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

• 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: Hamilton Health Sciences Corporation
• Collaborator: Ontario Ministry of Health and Long Term Care
• Information provided by: McMaster University

Tracking Information

• First Submitted Date: September 28, 2005
• First Posted Date: September 30, 2005
• Results First Submitted Date: May 18, 2009
• Results First Posted Date: July 7, 2010
• Last Update Posted Date: July 20, 2010
• Study Start Date: June 2004
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Chronic Disease
• Hypertension
• Back Pain
• Obesity
• Arthritis

Intervention

• Behavioral: Occupational therapy
• Behavioral: Physiotherapy
• Behavioral: Self-management

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 7, 2010): 303
• Original Enrollment (submitted: September 28, 2005): 344
• Actual Study Completion Date: October 2006
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• None

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 44 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00229957
• Other Study ID Numbers: 04-052; G03-02572
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Ontario Ministry of Health and Long Term Care

Investigators

• Principal Investigator: Lori Letts, PhD; McMaster University
• Principal Investigator: Julie Richardson, PhD; McMaster University

• PRS Account: McMaster University
• Verification Date: September 2009