To determine if a peer-education model can improve the management of osteoporosis in community dwelling seniors

ISRCTN ISRCTN44810824
DOI https://doi.org/10.1186/ISRCTN44810824
Secondary identifying numbers N/A
Submission date
29/08/2013
Registration date
11/09/2013
Last edited
16/09/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Marita Kloseck
Scientific

The University of Western Ontario
Faculty of Health Sciences
London
N6A 5C1
Canada

Email mkloseck@uwo.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised trial to determine if a peer-education model can improve the management of osteoporosis in community dwelling seniors
Study objectivesIt 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(s)University of Western Ontario Research Ethics Board for Health Sciences, June 8, 2007, Research Number 12835E
Health condition(s) or problem(s) studiedOsteoporosis
InterventionA 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 typeOther
Primary outcome measureThe 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 measuresNo secondary outcome measures
Overall study start date07/06/2008
Completion date30/09/2009

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants100
Key inclusion criteriaAged 65 or over, either gender, living within the Cherryhill apartment complex
Key exclusion criteriaInability to speak English
Date of first enrolment07/06/2008
Date of final enrolment30/09/2009

Locations

Countries of recruitment

  • Canada

Study participating centre

The University of Western Ontario
London
N6A 5C1
Canada

Sponsor information

Proctor and Gamble Pharmaceuticals Inc (Canada)
Industry

4711 Yonge Street
Toronto
M2N 6K8
Canada

Phone +1 519 685 4021
Email rcrilly@uwo.ca
ROR logo "ROR" https://ror.org/04rcgpb63

Funders

Funder type

Industry

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan