ANZCTR - Registration

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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]

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.

Condition category

Condition code

Cardiovascular

Coronary heart disease

Metabolic and Endocrine

Diabetes

Respiratory

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]

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]

Change in self efficacy (Stanford Self Efficacy for Managing Chronic Disease 6 Item Scale)

Timepoint [1]

Measured at baseline and 4 months follow up

Primary outcome [2]

Change in self management knowledge and behaviour (Scales developed & previously piloted for the specific purposes of the trial)

Timepoint [2]

Measured at baseline and 4 months follow up

Primary outcome [3]

Improvement in perceived health status (Stanford Self Rated Health Scale)

Timepoint [3]

Measured at baseline and 4 months follow up

Secondary outcome [1]

Improvement in work and social adjustment scores (Work and Social Adjustment Scale)

Timepoint [1]

Measured at baseline and 4 months follow up

Secondary outcome [2]

Greater knowledge concerning use of medicines (Scale developed & previously piloted for the specific purposes of the trial)

Timepoint [2]

Measured at baseline and 4 months follow up

Secondary outcome [3]

Improvement in anxiety and depression scores (Hospital Anxiety and Depression Scale)

Timepoint [3]

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

Sex

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

15/06/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Arthritis NSW

Address [1]

Locked Bag 16
Post Office North Parramatta
North Parramatta NSW 2151

Country [1]

Australia

Funding source category [2]

Other

Name [2]

National Prescribing Service

Address [2]

PO Box 1147
Strawberry Hills, NSW 2012

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Arthritis NSW

Address [1]

Locked Bag 16
Post Office North Parramatta
North Parramatta NSW 2151

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney West Area Health Service Human Research Ethics Committee, Westmead Campus

Ethics committee address [1]

Research Office, Room 2020 Clinical Sciences
Westmead Hospital, Hawkesbury Road, Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

07/04/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Anna Williams

Address

Centre for Primary Health Care and Equity
University of New South Wales
Kensington NSW 2052
Australia

Country

Australia

Phone

61 2 93851504

Fax

61 2 93851513

Email

a.williams@unsw.edu.au

Contact person for scientific queries

Name

Mark Harris

Address

Centre for Primary Health Care and Equity
University of New South Wales
Kensington NSW 2052
Australia

Country

Australia

Phone

61 2 93851547

Fax

61 2 93851513

Email

m.f.harris@unsw.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Effectiveness of moving on: an Australian designed generic self-management program for people with a chronic illness	2013	https://doi.org/10.1186/1472-6963-13-90

N.B. These documents automatically identified may not have been verified by the study sponsor.