Chronic ConditionsNCT00859638
I Am Able: Population Based Rehabilitation in a Family Health Team
A study testing Physiotherapy, Occupational Therapy and Capacity Building in people with Chronic Conditions and Arthritis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
People who have long-term conditions such as heart disease, diabetes, arthritis etc. face challenges in staying active and able to participate in activities that are important to them. Read more about this study
- Who is it for?
- Ages 44 years and older
- Conditions the study is for
- Chronic Conditions, Arthritis, Diabetes
- What is being tested?
- Physiotherapy, Occupational Therapy and Capacity Building
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 44 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 44 years and older
- 1 or more chronic conditions
- 3 visits to physician in the past year
- access or willingness to access email
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster Family Health Team (Stonechurch Family Health Centre and McMaster Family Practice)
Hamilton, Ontario, L8W 3J6
About this study
People who have long-term conditions such as heart disease, diabetes, arthritis etc. face challenges in staying active and able to participate in activities that are important to them. There is some research that suggests that a care model that focuses on physical functioning and helping patients to manage their own conditions will assist them to stay active and healthy longer. In this project, the investigators are testing whether physiotherapy and occupational therapy offered to groups of patients and information about rehabilitation offered to other members of the health care team can help people with chronic conditions to maintain their physical abilities.
Read the detailed description
Participants older than 44, with at least one chronic disease, (n=60) will participate in a before-and-after study integrating a population based, rehabilitation-focused program targeting physical function into a Family Health Team. The program, delivered by a Physiotherapist and Occupational Therapist, will consist of comprehensive functional assessments and individualized self-management care plans; a rehabilitation based chronic disease self-management program; and on-line self-monitoring of physical function. Process and outcome measures will be administered at baseline and 4 months follow-up.
- Conditions
- Chronic Conditions, Arthritis, Diabetes, Hypertension, Chronic Pain
- Being tested
- Physiotherapy, Occupational Therapy, Capacity Building
- Medical subject headings
- Chronic Disease, Arthritis, Diabetes Mellitus, Hypertension, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyBehavioural
group self-management classes
Occupational TherapyBehavioural
group self-management classes
Capacity BuildingBehavioural
workshops and case reviews with primary health care team members
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building. Receives: Behavioral: Physiotherapy; Behavioral: Occupational Therapy; Behavioral: Capacity Building |
| Case matched controls | No intervention | Usual care in primary health care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Functioning Inventory (PFI)
The PFI is used to assess physical functioning in older adults. It contains 21 tasks from 4 subscales: activities of daily living, instrumental activities of daily living, mobility, moderate activities. A series of questions is used to determine whether the person experiences difficulty in completing a task, the level of difficulty they experience, and any changes to the method and/or frequency of task performance. The PFI is sensitive to steps in the natural history of functional decline that are often not assessed clinically. Range of scores: 0 (most difficulty); 100 (least difficulty).
Measured: 4 months
Secondary outcomes (10)
Self-rated Health
Measured: 4 months
Health Care Utilization
Measured: 4 months
Self-efficacy for Chronic Disease Scale
Measured: 4 months
Rapid Assessment of Physical Activity
Measured: 4 months
Grip Strength
Measured: 4 months
Two Minute Walk Test
Measured: 4 months
Patient Assessment of Chronic Illness Care
Measured: 4 months
Primary Care Resources and Supports
Measured: 4 months
Balance Screen
Measured: 4 months
Eight Foot Walk Test
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ConditionsStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Investigators
- Julie Richardson, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859638
- Sponsor's protocol ID
- 08-177
- Other IDs
- 2007-ORRAN-IIA-568
- Status last verified
- Sep 2009
- First submitted
- 10 Mar 2009
- Last updated
- 22 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Richardson J, Letts L, Chan D, Officer A, Wojkowski S, Oliver D, Moore A, McCarthy L, Price D, Kinzie S. Monitoring physical functioning as the sixth vital sign: evaluating patient and practice engagement in chronic illness care in a primary care setting--a quasi-experimental design. BMC Fam Pract. 2012 Apr 3;13:29. doi: 10.1186/1471-2296-13-29.
PubMed 22471378
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I Am Able: Population Based Rehabilitation in a Family Health Team
- ClinicalTrials.gov ID
- NCT00859638
- Acronym / sponsor ID
- 08-177
- Conditions
- Chronic Conditions, Arthritis, Diabetes, Hypertension, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Posted 17 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People who have long-term conditions such as heart disease, diabetes, arthritis etc. face challenges in staying active and able to participate in activities that are important to them. There is some research that suggests that a care model that focuses on physical functioning and helping patients to manage their own conditions will assist them to stay active and healthy longer. In this project, the investigators are testing whether physiotherapy and occupational therapy offered to groups of patients and information about rehabilitation offered to other members of the health care team can help people with chronic conditions to maintain their physical abilities.
Detailed description
Participants older than 44, with at least one chronic disease, (n=60) will participate in a before-and-after study integrating a population based, rehabilitation-focused program targeting physical function into a Family Health Team. The program, delivered by a Physiotherapist and Occupational Therapist, will consist of comprehensive functional assessments and individualized self-management care plans; a rehabilitation based chronic disease self-management program; and on-line self-monitoring of physical function. Process and outcome measures will be administered at baseline and 4 months follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Physiotherapy, Behavioral: Occupational Therapy, Behavioral: Capacity BuildingRehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building. |
| Case matched controls | No intervention | –Usual care in primary health care. |
Who may qualify
- Ages
- 44 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 44 years and older
- 1 or more chronic conditions
- 3 visits to physician in the past year
- access or willingness to access email
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Physiotherapygroup self-management classes | Behavioural | Intervention Group |
| Occupational Therapygroup self-management classes | Behavioural | Intervention Group |
| Capacity Buildingworkshops and case reviews with primary health care team members | Behavioural | Intervention Group |
Primary outcome
Physical Functioning Inventory (PFI)
Time frame: 4 months
The PFI is used to assess physical functioning in older adults. It contains 21 tasks from 4 subscales: activities of daily living, instrumental activities of daily living, mobility, moderate activities. A series of questions is used to determine whether the person experiences difficulty in completing a task, the level of difficulty they experience, and any changes to the method and/or frequency of task performance. The PFI is sensitive to steps in the natural history of functional decline that are often not assessed clinically. Range of scores: 0 (most difficulty); 100 (least difficulty).
10 secondary outcomes
Self-rated Health
Time frame: 4 months
Health Care Utilization
Time frame: 4 months
Self-efficacy for Chronic Disease Scale
Time frame: 4 months
Rapid Assessment of Physical Activity
Time frame: 4 months
Grip Strength
Time frame: 4 months
Two Minute Walk Test
Time frame: 4 months
Patient Assessment of Chronic Illness Care
Time frame: 4 months
Primary Care Resources and Supports
Time frame: 4 months
Balance Screen
Time frame: 4 months
Eight Foot Walk Test
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22471378Richardson J, Letts L, Chan D, Officer A, Wojkowski S, Oliver D, Moore A, McCarthy L, Price D, Kinzie S. Monitoring physical functioning as the sixth vital sign: evaluating patient and practice engagement in chronic illness care in a primary care setting--a quasi-experimental design. BMC Fam Pract. 2012 Apr 3;13:29. doi: 10.1186/1471-2296-13-29.
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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.
Julie Richardson, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy, Occupational Therapy and Capacity Building in people with Chronic Conditions and Arthritis, run by Hamilton Health Sciences Corporation 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 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 22 Jun 2010. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Functioning Inventory (PFI) (time frame: 4 months). 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 NCT00859638, 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 22 Jun 2010; AzTrials last refreshed its copy on 8 Nov 2026.