Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861989
Recruitment Status : Unknown
Verified July 2016 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.


Condition or disease Intervention/treatment
Osteoporosis Other: qualitative study

Layout table for study information
Study Type : Observational
Actual Enrollment : 114 participants
Time Perspective: Cross-Sectional
Official Title: Qualitative Study on Representations of Osteoporosis in the General and At-risk Population and in General Practitioners.
Study Start Date : February 2014
Actual Primary Completion Date : January 2015
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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


  2. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
women aged 50 to 85 years and men aged 60 to 85 years, and general practitioners.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861989


Locations
Layout table for location information
France
Pôle IMER, Hospices Civils de Lyon
Lyon, France, 69424
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Anne-Marie Schott, Pr Hospices Civils de Lyon
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02861989    
Other Study ID Numbers: 69HCL16_0499
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
osteoporosis
prevention
care management
focus groups
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases