Condition category
Musculoskeletal Diseases
Date applied
24/06/2008
Date assigned
21/08/2008
Last edited
20/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Maria Crotty

ORCID ID

Contact details

Department of Rehabilitation and Aged Care
Flinders University
GPO Box 2100
Adelaide
5001
Australia
+61 (0)8 8275 1103
maria.crotty@flinders.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.06

Study information

Scientific title

A randomised controlled trial to determine the effectiveness of chronic disease self management in people with osteoarthritis awaiting joint replacement surgery to improve their health related quality of life

Acronym

Study hypothesis

The management of disability of patients on joint replacement waiting lists will be improved through the introduction of a regional Partners in Health model promoting self management supported by a telephone call-centre.

Ethics approval

Ethics approval received from:
1. The Flinders Clinical Research Ethics Committee on the 27th July 2005
2. The Repatriation General Hospital Research and Ethics Committee on the 17th August 2005 (ref: 36/05)

Study design

Interventional, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Osteoarthritis

Intervention

Partners in Health chronic disease self management is a clinician focused approach which provides health professionals with the tools to work in partnership with individuals with chronic illness to maximise their self management capacity. The generic patient-centred assessment using a Partners in Health scale, Cue and Response interview and Problems/goal identification results in a care plan that describes which services and self-management goals will be addressed over a 6-month period. Partners in Health will be linked to a telephone support system manned by trained non-medical personnel (and managed by Arthritis South Australia).

Participants allocated to the control group received the usual standard of care for patients on orthopaedic waiting lists. Participants in the control group were able to access the "Moving Towards Wellness" course run by Arthritis SA (as is the case for all people who are added to the orthopaedic waiting list). Participants in the control group did not receive any additional educational material.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Health education impact was measured using the Health Education Impact Questionnaire (HEI-Q) at baseline and six months.

Secondary outcome measures

1. Quality of life, measured using the Assessment of Quality of Life (AQoL), at baseline and six months
2. Depression, measured using the Centre for Epidemiological Studies Depression Scale (CES-D) at baseline and six months
3. Medications beliefs were measured using the Beliefs about Medicines which is a patient-centred measure that captures individual’s general beliefs about use of prescription and non-prescription medicines, at baseline and six months
4. The Western Ontario and McMaster Universities (WOMAC) Arthritis Index was used to capture the pain, stiffness and function associated with osteoarthritis at baseline and six months

Overall trial start date

03/10/2005

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed allocation as non-urgent status to a southern region
2. Joint replacement waiting list
3. Adult patients, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

1. Mini-mental state examination score less than 24
2. Unable to read and speak English
3. Unable to complete the six-month follow-up
4. Significant frailty or illness that will make protocol completion unlikely
5. Living outside the southern region of Adelaide
6. Urgent or semi-urgent category status

Recruitment start date

03/10/2005

Recruitment end date

31/05/2008

Locations

Countries of recruitment

Australia

Trial participating centre

Department of Rehabilitation and Aged Care
Adelaide
5001
Australia

Sponsor information

Organisation

Flinders University (Australia)

Sponsor details

c/o Professor Maria Crotty
Department of Rehabilitation and Aged Care
GPO Box 2100
Adelaide
5001
Australia
+61 (0)8 8275 1103
maria.crotty@flinders.edu.au

Sponsor type

University/education

Website

http://www.flinders.edu.au/

Funders

Funder type

Research organisation

Funder name

Arthritis and Musculoskeletal Quality Improvement Program (AMIQuIP) (Australia) (ref: 1.06)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results on http://www.ncbi.nlm.nih.gov/pubmed/19486959

Publication citations

  1. Results

    Crotty M, Prendergast J, Battersby MW, Rowett D, Graves SE, Leach G, Giles LC, Self-management and peer support among people with arthritis on a hospital joint replacement waiting list: a randomised controlled trial., Osteoarthr. Cartil., 2009, 17, 11, 1428-1433, doi: 10.1016/j.joca.2009.05.010.

Additional files

Editorial Notes