An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective
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ClinicalTrials.gov Identifier: NCT05943600 |
Recruitment Status :
Not yet recruiting
First Posted : July 13, 2023
Last Update Posted : July 13, 2023
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Sponsor:
Istanbul University
Collaborator:
THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE (TUBITAK)
Information provided by (Responsible Party):
Esin Temeloglu Sen, Istanbul University
Tracking Information | |||||||||
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First Submitted Date | June 13, 2023 | ||||||||
First Posted Date | July 13, 2023 | ||||||||
Last Update Posted Date | July 13, 2023 | ||||||||
Estimated Study Start Date | July 15, 2023 | ||||||||
Estimated Primary Completion Date | March 15, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
Sociodemographic and Clinical Information Form, [ Time Frame: through study completion; approximately 9 months ] The form will be used to get an illness history and demographical information. There are no cut-off values since this form will give the investigators descriptive information.
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title | 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 | ||||||||
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:
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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. | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Osteoporosis patients take for at 6 months. | ||||||||
Condition |
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Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Osteoporosis patients
Participants will fill out the self-report scales.
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Not yet recruiting | ||||||||
Estimated Enrollment |
585 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | April 15, 2026 | ||||||||
Estimated Primary Completion Date | March 15, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Turkey | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT05943600 | ||||||||
Other Study ID Numbers | OPKO-1 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Esin Temeloglu Sen, Istanbul University | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor | Istanbul University | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators | THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE (TUBITAK) | ||||||||
Investigators | Not Provided | ||||||||
PRS Account | Istanbul University | ||||||||
Verification Date | July 2023 |