NCT00859638

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 17, 2010

Completed
Last Updated

June 22, 2010

Status Verified

September 1, 2009

Enrollment Period

10 months

First QC Date

March 10, 2009

Results QC Date

September 29, 2009

Last Update Submit

June 17, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • Self-rated Health

    4 months

  • Health Care Utilization

    4 months

  • Self-efficacy for Chronic Disease Scale

    4 months

  • Rapid Assessment of Physical Activity

    4 months

  • Grip Strength

    4 months

  • +5 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.

Behavioral: PhysiotherapyBehavioral: Occupational TherapyBehavioral: Capacity Building

Case matched controls

NO INTERVENTION

Usual care in primary health care.

Interventions

PhysiotherapyBEHAVIORAL

group self-management classes

Intervention Group

group self-management classes

Intervention Group

workshops and case reviews with primary health care team members

Intervention Group

Eligibility Criteria

Age44 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • or more chronic conditions
  • visits to physician in the past year
  • access or willingness to access email

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster Family Health Team (Stonechurch Family Health Centre and McMaster Family Practice)

Hamilton, Ontario, L8W 3J6, Canada

Location

Related Publications (1)

  • Richardson J, Letts L, Chan D, Officer A, Wojkowski S, Oliver D, Moore A, McCarthy L, Price D, Kinzie S. Monitoring physical functioning as the sixth vital sign: evaluating patient and practice engagement in chronic illness care in a primary care setting--a quasi-experimental design. BMC Fam Pract. 2012 Apr 3;13:29. doi: 10.1186/1471-2296-13-29.

MeSH Terms

Conditions

Chronic DiseaseArthritisDiabetes MellitusHypertensionChronic Pain

Interventions

Physical Therapy ModalitiesOccupational TherapyCapacity Building

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CareHealth Care Facilities Workforce and ServicesOrganization and AdministrationHealth Services AdministrationPandemic PreparednessDisaster PlanningDisastersEnvironmentEnvironment and Public HealthCommunicable Disease ControlPublic Health PracticePublic Health

Limitations and Caveats

The limited duration of the study period may not allow sufficient time to show the difference in outcome measures such as self-rated health and health care utilization.

Results Point of Contact

Title
Dr. Julie Richardson
Organization
McMaster University

Study Officials

  • Julie Richardson, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 11, 2009

Study Start

May 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

June 22, 2010

Results First Posted

June 17, 2010

Record last verified: 2009-09

Locations