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Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness

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ClinicalTrials.gov Identifier: NCT00229957
Recruitment Status : Completed
First Posted : September 30, 2005
Results First Posted : July 7, 2010
Last Update Posted : July 20, 2010
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by:
McMaster University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Disease
Hypertension
Back Pain
Obesity
Arthritis
Interventions Behavioral: Occupational therapy
Behavioral: Physiotherapy
Behavioral: Self-management
Enrollment 303
Recruitment Details All participants recruited from a family health practice.
Pre-assignment Details  
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme. Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
Period Title: Overall Study
Started 152 151
Completed 132 139
Not Completed 20 12
Arm/Group Title Intervention Group Control Group Total
Hide Arm/Group Description A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme. Usual care from the primary health care team which did not include physiotherapy or occupational therapy. Total of all reporting groups
Overall Number of Baseline Participants 152 151 303
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 151 participants 303 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
86
  56.6%
86
  57.0%
172
  56.8%
>=65 years
66
  43.4%
65
  43.0%
131
  43.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 151 participants 303 participants
Female
98
  64.5%
94
  62.3%
192
  63.4%
Male
54
  35.5%
57
  37.7%
111
  36.6%
1.Primary Outcome
Title SF-36 Physical Component
Hide Description health related quality of life. Minimum: 0; Maximum 100.
Time Frame 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
Overall Number of Participants Analyzed 132 139
Mean (Standard Deviation)
Unit of Measure: units on a scale
42.6  (11.8) 43.1  (11.9)
2.Secondary Outcome
Title Use of Hospital Services
Hide Description self report use of hospital service
Time Frame baseline, 15 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)
Hide Description 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)
Time Frame baseline, 15 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Functional Limitations
Hide Description Late Life Function and Disability Instrument: A measure of functional limitations and disability in older adults.
Time Frame baseline, 15 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Falls and Injuries
Hide Description self-reported number of falls in last 6 months
Time Frame baseline, 15 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title HOME Falls and Accident Screening Tool (FAST)
Hide Description 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.
Time Frame baseline, 15 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Self-management and Self-efficacy
Hide Description 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).
Time Frame baseline, 15 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Physical Abilities (Strength, Balance)
Hide Description 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).
Time Frame baseline, 15 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Patient Satisfaction Questionnaire - 18 (Modified)
Hide Description Patient satisfaction with the care they received. (Score range 0-5)
Time Frame 15 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme. Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
All-Cause Mortality
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/152 (0.00%)   0/151 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/152 (0.00%)   0/151 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Julie Richardson
Organization: McMaster University
Phone: 905-525-9140 ext 27811
EMail: jrichard@mcmaster.ca
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00229957     History of Changes
Other Study ID Numbers: 04-052
G03-02572
First Submitted: September 28, 2005
First Posted: September 30, 2005
Results First Submitted: May 18, 2009
Results First Posted: July 7, 2010
Last Update Posted: July 20, 2010