Plain English Summary
Background and study aims
Osteoporosis is a condition whereby the bones have lost strength and are at increased risk of fracture. It is well known to be underdiagnosed and undertreated. There are medications available that can significantly reduce the rate of fracturing but they are underused. The decision to treat is usually based on a fracture history and risk assessment, for example by measuring the bone mineral density (a measure of bone strength). The aim of this study was to test an educational model whereby a group of specially educated older peers could educate other seniors about the disease, its assessment and management, and assist them to navigate the healthcare system to get an assessment done and be placed on appropriate treatment by discussing the risk state with their family doctor.
Who can participate?
The study will be conducted in a limited geographic area in London Ontario, consisting of 13 apartment blocks with a high number of seniors. Anyone at or over the age of 65 and who is a resident of that community, can participate.
What does the study involve?
Participants will be randomly allocated to the intervention or the control group. Participants in the control group will receive usual care. Participants in the intervention group will attend a 2-hour education session presented by their peers, following which they will be assigned a monitor who will conduct a fracture risk assessment, encourage the subject to approach their doctor to obtain a bone mineral density (BMD) measurement, and with the result of the fracture risk assessment along with the BMD return to the physician for a final assessment on the need for treatment. The study will assess how many are successful at completing the assessment and being put on the appropriate medication.
What are the possible benefits and risks of participating?
The subjects may benefit from improvement in the management of their risk assessment if appropriate. There are no anticipated risks.
Where is the study run from?
At the University of Western Ontario, London, Ontario, Canada.
When is the study starting and how long is it expected to run for?
The study started in June 2008 and completed in September 2009.
Who is funding the study?
The study is funded by an unrestricted grant from the Alliance for Better Bone Health, an initiative of Procter and Gamble Pharmaceuticals.
Who is the main contact?
Dr Richard Crilly, Department of Medicine, University of Western Ontario.
Dr Marita Kloseck, mkloseck@uwo.ca
Trial website
Contact information
Type
Scientific
Primary contact
Prof Marita Kloseck
ORCID ID
Contact details
The University of Western Ontario
Faculty of Health Sciences
London
N6A 5C1
Canada
mkloseck@uwo.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised trial to determine if a peer-education model can improve the management of osteoporosis in community dwelling seniors
Acronym
Study hypothesis
It is hypothesised that an education and mentoring model involving a small group of educated peer-mentors can increase the appropriate assessment and management of osteoporosis in a community of seniors.
Ethics approval
University of Western Ontario Research Ethics Board for Health Sciences, June 8, 2007, Research Number 12835E
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Osteoporosis
Intervention
A small group of six senior volunteers will be educated regarding osteoporosis, its assessment and management. They will then educate their peers regarding the disease and its assessment and management. Each subject is assigned a mentor who will conduct a fracture risk assessment.
The control was "usual care".
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The proportion of subjects who complete the process and receive appropriate management. The outcomes were recorded at baseline and 6 months.This was by patient interview with their mentor who recorded the patient's progress through the system. The nature of the study was a one on one mentor and patient relationship so progress through the system was continually monitored and advice offered if problems arose. The final assessment was at 6 months.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
07/06/2008
Overall trial end date
30/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Aged 65 or over, either gender, living within the Cherryhill apartment complex
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
100
Participant exclusion criteria
Inability to speak English
Recruitment start date
07/06/2008
Recruitment end date
30/09/2009
Locations
Countries of recruitment
Canada
Trial participating centre
The University of Western Ontario
London
N6A 5C1
Canada
Sponsor information
Organisation
Proctor and Gamble Pharmaceuticals Inc (Canada)
Sponsor details
4711 Yonge Street
Toronto
M2N 6K8
Canada
+1 519 685 4021
rcrilly@uwo.ca
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
An unrestricted grant from the Alliance for Better Bone Health, an initiative of Proctor and Gamble Pharmaceuticals (bought out by Warner Chilcott after the funding) (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list