Condition category
Musculoskeletal Diseases
Date applied
29/08/2013
Date assigned
11/09/2013
Last edited
16/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes