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临床试验/NCT05943600
NCT05943600尚未招募不适用

An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective to Plan a Multidisciplinary Intervention Overcame Psychosocial Barriers

Istanbul University1 个研究点 分布在 1 个国家目标入组 585 人开始时间: 2023年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
585
试验地点
1
主要终点
Health Behavior Assessment Form

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Health Behavior Assessment Form

时间窗: through study completion; approximately 9 months

The form will be used to assess the smoking, diet or alcohol consumption of participants. There are no cut-off values since this form will give the investigators descriptive information.

Medication Adherence Report Scale

时间窗: through study completion; approximately 9 months

This scale will be used to assess the medication adherence level of patients. The scale is scored between 5 to 25 points with lower scores indicating higher adherence level.

Fragility Fracture Information Form

时间窗: through study completion; approximately 9 months

The form will be used to assess the fragility fracture experience of participants. There are no cut-off values since this form will give the investigators descriptive information.

次要结局

  • The Beliefs About the Medicines Scale-Specific(through study completion; approximately 9 months)
  • The Short Assessment of Patient Satisfaction(through study completion; approximately 9 months)
  • Brief Illness Perception Scale(through study completion; approximately 9 months)
  • Multidimensional Perceived Social Support Scale(through study completion; approximately 9 months)
  • Brief Symptom Inventory- Depression and Anxiety(through study completion; approximately 9 months)
  • Perceived Stress Scale(through study completion; approximately 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esin Temeloglu Sen

Research Assistant Dr. (PhD)

Istanbul University

研究点 (1)

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