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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00859638
Other study ID # 08-177
Secondary ID 2007-ORRAN-IIA-5
Status Completed
Phase N/A
First received March 10, 2009
Last updated June 17, 2010
Start date May 2008
Est. completion date April 2009

Study information

Verified date September 2009
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date April 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 44 Years and older
Eligibility Inclusion Criteria:

- 44 years and older

- 1 or more chronic conditions

- 3 visits to physician in the past year

- access or willingness to access email

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Behavioral:
Physiotherapy
group self-management classes
Occupational Therapy
group self-management classes
Capacity Building
workshops and case reviews with primary health care team members

Locations

Country Name City State
Canada McMaster Family Health Team (Stonechurch Family Health Centre and McMaster Family Practice) Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation Ontario Neurotrauma Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 4 months No
Secondary Self-rated Health 4 months No
Secondary Health Care Utilization 4 months No
Secondary Self-efficacy for Chronic Disease Scale 4 months No
Secondary Rapid Assessment of Physical Activity 4 months No
Secondary Grip Strength 4 months No
Secondary Two Minute Walk Test 4 months No
Secondary Patient Assessment of Chronic Illness Care 4 months No
Secondary Primary Care Resources and Supports 4 months No
Secondary Balance Screen 4 months No
Secondary Eight Foot Walk Test 4 months No
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