks to introduce systems/administrative innovations at the practice level, intended also to increase the involvement of patients with multiple chronic conditions on its own care, throw tailored out reach facilitation and care planning tools for physicians, in order to improve chronic illness management in primary care settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient should suffer from any two or more chronic illnesses
- Patient should have been seen in the GP's office at least six to seven times in the previous year
- Patient should be 50 years of age or older
Key exclusion criteria (1 listed)
- Suffering from dementia or a major psychiatric condition, being terminally ill, not being competent to give informed consent for participating in the study, or the doctors considers that the patient will not benefit from the intervention.
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 |
|---|---|---|
| Multifaceted outreach facilitation for chronic illness care | Behavioural | – |
Primary outcome
Difference between intervention and control groups of the average of the total SF-36 Health Survey physical and mental scores
1 secondary outcome
Difference between intervention and control groups of the average of the 'Healthy Days' Health Related Quality of Life-4 (HRQOL-4) scores
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 23 Feb 2015.
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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.
William Hogg, MD, CCFP principal investigator
University of Ottawa
Jacques Lemelin, MD, CCFP principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multifaceted outreach facilitation for chronic illness care in people with Chronic Illness and Quality of Life, run by C. T. Lamont Primary Care Research Centre 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 3 inclusion and 1 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 23 Feb 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference between intervention and control groups of the average of the total SF-36 Health Survey physical and mental scores. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2015.