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

Osteoporosis Clinical Trial

— QUALIOP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02861989
• Other study ID #: 69HCL16_0499
• Status: Active, not recruiting
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 5, 2016
• Start date: February 2014
• Est. completion date: February 2017

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: February 2017
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• qualitative study

Locations

Country	Name	City	State
France	Pôle IMER, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Focus Group Interview	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	No
Secondary	Factors favoring and barriers to a better management of OP in each group	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	No
Secondary	Specific communication needs for the different groups: men/women, fractured/non-fractured.	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	No