OsteoporosisQUALIOPNCT02861989
Qualitative Study on Osteoporosis Representation and Management in the General Population and in General Practitioners.
An observational study of Osteoporosis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- qualitative study
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: women aged 50 to 85 years and men aged 60 to 85 years, and general practitioners.
Who may be able to join
- 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
Who cannot join
- no signed consent
- legal disability
- difficulty in understanding French
- psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Osteoporosis
- Being tested
- qualitative study
- Keywords
- osteoporosis, prevention, care management, focus groups
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative studyOther
| Study group | Role | What they receive |
|---|---|---|
| Osteoporotic women | women over 50 years with a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment Receives: Other: qualitative study | |
| At risk women | women over 50 years without a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment Receives: Other: qualitative study | |
| Osteoporotic men | Men over 60 years with a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment Receives: Other: qualitative study | |
| At-risk men | Men over 60 years without a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment Receives: Other: qualitative study | |
| General practitioners | General practitioners from the Rhône area, France Receives: Other: qualitative study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (2)
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
Measured: At the day of inclusion
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
Measured: At the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Marie Schott, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861989
- Sponsor's protocol ID
- 69HCL16_0499
- Acronym
- QUALIOP
- Status last verified
- Jul 2016
- First submitted
- 2 Aug 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Study on Representations of Osteoporosis in the General and At-risk Population and in General Practitioners.
- ClinicalTrials.gov ID
- NCT02861989
- Acronym / sponsor ID
- QUALIOP / 69HCL16_0499
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, prevention, care management, focus groups
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2017 (estimated)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Osteoporotic women | – | Other: qualitative studywomen over 50 years with a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment |
| At risk women | – | Other: qualitative studywomen over 50 years without a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment |
| Osteoporotic men | – | Other: qualitative studyMen over 60 years with a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment |
| At-risk men | – | Other: qualitative studyMen over 60 years without a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment |
| General practitioners | – | Other: qualitative studyGeneral practitioners from the Rhône area, France |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women aged 50 to 85 years and men aged 60 to 85 years, and general practitioners.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- no signed consent
- legal disability
- difficulty in understanding French
- psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qualitative study | Other | At risk women, At-risk men, General practitioners, Osteoporotic men, Osteoporotic women |
Primary outcome
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
2 secondary outcomes
Factors favoring and barriers to a better management of OP in each group
Time frame: At the day of inclusion
Specific communication needs for the different groups: men/women, fractured/non-fractured.
Time frame: At the day of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Marie Schott, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focus Group Interview (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.