DiabetesPhase 2/3NCT00238836
Anticipatory & Preventive Team Care (APTCare): At Risk Patients of Family Health Networks
A Phase 2/3 study testing Self-management of chronic illness in people with Diabetes and Chronic Obstructive Pulmonary Disease, run by C. T. Lamont Primary Care Research Centre at 1 site in Canada.
Trial summary
The University of Ottawa and Élisabeth Bruyère Research Institute are conducting a study of preventive care for frail patients at risk of functional decline. At risk patients are assigned by chance to continue receiving their standard care from their family physician or receive additional care from a nurse… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
- What is being tested?
- Self-management of chronic illness
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento Mar 2006
- Phase
- Phase 2/3
- 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
- 50 years and over
- 'At Risk' by having one or more of the following: a. Visits to emergency dept within the past 6 months; b. Admission to hospital for a medical problem in past 6 months; c. High service use profiles; d. Polypharmacy; e. Other high risk factors
- Capable of giving informed consent
- Able to use the Care Companion technology
Who cannot join
- Cognitive impairment such that they cannot give informed consent
- Unable or unwilling to use the telehomecare equipment
- Unlikely to tolerate the intensive intervention
- Language or cultural barriers
- Being acutely ill or having an unstable condition on entry to the study
Trial locations and contacts
1 site in 1 country.
About this study
The University of Ottawa and Élisabeth Bruyère Research Institute are conducting a study of preventive care for frail patients at risk of functional decline. At risk patients are assigned by chance to continue receiving their standard care from their family physician or receive additional care from a nurse practitioners and a pharmacist. In collaboration with the family physician, they develop an individualized care plan, a treatment and management road plan, for each patient, which they implement over the study period of one approximately year. The objective of the study is to compare the effectiveness of the model of care that includes the nurse practitioners and pharmacist against standard care in preventing functional decline, to determine the acceptability of this model of care to patients, their caregivers and the medical team, and to evaluate the cost implication of the program.
- Being tested
- Self-management of chronic illness
- Medical subject headings
- Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive, Heart Failure, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management of chronic illnessBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- C. T. Lamont Primary Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, University of Ottawa
- Investigators
- William Hogg, MD, Principal investigator, C. T. Lamont Primary Care Research CentreJacques Lemelin, MD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238836
- Sponsor's protocol ID
- APTCare
- Status last verified
- Jun 2005
- First submitted
- 12 Oct 2005
- Last updated
- 13 Oct 2006
- Results posted
- No
Publications
Fletcher J, Hogg W, Farrell B, Woodend K, Dahrouge S, Lemelin J, Dalziel W. Effect of nurse practitioner and pharmacist counseling on inappropriate medication use in family practice. Can Fam Physician. 2012 Aug;58(8):862-8.
PubMed 22893340Dahrouge S, Hogg W, Lemelin J, Liddy C, Legault F. Methods for a study of Anticipatory and Preventive multidisciplinary Team Care in a family practice. Can Fam Physician. 2010 Feb;56(2):e73-83.
PubMed 20154234Gray D, Armstrong CD, Dahrouge S, Hogg W, Zhang W. Cost-effectiveness of Anticipatory and Preventive multidisciplinary Team Care for complex patients: evidence from a randomized controlled trial. Can Fam Physician. 2010 Jan;56(1):e20-9.
PubMed 20090057Hogg W, Lemelin J, Dahrouge S, Liddy C, Armstrong CD, Legault F, Dalziel B, Zhang W. Randomized controlled trial of anticipatory and preventive multidisciplinary team care: for complex patients in a community-based primary care setting. Can Fam Physician. 2009 Dec;55(12):e76-85.
PubMed 20008582
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipatory & Preventive Team Care (APTCare): At Risk Patients of Family Health Networks
- ClinicalTrials.gov ID
- NCT00238836
- Acronym / sponsor ID
- APTCare
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants
- Lead sponsor
- C. T. Lamont Primary Care Research CentreUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, University of Ottawa
- Study completion
- Mar 2006
- First posted
- 14 Oct 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 University of Ottawa and Élisabeth Bruyère Research Institute are conducting a study of preventive care for frail patients at risk of functional decline. At risk patients are assigned by chance to continue receiving their standard care from their family physician or receive additional care from a nurse practitioners and a pharmacist. In collaboration with the family physician, they develop an individualized care plan, a treatment and management road plan, for each patient, which they implement over the study period of one approximately year. The objective of the study is to compare the effectiveness of the model of care that includes the nurse practitioners and pharmacist against standard care in preventing functional decline, to determine the acceptability of this model of care to patients, their caregivers and the medical team, and to evaluate the cost implication of the program.
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 (4 listed)
- 50 years and over
- 'At Risk' by having one or more of the following: a. Visits to emergency dept within the past 6 months; b. Admission to hospital for a medical problem in past 6 months; c. High service use profiles; d. Polypharmacy; e. Other high risk factors
- Capable of giving informed consent
- Able to use the Care Companion technology
Key exclusion criteria (5 listed)
- Cognitive impairment such that they cannot give informed consent
- Unable or unwilling to use the telehomecare equipment
- Unlikely to tolerate the intensive intervention
- Language or cultural barriers
- Being acutely ill or having an unstable condition on entry to the study
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 |
|---|---|---|
| Self-management of chronic illness | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2006.
- Derived from this study: PubMed 22893340Fletcher J, Hogg W, Farrell B, Woodend K, Dahrouge S, Lemelin J, Dalziel W. Effect of nurse practitioner and pharmacist counseling on inappropriate medication use in family practice. Can Fam Physician. 2012 Aug;58(8):862-8.
- Derived from this study: PubMed 20154234Dahrouge S, Hogg W, Lemelin J, Liddy C, Legault F. Methods for a study of Anticipatory and Preventive multidisciplinary Team Care in a family practice. Can Fam Physician. 2010 Feb;56(2):e73-83.
- Derived from this study: PubMed 20090057Gray D, Armstrong CD, Dahrouge S, Hogg W, Zhang W. Cost-effectiveness of Anticipatory and Preventive multidisciplinary Team Care for complex patients: evidence from a randomized controlled trial. Can Fam Physician. 2010 Jan;56(1):e20-9.
- Derived from this study: PubMed 20008582Hogg W, Lemelin J, Dahrouge S, Liddy C, Armstrong CD, Legault F, Dalziel B, Zhang W. Randomized controlled trial of anticipatory and preventive multidisciplinary team care: for complex patients in a community-based primary care setting. Can Fam Physician. 2009 Dec;55(12):e76-85.
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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 principal investigator
C. T. Lamont Primary Care Research Centre
Jacques Lemelin, MD 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 2/3 study testing Self-management of chronic illness in people with Diabetes and Chronic Obstructive Pulmonary Disease, 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 4 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: status not confirmed, as of the sponsor's last update on 13 Oct 2006. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00238836, which also lists 4 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 13 Oct 2006.