Chronic DiseaseNCT00229957
Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness
A study testing Occupational therapy, Physiotherapy and Self-management in people with Chronic Disease and Hypertension, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The purpose of the study is to determine whether occupational therapy and physiotherapy delivered in a primary care setting to adults with chronic illness is effective in improving health. Read more about this study
- Who is it for?
- Ages 44 years and older
- Conditions the study is for
- Chronic Disease, Hypertension, Back Pain
- What is being tested?
- Occupational therapy, Physiotherapy and Self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2004to Oct 2006
- 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
- At least 1 chronic condition
- 3 visits to family physician in the past year
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site
Stonechurch Family Health Centre, 549 Stonechurch Rd. E.
Hamilton, Ontario, L8W 3L2
About this study
The purpose of the study is to determine whether occupational therapy and physiotherapy delivered in a primary care setting to adults with chronic illness is effective in improving health.
Read the detailed description
Primary health care is changing so that people receive the care that they need at the front line. Rehabilitation has been identified as one service that should be offered in primary care, to address the needs of adults who have or are at risk of poor health from chronic conditions such as arthritis, heart disease and depression.
Two full time therapists (one physiotherapist and one occupational therapist) will offer rehabilitation to a sample of 170 adults with chronic illness over an 18 month period (170 people will also be enrolled in a control group) at the Stonechurch Family Health Centre. Key outcomes include health, hospital admissions and emergency room visits.
- Conditions
- Chronic Disease, Hypertension, Back Pain, Obesity, Arthritis
- Being tested
- Occupational therapy, Physiotherapy, Self-management
- Keywords
- Occupational therapy, Physical therapy techniques, Primary health care, Chronic disease, Rehabilitation, Disease management, Self care
- Medical subject headings
- Chronic Disease, Hypertension, Back Pain, Obesity, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational therapyBehavioural
PhysiotherapyBehavioural
Self-managementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention Receives: Behavioral: Occupational therapy; Behavioral: Physiotherapy; Behavioral: Self-management |
| Control | No intervention | Control group received usual care in primary care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 Physical Component
health related quality of life. Minimum: 0; Maximum 100.
Measured: 15 months
Secondary outcomes (8)
Use of Hospital Services
self report use of hospital service
Measured: baseline, 15 months
Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)
Late Life Function and Disability Instrument: A measure of disability and functional limitations in older adults. (Score range 0-100 with 100 representing better ability and less disability/functional limitation)
Measured: baseline, 15 months
Functional Limitations
Late Life Function and Disability Instrument: A measure of functional limitations and disability in older adults.
Measured: baseline, 15 months
Falls and Injuries
self-reported number of falls in last 6 months
Measured: baseline, 15 months
HOME Falls and Accident Screening Tool (FAST)
This is a home assessment of safety hazards for falls present in the individual's home. This tool helps to identify seniors at risk of falls. Score 0-25.
Measured: baseline, 15 months
Self-management and Self-efficacy
Individual's self-reported ability to carry out behaviours to self-manage their health condition, and their confidence level in being able to carry out these behaviours. (Score range 0= not confident at all, 10= totally confident).
Measured: baseline, 15 months
Physical Abilities (Strength, Balance)
Grip strength was measured using a JAMAR hand grip dynamometer (in kilograms). The Lower Extremity Function test is a battery of three tests used to measure lower extremity function and balance: a balance test, 8 foot walk test, and repetitive standing from a chair. A performance summary score is created by adding the number of seconds achieved on the balance test, the number of seconds to walk 8 feet and the number of seconds it takes the person to stand up from a chair five times consecutively (no maximum score exists on this measure).
Measured: baseline, 15 months
Patient Satisfaction Questionnaire - 18 (Modified)
Patient satisfaction with the care they received. (Score range 0-5)
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionAug 2006
- Study completionOct 2006
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.
- Other trials for Chronic DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Investigators
- Lori Letts, PhD, Principal investigator, McMaster UniversityJulie Richardson, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229957
- Sponsor's protocol ID
- 04-052
- Other IDs
- G03-02572
- Status last verified
- Sep 2009
- First submitted
- 28 Sep 2005
- Last updated
- 20 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness
- ClinicalTrials.gov ID
- NCT00229957
- Acronym / sponsor ID
- 04-052
- Conditions
- Chronic Disease, Hypertension, Back Pain, Obesity, Arthritis
- Keywords
- Occupational therapy, Physical therapy techniques, Primary health care, Chronic disease, Rehabilitation, Disease management, Self care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Jun 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 30 Sep 2005 (estimated)
- Results
- Posted 7 Jul 2010
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 occupational therapy and physiotherapy delivered in a primary care setting to adults with chronic illness is effective in improving health.
Detailed description
Primary health care is changing so that people receive the care that they need at the front line. Rehabilitation has been identified as one service that should be offered in primary care, to address the needs of adults who have or are at risk of poor health from chronic conditions such as arthritis, heart disease and depression.
Two full time therapists (one physiotherapist and one occupational therapist) will offer rehabilitation to a sample of 170 adults with chronic illness over an 18 month period (170 people will also be enrolled in a control group) at the Stonechurch Family Health Centre. Key outcomes include health, hospital admissions and emergency room visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Occupational therapy, Behavioral: Physiotherapy, Behavioral: Self-managementIntervention |
| Control | No intervention | –Control group received usual care in primary care. |
Who may qualify
- Ages
- 44 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 1 chronic condition
- 3 visits to family physician in the past year
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 |
|---|---|---|
| Occupational therapy | Behavioural | Intervention |
| Physiotherapy | Behavioural | Intervention |
| Self-management | Behavioural | Intervention |
Primary outcome
SF-36 Physical Component
Time frame: 15 months
health related quality of life. Minimum: 0; Maximum 100.
8 secondary outcomes
Use of Hospital Services
Time frame: baseline, 15 months
Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)
Time frame: baseline, 15 months
Functional Limitations
Time frame: baseline, 15 months
Falls and Injuries
Time frame: baseline, 15 months
HOME Falls and Accident Screening Tool (FAST)
Time frame: baseline, 15 months
Self-management and Self-efficacy
Time frame: baseline, 15 months
Physical Abilities (Strength, Balance)
Time frame: baseline, 15 months
Patient Satisfaction Questionnaire - 18 (Modified)
Time frame: 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lori Letts, PhD principal investigator
McMaster University
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 Occupational therapy, Physiotherapy and Self-management in people with Chronic Disease and Hypertension, 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 2 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 20 Jul 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 7 Jul 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?
SF-36 Physical Component (time frame: 15 months). 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 20 Jul 2010.