Psychological Determinants of the Therapeutic Observance of Osteoporotic Patients

NCT04029870 | Completed

• 1 other identifier: 2019-02Obs-CHRMT
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporosis is a skeletal pathology characterized by decreased bone mass and deterioration of bone tissue. This pathology affects predominantly women, which is estimated that 40% of them will suffer an osteoporotic fracture. The incidence of osteoporosis, thus representing a major public health problem where osteoporotic fractures have a higher incidence than those combined with cardiovascular disease and breast cancer (INSERM, 2016; WHO 2008). It causes traumatic fractures that have the effect of dependence and loss of functional autonomy associated, in terms, with the risk of a reduction in life expectancy. The management of osteoporosis therefore becomes an issue for rheumatologists. The latter involves both compliance with hygienic-Dietetic measures (such as calcium intake, physical activities, prevention of falls...) and medicated treatments whose action is intended, for some, to block bone destruction or, for others to stimulate bone formation. The efficacy of drug treatments is now proven, these treatments are however profitable only if the therapeutic adherence of the patients is maximal. However, rheumatologists and researchers generally find an average rate of 70% enrolment after 6 months of treatment, most often lowered to 50% after 12 months of treatment, thus increasing fractures. On the other hand, the literature informs the medical and educational aspects of the problem of non-observance in osteoporotic patients, but curiously, it does not say anything of the psychological aspects likely to be linked to these behaviors of non-adherence to therapy. The objective of this thesis work is to take an interest in the underlying psychological determinants that may explain the behaviour of adherence and/or non-adherence of osteoporotic patients.

Conditions

Osteoporosis, Postmenopausal

Keywords

Osteoporosis; adherence to therapy; psychological determinants; self regulation model

Outcome Measures

Primary Outcomes (1)

• Adherence to therapy

  The influence of psychological emission on the therapeutic adherence is measured with an adherence scale (EGOMAC) which includes 3 items: drugs observance, hygiene compliance and dietary restrictions. The item are scored on a 4-point scale with 1-strongly disagree; 2-disagree, 3-agree and 4-fully agree.

  Day 1

Secondary Outcomes (4)

• Adherence to therapy

  Year 1

• Perception of disease

  day 1

• Perception of treatment

  day 1

• Anxiety

  day 1

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Patients with post-menopausal osteoporosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will focus on a sample of 200 post-menopausal osteoporotic patients.

You may qualify if:

• Be treated with an anti-osteoporotic drug for at least three months
• Mastering the French language orally and in writing
• Have obtained the patient's oral agreement to participate in the research
• Present post-menopausal osteoporosis
• Present a densitometric osteoporosis with a T-score (-2.5) treated medically per OS (example: biphosphonates) or by subcutaneous injection (example: prolia)
• Present a history of severe osteoporotic fractures after falls of its height.

You may not qualify if:

• Present a psychiatric history
• Present an intellectual disability
• Present major cognitive disorders related to neurodegenerative disease or other nervous system disorders.

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz Thionville

Metz, Moselle, 57085, France

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: June 17, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

FR (1)