An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective

Istanbul University

Status: Not yet enrolling

Conditions: Osteoporosis; Medication Adherence; Osteoporotic Fractures; Psychosocial Functioning

Study type: Observational

Funder types: Other

Identifiers

NCT05943600

OPKO-1

Details and patient eligibility

About

This observational study aims to learn about the psychosocial risk factors of osteoporosis (OP) patients. The main question it aims to answer is:

• Which biopsychosocial factors affect OP patients' fragility fracture risk regarding the health behaviour model? Participants will fulfil these forms below here;
• Sociodemographic and Clinical Information Form,
• Fragility Fracture Information Form
• Medication Adherence Report Scale
• Brief Illness Perception Scale
• The Beliefs About the Medicines Scale-Specific
• The Short Assessment of Patient Satisfaction
• Perceived Stress Scale
• Multidimensional Perceived Social Support Scale
• Brief Symptom Inventory - Depression and Anxiety
• Health Behavior Assessment Scale

Full description

Osteoporosis (OP) is a disease characterized by decreased bone density and deterioration of bone microarchitecture. Fracture risk, which is one of the most negative disease experiences faced by OP patients, can be seen in many parts of the body in the later stages of the disease. The necessity of interventions that prevent or delay fractures highlights severe orthopaedic surgeries, increasing health expenditures and psychosocial losses in the lives of individuals. The project will proceed through three objectives: researching the components that affect the fracture, developing an intervention and implementing it. According to the first aim, it has been seen in the current literature that the most effective method in preventing the risk of fracture is to increase the medication adherence (MA) of the patients. It is seen that the Self-Regulatory Model (SRM)-based studies, in which the components explaining the MA of OP patients are examined as a model, constitute one of the limited theory-based studies. However, the SRM, which stands out as an effective model in explaining MA with its components of "perception of illness" and "beliefs about the medicine", is thought to base the medication use experience only on individual validities. Hence, the concept of MA is also provided by the patient-doctor relationship. Therefore, the effect of patient satisfaction on MA will be discussed in the components of SRM. There are also psychosocial factors that are thought to affect the possible fracture apart from all these diseases and treatment-related components. There are findings that the fear of falling, anxiety and social withdrawal caused by OP increase the risk of a possible fracture. Accordingly, patients' psychological challenges may affect protective behaviours such as exercise and a calcium-rich diet, and smoking. Therefore, it is predicted that the psychological symptom levels of the patients will affect the fracture through health behaviours. Besides, OP can bring along stress just like other chronic diseases, and perhaps even more social support needs can be seen in these patient groups with other chronic diseases. Hence, the moderator effect of social support between the psychological symptom level of OP patients and their stress' constitutes another sub-research question of this study. It is aimed to develop a comprehensive multidisciplinary and evidence-based intervention that prevents possible fracture experiences in OP patients.

Enrollment: 585 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary or secondary osteoporosis or osteopenia with a previous fragility fracture
• Taking osteoporosis medicines for at least 6 months
• Volunteer to attend to study

Exclusion criteria

• Having been diagnosed with osteoporosis for less than six months
• Not willing to fulfil the requirements of the study
• Having a neurological (such as dementia) or psychological (such as psychosis) condition that prevents completing the scales and establishing a relationship with the tester.

Trial design

585 participants in 1 patient group

Osteoporosis patients

Description:

Participants will fill out the self-report scales.