Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000263796
Ethics application status
Not yet submitted
Date submitted
4/03/2013
Date registered
6/03/2013
Date last updated
6/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Patient Understanding About Osteoporosis Be Improved?

Scientific title
in patients with osteoporosis, does showing patients models (3D plastic models) of osteoporotic and normal bones compared to a verbal explanation of osteoporosis improve patient illness beliefs and their intentions to engage in treatment
Secondary ID [1] 282057 0
Nil known
Universal Trial Number (UTN)
U1111-1137-4978
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoporosis 288536 0
Condition category
Condition code
Musculoskeletal 288870 288870 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
participants (patients attending a single 20 minute consultation with an endocrinologist where they have a bone density scan and are told they have osteoporosis) in the intervention group will be shown two 3D plastic bone models during this consultation. One will be of a healthy bone and the other model will be of an osteoporotic bone. These models will be used by the endocrinologist to demonstrate the difference between a healthy bone and a normal bone; to show how osteoporotic bones are more porous and brittle and more likely to fracture.
Intervention code [1] 286654 0
Other interventions
Comparator / control treatment
Participants in the control group (patients attending a single 20 minute consultation with an endocrinologist where they have a bone density scan and are told they have osteoporosis) will receive a verbal explanation of what osteoporosis is.
Control group
Active

Outcomes
Primary outcome [1] 288999 0
Participants intentions to take medication for osteoporosis and perform health behaviours as recomended by an endocrinologist. This will be assessed in a questionnaire by asking the participants the following question which they will rate on a scale of 1-10 from not likely to extremely likely. "What are your intentions to engage in the following health behaviours to improve your bone health?" this will be asked for the following health behaviours:

- Diet – eating food high in calcium
- Managing your stress
- Exercising regularly
- Taking medications that may be recommended by your doctor
- Taking calcium supplements
- Taking vitamin D supplements
Timepoint [1] 288999 0
20 minutes after consultation
Secondary outcome [1] 301538 0
Brief Illness Perception Questionnaire (BIPS) score
Timepoint [1] 301538 0
20 minutes after consultation

Eligibility
Key inclusion criteria
meets the criteria for pharmacological treatment promoted by the National Osteoporosis Foundation
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
are unable to speak,. write and read english
are unable to give informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4896 0
New Zealand
State/province [1] 4896 0
Auckland

Funding & Sponsors
Funding source category [1] 286833 0
University
Name [1] 286833 0
The University of Auckland
Country [1] 286833 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland
New Zealand
1010
Country
New Zealand
Secondary sponsor category [1] 285623 0
None
Name [1] 285623 0
Address [1] 285623 0
Country [1] 285623 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288899 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 288899 0
Ethics committee country [1] 288899 0
New Zealand
Date submitted for ethics approval [1] 288899 0
19/12/2012
Approval date [1] 288899 0
Ethics approval number [1] 288899 0

Summary
Brief summary
The aim of the study is to determine whether visualising and interacting with 3D models of a healthy and osteoporotic bone helps patients better understand osteoporosis and hold greater intentions to take their medication compared to receiving verbal information about osteoporosis.

To do this, patients who are attending the School of Medicine Clinical Research Centre and have confirmed osteoporosiss are being asked to participate in the study. Participants will be randomly allocated to either the intervention or control group.

It is hypothesised that participants who receive the bone models in their consultation will gain a better understanding of osteoporosis, form better beliefs regarding this illness, and have better intentions to engage in treatment compared to the patients who just receive the verbal description of osteoporosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38210 0
Prof Keith Petrie
Address 38210 0
Private Bag 92019 Auckland New Zealand OR room 12.003 Level 12 Hospital Support Building Auckland City Hospital Auckland 1010
Country 38210 0
New Zealand
Phone 38210 0
+64 9 373 7599 extn 86564
Fax 38210 0
Email 38210 0
kj.petrie@auckland.ac.nz
Contact person for public queries
Name 38211 0
Prof Keith Petrie
Address 38211 0
Private Bag 92019 Auckland New Zealand OR room 12.003 Level 12 Hospital Support Building Auckland City Hospital Auckland 1010
Country 38211 0
New Zealand
Phone 38211 0
+64 9 373 7599 extn 86564
Fax 38211 0
Email 38211 0
kj.petrie@auckland.ac.nz
Contact person for scientific queries
Name 38212 0
Prof Keith Petrie
Address 38212 0
Private Bag 92019 Auckland New Zealand OR room 12.003 Level 12 Hospital Support Building Auckland City Hospital Auckland 1010
Country 38212 0
New Zealand
Phone 38212 0
+64 9 373 7599 extn 86564
Fax 38212 0
Email 38212 0
kj.petrie@auckland.ac.nz

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.