Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000265875
Ethics application status
Approved
Date submitted
2/03/2012
Date registered
6/03/2012
Date last updated
6/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Remote-access physical activity support for hospital
outpatients: A four group randomised trial
Scientific title
Does participation in a remote-access physical activity behavior change intervention with either telephone, printed materials or email follow up support increase physical activity levels among hospital outpatients compared to receiving usual care?
Secondary ID [1] 280068 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 279267 0
Condition category
Condition code
Public Health 279465 279465 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This investigation includes four groups (1. printed letters support + usual care, 2. telephone support + usual care, 3. Email support + usual care, 4. Usual care only. All participants continue to receive their usual health care. No usual treatment is withheld from any participant. Each of the three intervention options (intervention 1, 2 & 3) run for a period of approximately 12 weeks commencing with a face to face motivational interview (and joint goal setting based on patient preferences to meet the prescribed physical activity requirements). This interview will be between 30 to 60 minutes duration. Following the initial interview, support is more frequent at the start (e.g. 3 support phone calls during the first week) and becomes less frequent over the remaining 11 weeks (e.g. 1 support phone call during the final fortnight). The support is provided by a suitably qualified health professional (e.g. physiotherapist or psychologist). The mode of support differs between each of the 3 intervention groups (printed letters, phone or email).
Intervention code [1] 283794 0
Lifestyle
Intervention code [2] 283795 0
Behaviour
Comparator / control treatment
Usual care provided by hospital staff
Control group
Active

Outcomes
Primary outcome [1] 286025 0
Physical activity (evaluated with accelerometers / Active Australia Survey).
Timepoint [1] 286025 0
Baseline, 6 weeks post intervention start, 12 weeks post intervention start, 26 weeks
Primary outcome [2] 286635 0
Health-related quality of life (as measured by the EQ-5D).
Timepoint [2] 286635 0
Baseline, 6 weeks post intervention start, 12 weeks post intervention start, 26 weeks
Secondary outcome [1] 295015 0
Perceived adherence to the behaviour change program activities as rated by intervention support provider on a 10cm visual analogue scale. (This is not applicable to participants in the usual care comparator group as they do not receive a behaviour change program).
Timepoint [1] 295015 0
Baseline, 6 weeks post intervention start, 12 weeks post intervention start, 26 weeks
Secondary outcome [2] 295016 0
All direct intervention costs including follow up support as measured from the perspective of the healthcare provider (e.g. cost of labour of intervention provider, telephone calls, printing, postage etc.).
Timepoint [2] 295016 0
total cost across 12 week intervention

Eligibility
Key inclusion criteria
Receiving or having recently received treatment as from a participating hospital outpatient department
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to communicate in English

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)
Consenting participants will be assigned a participant number in the order of enrollment from 1 to 106. Concealment until allocation will occur in sequentially numbered opaque envelopes (numbered from 1-106 to correspond with participant identification numbers). As each participant is assigned their identification number in order of recruitment the corresponding enveloped will be opened to reveal which of the four groups they have been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated via 4 group computerised random number generation in a ratio of 1:1:1:1 across the 4 groups.
Masking / blinding
Blinded (masking 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
Not yet recruiting
Date of first participant enrolment
Anticipated
9/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5065 0
4102

Funding & Sponsors
Funding source category [1] 284269 0
Government body
Name [1] 284269 0
Queensland Health
Country [1] 284269 0
Australia
Primary sponsor type
Individual
Name
Dr Steven McPhail
Address
Centre for Functioning and Health Research
Level 3
Centro Buranda
Ipswich Road
BURANDA QLD 4102
Country
Australia
Secondary sponsor category [1] 283701 0
Individual
Name [1] 283701 0
Mandy Schippers
Address [1] 283701 0
Centre for Functioning and Health Research
Level 3
Centro Buranda
Ipswich Road
BURANDA QLD 4102
Country [1] 283701 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286229 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 286229 0
Centres for Health Research
Level 2, Building 35
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Ethics committee country [1] 286229 0
Australia
Date submitted for ethics approval [1] 286229 0
Approval date [1] 286229 0
11/01/2012
Ethics approval number [1] 286229 0
HREC/11/QPAH/663 - SSA/11/QPAH/674

Summary
Brief summary
The aim of this investigation is to investigate three modes of supporting our outpatients to undertake the physical activity prescribed by their treating health professional (e.g. physiotherapist). This four group randomised study will investigate the merit of three modes of offering personalised support to patients (via the telephone, letters in the mail or email) in comparison to usual care.

Potential participants will be identified by their clinical team who will also provide the research team with a list suitable activities they have prescribed for their patients based on their level of fitness and any health conditions they may have. These participants will then be randomised into one of four groups. The first group will only receive their routine care and no additional support (usual care control). The second group will receive support via the telephone. The third group will receive support via letters sent in the mail. The fourth group will receive letters sent via email. The interventions will last for a period of 12 weeks. They start off with intensive support, gradually reducing to less frequent support over the 12-week period. The support is provided by a suitably qualified health professional (e.g. Physiotherapist) as prescribed by the patients usual treating team.

Data from this investigation will provide important information about the feasibility, costs and effectiveness of these interventions. This information will be used to inform future service delivery improvements and future research investigations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33447 0
Address 33447 0
Country 33447 0
Phone 33447 0
Fax 33447 0
Email 33447 0
Contact person for public queries
Name 16694 0
Dr Steven McPhail
Address 16694 0
Centre for Functioning and Health Research
PO Box 6053
Buranda QLD 4106
Country 16694 0
Australia
Phone 16694 0
+61 7 3406 2266
Fax 16694 0
Email 16694 0
[email protected]
Contact person for scientific queries
Name 7622 0
Dr Steven McPhail
Address 7622 0
Centre for Functioning and Health Research
PO Box 6053
Buranda QLD 4106
Country 7622 0
Australia
Phone 7622 0
+61 7 3406 2266
Fax 7622 0
Email 7622 0
[email protected]

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
No additional documents have been identified.