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Trial registered on ANZCTR


Registration number
ACTRN12613000730707
Ethics application status
Not yet submitted
Date submitted
17/06/2013
Date registered
2/07/2013
Date last updated
2/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of education in the self-management of elderly patients with persistent (chronic) pain.
Scientific title
A randomised controlled trial on the difference in self-management outcomes between elderly patients with persistent pain that attend pre-clinic education sessions and those that only attend a consultative pain clinic.
Secondary ID [1] 282689 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent (chronic) pain 289403 0
Condition category
Condition code
Public Health 289726 289726 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5 hours of education, over 2 sessions with in 1 week, covering subjects including: importance of self management, psychology and pain, mindfulness, acceptance, basic neurophysiology of pain, medical perspective, energy conservation and sleep, exercise/ activity and pain. THe education will be delivered by Clinical Psychologist, Rehabilitation Consultant, Physiotherapist and Occupational Therapist. The aim of the education is to shift patients paragigm towards that of self-management rather than medical management, so that patients have more insight and control in choosing options in their management. At the end of the second session patients will be asked to indicate whether they wish to have consulation within the clinic; the next available appointment will be assigned to the patient. Measurements will be made at admission, 2 weeks following initial contact and at 3 months.
Intervention code [1] 287349 0
Other interventions
Comparator / control treatment
Usual care: consisting of medical assessment, care planning and referral to other members of the multi-disciplinary team in a Pain Clinic.
Control group
Active

Outcomes
Primary outcome [1] 289818 0
Number of self-management strategies via the Pain Management Strategies Questionnaire. They will be categorised as Active-behavioural, Active-cognitive combined as 'active-strategies' and passive and passive-conventional medical combined as 'passive-strategies'.
Timepoint [1] 289818 0
2 weeks and 3 months post initial intervention.
Secondary outcome [1] 303298 0
Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [1] 303298 0
2 weeks and 3 months
Secondary outcome [2] 303561 0
Brief Pain Inventory
Timepoint [2] 303561 0
2 weeks and 3 months
Secondary outcome [3] 303562 0
Global Percieved Impression of Change (GPIC)
Timepoint [3] 303562 0
2 weeks and 3 months
Secondary outcome [4] 303563 0
Patient satisfaction questions:
1. How satified were you with the treatment you have recieved for your pain?
2. How satisfied are you with the treatmentyou have recieved for your pain prior to coming to the Pain Clinic?
3. How satisfied are you with the treatment you have recieved at the Pain Cliinic (so far)?
Timepoint [4] 303563 0
2 weeks and 3 months

Eligibility
Key inclusion criteria
Chronic pain; pain of duration equal or greater than 3 months, Aged equal or greater than 60 years, newly referred to the Pain Clinic, non-urgent, patient able to attend independently, patient able to give informed consent.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High dosage of opioids; greater than 100mg daily, severe somatic or psychiatric comorbidity, non-English speaking/ comprehension, deemed as unsuitable for group participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients screened for inclusive by posted-out questionnaire, if deemed eligible then patients will be called by phone and invited to be a particapant in the study. Allocation and randomisation will then be completed by a seperate person (Manger MONARC), in a seperate office.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Particapants will be randomised by a online random number generator available at www.randomization.com
and permuted block randomization will be used to prevent imbalance between groups.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1129 0
Kingston Centre - Cheltenham
Recruitment postcode(s) [1] 6976 0
3192 - Cheltenham
Recruitment postcode(s) [2] 6979 0
3168 - Clayton
Recruitment postcode(s) [3] 6980 0
3175 - Dandenong
Recruitment postcode(s) [4] 6981 0
3977 - Cranbourne

Funding & Sponsors
Funding source category [1] 287459 0
Charities/Societies/Foundations
Name [1] 287459 0
Lions John Cockayne Memorial Fellowship Trust Fund
Country [1] 287459 0
Australia
Primary sponsor type
University
Name
MONARC, Monash University
Address
Monash University
Victoria 3800
Country
Australia
Secondary sponsor category [1] 286203 0
None
Name [1] 286203 0
Address [1] 286203 0
Country [1] 286203 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289434 0
Southern Health HREC A
Ethics committee address [1] 289434 0
Research Directorate,
Level 4, Main Block,
Monash Medical Centre,
246 Clayton Road,
Clayton 3168 VICTORIA
Ethics committee country [1] 289434 0
Australia
Date submitted for ethics approval [1] 289434 0
19/06/2013
Approval date [1] 289434 0
Ethics approval number [1] 289434 0

Summary
Brief summary
The aim of the research is to compare the established prectice of the Pain Clinic versus this intervention, consisiting of 5 hours of education to promote self management in persistent pain conditions. The study will be one of a randomised controlled trial pilot design; 2 care pathways; firstly usual care where patients will be assessed by a doctor and other allied health professionals. The intervention will be the education sessions followed by the option of patients attending clinic for consultations with the doctor and other health care professionals. The study will look at the research questions:
1. To see if pre-clinic education is a significant improved model of care compared with usual care,
2. To see the interaction between education sessions and medial intervention,
3. To monitor the changes in patients self management over time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40842 0
Mr Marcus Bowler
Address 40842 0
Kingston Centre Pain Service,
Monash Health,
Kingston Centre,
Warrigal Road,
Cheltenham 3192
VICTORIA
Country 40842 0
Australia
Phone 40842 0
+61 3 9295 1401
Fax 40842 0
Email 40842 0
[email protected]
Contact person for public queries
Name 40843 0
Marcus Bowler
Address 40843 0
Kingston Centre Pain Service,
Monash Health,
Kingston Centre,
Warrigal Road,
Cheltenham 3192
VICTORIA
Country 40843 0
Australia
Phone 40843 0
+61 3 9265 1401
Fax 40843 0
Email 40843 0
[email protected]
Contact person for scientific queries
Name 40844 0
Marcus Bowler
Address 40844 0
Kingston Centre Pain Service,
Monash Health,
Kingston Centre,
Warrigal Road,
Cheltenham 3192
VICTORIA
Country 40844 0
Australia
Phone 40844 0
+61 3 9265 1401
Fax 40844 0
Email 40844 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

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