Clinical trial NCT05943600: An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective
Official title: An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective to Plan a Multidisciplinary Intervention Overcame Psychosocial Barriers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoporosis
Osteoporotic Fractures
Psychosocial Functioning
Medication Adherence
Keywords: osteoporosis
fragile fracture risk
medication adherence
psychological symptom level
biopsychosocial model
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-07-13
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Osteoporosis patients take for at 6 months.

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medication Adherence Report Scale
timeFrame: through study completion; approximately 9 months
measure: Fragility Fracture Information Form
timeFrame: through study completion; approximately 9 months
measure: Health Behavior Assessment Form
timeFrame: through study completion; approximately 9 months
Secondary outcomes:
measure: Brief Illness Perception Scale
timeFrame: through study completion; approximately 9 months
measure: The Beliefs About the Medicines Scale-Specific
timeFrame: through study completion; approximately 9 months
measure: The Short Assessment of Patient Satisfaction
timeFrame: through study completion; approximately 9 months
measure: Perceived Stress Scale
timeFrame: through study completion; approximately 9 months
measure: Multidimensional Perceived Social Support Scale
timeFrame: through study completion; approximately 9 months
measure: Brief Symptom Inventory- Depression and Anxiety
timeFrame: through study completion; approximately 9 months
Other outcomes:
measure: Sociodemographic and Clinical Information Form,
timeFrame: through study completion; approximately 9 months
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
Study officials:
References:
citation: Clyne W, Mshelia C, McLachlan S, Jones P, de Geest S, Ruppar T, Siebens K, Dobbels F, Kardas P. A multinational cross-sectional survey of the management of patient medication adherence by European healthcare professionals. BMJ Open. 2016 Feb 1;6(2):e009610. doi: 10.1136/bmjopen-2015-009610.
citation: Chandran M, Tan MZ, Cheen M, Tan SB, Leong M, Lau TC. Secondary prevention of osteoporotic fractures--an "OPTIMAL" model of care from Singapore. Osteoporos Int. 2013 Nov;24(11):2809-17. doi: 10.1007/s00198-013-2368-8. Epub 2013 Apr 25.