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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 28, 2005
First Posted Date  ICMJE September 30, 2005
Results First Submitted Date  ICMJE May 18, 2009
Results First Posted Date  ICMJE July 7, 2010
Last Update Posted Date July 20, 2010
Study Start Date  ICMJE June 2004
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
SF-36 Physical Component [ Time Frame: 15 months ]
health related quality of life. Minimum: 0; Maximum 100.
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
Self-reported health status
Change History Complete list of historical versions of study NCT00229957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
  • Use of Hospital Services [ Time Frame: baseline, 15 months ]
    self report use of hospital service
  • Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs) [ Time Frame: baseline, 15 months ]
    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)
  • Functional Limitations [ Time Frame: baseline, 15 months ]
    Late Life Function and Disability Instrument: A measure of functional limitations and disability in older adults.
  • Falls and Injuries [ Time Frame: baseline, 15 months ]
    self-reported number of falls in last 6 months
  • HOME Falls and Accident Screening Tool (FAST) [ Time Frame: baseline, 15 months ]
    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.
  • Self-management and Self-efficacy [ Time Frame: baseline, 15 months ]
    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).
  • Physical Abilities (Strength, Balance) [ Time Frame: baseline, 15 months ]
    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).
  • Patient Satisfaction Questionnaire - 18 (Modified) [ Time Frame: 15 months ]
    Patient satisfaction with the care they received. (Score range 0-5)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
  • Use of Hospital Services
  • Independence in ADLs and IADLs
  • Functional Limitations
  • Community participation
  • Falls and Injuries
  • Home safety
  • Self-management and Self-efficacy
  • Physical Abilities (Strength, Balance)
  • Patient, physician, and nurse practitioner satisfaction
  • Costs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness
Official Title  ICMJE Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Disease
  • Hypertension
  • Back Pain
  • Obesity
  • Arthritis
Intervention  ICMJE
  • Behavioral: Occupational therapy
  • Behavioral: Physiotherapy
  • Behavioral: Self-management
Study Arms  ICMJE
  • Experimental: Intervention
    Intervention
    Interventions:
    • Behavioral: Occupational therapy
    • Behavioral: Physiotherapy
    • Behavioral: Self-management
  • No Intervention: Control
    Control group received usual care in primary care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2010)
303
Original Enrollment  ICMJE
 (submitted: September 28, 2005)
344
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 1 chronic condition
  • 3 visits to family physician in the past year

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 44 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00229957
Other Study ID Numbers  ICMJE 04-052
G03-02572
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE Ontario Ministry of Health and Long Term Care
Investigators  ICMJE
Principal Investigator: Lori Letts, PhD McMaster University
Principal Investigator: Julie Richardson, PhD McMaster University
PRS Account McMaster University
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP