Qualitative Study on Osteoporosis Representation and Management in the General Population and in General Practitioners. (QUALIOP)

August 5, 2016 updated by: Hospices Civils de Lyon

Qualitative Study on Representations of Osteoporosis in the General and At-risk Population and in General Practitioners.

Osteoporosis (OP) and subsequent fractures (OP fractures) are a source of morbidity and high mortality in the elderly. Despite numerous programs aiming at improving OP care, the prevention, diagnostic and treatment remain suboptimal. Barriers to a better care are multiple, both in the general and at-risk population, and in medical practitioners. Since they do not perceive their susceptibility to OP, people do not see the benefit of prevention. In addition, physicians do not give sufficient importance to OP prevention and care, despite the existence of guidelines.

The investigators implemented a qualitative study to explore the knowledge and representations regarding osteoporosis in the general and at-risk population and in doctors in Rhône-Alpes Region, France, using focus groups with women and men and semi-structured face-to-face interviews with general practitioners. Understanding barriers to osteoporosis care in patients and general practitioners will help to set up effective strategies to improve prevention and treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69424
        • Pôle IMER, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

women aged 50 to 85 years and men aged 60 to 85 years, and general practitioners.

Description

Inclusion Criteria:

  • group 1: women aged 50 to 85 years with a history of fragility fracture or an osteoporosis diagnostic
  • group 2: women aged 50 to 85 years without a history of fragility fracture or an osteoporosis diagnostic
  • group 3: men aged 60 to 85 years with a history of fragility fracture or an osteoporosis diagnostic
  • group 4: men aged 60 to 85 years without a history of fragility fracture or an osteoporosis diagnostic
  • group 5: general practitioners in Region Rhône-Alpes, France
  • who signed the consent form

Exclusion Criteria:

  • no signed consent
  • legal disability
  • difficulty in understanding French
  • psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Osteoporotic women
women over 50 years with a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment
Other: qualitative study
At risk women
women over 50 years without a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment
Other: qualitative study
Osteoporotic men
Men over 60 years with a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment
Other: qualitative study
At-risk men
Men over 60 years without a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment
Other: qualitative study
General practitioners
General practitioners from the Rhône area, France
Other: qualitative study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focus Group Interview
Time Frame: 24 hours

Representations of osteoporosis, in general practitioners and in 4 groups of people.

Representations were drawn from focus groups interviews based on the theory of social representations of illness developed by Moscovici and Durkheim. Four types of focus groups were conducted until data saturation: 9 groups with women aged 50 to 85 years and 7 groups with men aged 60 to 85 years, with or without a history of fragility fracture or an osteoporosis diagnostic.

In parallel, semi-structured face-to face interviews were conducted with 16 general practitioners
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors favoring and barriers to a better management of OP in each group
Time Frame: At the day of inclusion

Factors favoring and barriers to a better management of OP were collected during the focus groups interviews. Specific questions were asked to collect information on reasons for not complying with recommendations or prescriptions. Four types of focus groups were conducted until data saturation: 9 groups with women aged 50 to 85 years and 7 groups with men aged 60 to 85 years, with or without a history of fragility fracture or an osteoporosis diagnostic.

In parallel, semi-structured face-to face interviews were conducted with 16 general practitioners
At the day of inclusion
Specific communication needs for the different groups: men/women, fractured/non-fractured.
Time Frame: At the day of inclusion

Needs for communication tools were collected by specific questions asked during the focus groups interviews. Four types of focus groups were conducted until data saturation: 9 groups with women aged 50 to 85 years and 7 groups with men aged 60 to 85 years, with or without a history of fragility fracture or an osteoporosis diagnostic.

In parallel, semi-structured face-to face interviews were conducted with 16 general practitioners
At the day of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Anne-Marie Schott, Pr, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0499

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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