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Trial registered on ANZCTR


Registration number
ACTRN12609000298213
Ethics application status
Approved
Date submitted
16/04/2009
Date registered
18/05/2009
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of "Moving On", a self management program for people with a chronic illness, on participants' self management knowledge, self efficacy and lifestyle behaviours.
Scientific title
A randomised controlled trial of "Moving On", a self management program for people with a chronic illness: Impact on participants' self management knowledge, self efficacy and lifestyle behaviours.
Secondary ID [1] 842 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease, Diabetes, Respiratory Illnesses, Asthma. 4787 0
Condition category
Condition code
Cardiovascular 4904 4904 0 0
Coronary heart disease
Metabolic and Endocrine 4905 4905 0 0
Diabetes
Respiratory 4906 4906 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Moving On Program Participants
The Program is based on the transtheoretical framework of the stages of change and principles of adult learning. Participants will receive one 3 hour session per week for seven weeks in total duration. The sessions will be delivered by two trained leaders, a health care professional and a lay leader. Topics covered include: (1) An introductory session reviewing the content of the program; (2)Managing fatigue and physical activity; (3)Healthy eating and fatigue; (4)Coping with a chronic illness; (5)Stress management and relaxation and getting a good nights sleep; (6)Getting the most out of your medicines and working with your health care team; (7) Putting it all together, personal action plans or self management review and evaluation.
Intervention code [1] 4369 0
Other interventions
Comparator / control treatment
Control Program Participants
Participants of the control program will receive seven 1 hour weekly light exercise sessions delivered by a leader who has undergone training to administer the program.
Control group
Active

Outcomes
Primary outcome [1] 5751 0
Change in self efficacy (Stanford Self Efficacy for Managing Chronic Disease 6 Item Scale)
Timepoint [1] 5751 0
Measured at baseline and 4 months follow up
Primary outcome [2] 5752 0
Change in self management knowledge and behaviour (Scales developed & previously piloted for the specific purposes of the trial)
Timepoint [2] 5752 0
Measured at baseline and 4 months follow up
Primary outcome [3] 5753 0
Improvement in perceived health status (Stanford Self Rated Health Scale)
Timepoint [3] 5753 0
Measured at baseline and 4 months follow up
Secondary outcome [1] 241703 0
Improvement in work and social adjustment scores (Work and Social Adjustment Scale)
Timepoint [1] 241703 0
Measured at baseline and 4 months follow up
Secondary outcome [2] 241704 0
Greater knowledge concerning use of medicines (Scale developed & previously piloted for the specific purposes of the trial)
Timepoint [2] 241704 0
Measured at baseline and 4 months follow up
Secondary outcome [3] 241705 0
Improvement in anxiety and depression scores (Hospital Anxiety and Depression Scale)
Timepoint [3] 241705 0
Measured at baseline and 4 months follow up

Eligibility
Key inclusion criteria
Consumers are eligible to join the study if (1) they are aged between 45-75yrs; (2) were not recently diagnosed with a chronic illness (provider determined); (3) have a reasonable understanding of their chronic ilness (provider determined); (4)are able to speak, write and understand english (provider determined); (5)agree to attend group education sessions (provider determined).
Minimum age
45 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Consumers are not eligible to join the study if (1) they have been diagnosed with a severe mental illness (excluding depression and anxiety); (2) they have cognitive impairment issues including dementia; (3)they have substance abuse issues; (4) they are unable to participate in light physical activity.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The research team will work collaboratively with participating Area Health Services and Divisions of General Practice to identify a broad range of health care providers to engage in the study by way of referring their patients to the study. The health care providers will receive education about the purposes of the study and the client recruitment procedure including written material on eligibility of clients for participation in the study and copies of the referral form. In addition to health care providers identifying potential participants, the study will be advertised widely in local newspapers and through distribution of a study brochure and referral form in the waiting rooms of health care providers, community noticeboards. Those persons that respond to the local advertisements and promotion of the study will need to seek a referral from their health care provider on their next subsequent visit.
Enrollment of consumers in the study has five steps: (1) On receipt of the referral form, a study participation package will be sent to the consumer from UNSW. The study participation package will include a participant information and consent form, the baseline evaluation survey and a pre-paid self addressed envelope; (2) The consumer will be asked to complete the Consent Form as well as the baseline survey and return these documents to UNSW using the supplied pre paid self addressed enveloope; (3) Receipt of the Consent Form and the baseline survey by UNSW completes the enrollment process of the consumer to the study; (4) Once enrollment has taken place, the consumer will be randomly allocated (block allocation)by central randomisation by computer program to either the intervention or control program; (5) The consumer will then be notified by a member of the research team regarding which program they have been allocated to and details concerning the date, starting time and location of the Program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4791 0
Charities/Societies/Foundations
Name [1] 4791 0
Arthritis NSW
Address [1] 4791 0
Locked Bag 16
Post Office North Parramatta
North Parramatta NSW 2151
Country [1] 4791 0
Australia
Funding source category [2] 4792 0
Other
Name [2] 4792 0
National Prescribing Service
Address [2] 4792 0
PO Box 1147
Strawberry Hills, NSW 2012
Country [2] 4792 0
Australia
Primary sponsor type
University
Name
University of New South wales
Address
Centre for Primary Health Care and Equity
University of New South Wales
Kensington NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 4487 0
None
Name [1] 4487 0
Address [1] 4487 0
Country [1] 4487 0
Other collaborator category [1] 643 0
Charities/Societies/Foundations
Name [1] 643 0
Arthritis NSW
Address [1] 643 0
Locked Bag 16
Post Office North Parramatta
North Parramatta NSW 2151
Country [1] 643 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6839 0
Sydney West Area Health Service Human Research Ethics Committee, Westmead Campus
Ethics committee address [1] 6839 0
Research Office, Room 2020 Clinical Sciences
Westmead Hospital, Hawkesbury Road, Westmead NSW 2145
Ethics committee country [1] 6839 0
Australia
Date submitted for ethics approval [1] 6839 0
Approval date [1] 6839 0
07/04/2009
Ethics approval number [1] 6839 0

Summary
Brief summary
This research study seeks to evaluate the effectiveness of a generic chronic disease self management program by
implementing a randomised control trial. A pre-test and pilot study have previously been completed. The trial will be
conducted in Sydney West Area Health Service. The research study will be undertaken collaboratively with the local
area health service and Divisions of General Practice. Expression of Interests will be sought from a wide range of
health care providers (GPs, clinicians working for the Area Health Service, Outpatient Department clinicians,
community health and primary health care nurses, public and private allied health clinicians) to refer patients/clients
based on an eligibility criteria to the study. The participating health care professionals will receive briefing on the
referral process and be required to sign a consent form to participate. On referral, patients/clients will receive a study
package containing information about the study, consent form and baseline survey. Return of the consent form and
baseline survey by the patient/client will constitute enrollment in the study. At this point patient/clients will be allocated
randomly to either participation in the intervention group (generic chronic disease self management program) or the
control program (light physical activity program). Patients/clients who enrol in the study will be requested to complete a
self administered questionnaire before and at 4 months post program attendance, to assess outcomes associated with
attending the program. In addition, participants attending the generic chronic disease self managemet program will be
requested to complete a process evaluation survey at the end of the first session and on completion of the program.
Trial website
Trial related presentations / publications
Williams Anna, Harris Mark, Aspinall Diana, Bloomfield Leah, Orr Neil, Donnelly Neil, Filocamo Karen, Vajda Jacqualine. Pilot Study: Moving On. UNSW Research Centre for Primary Health Care and Equity, UNSW, March 2009.
Public notes

Contacts
Principal investigator
Name 29495 0
Address 29495 0
Country 29495 0
Phone 29495 0
Fax 29495 0
Email 29495 0
Contact person for public queries
Name 12742 0
Anna Williams
Address 12742 0
Centre for Primary Health Care and Equity
University of New South Wales
Kensington NSW 2052
Australia
Country 12742 0
Australia
Phone 12742 0
61 2 93851504
Fax 12742 0
61 2 93851513
Email 12742 0
a.williams@unsw.edu.au
Contact person for scientific queries
Name 3670 0
Mark Harris
Address 3670 0
Centre for Primary Health Care and Equity
University of New South Wales
Kensington NSW 2052
Australia
Country 3670 0
Australia
Phone 3670 0
61 2 93851547
Fax 3670 0
61 2 93851513
Email 3670 0
m.f.harris@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary