OsteoporosisNCT05943600
An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective
An observational study of Osteoporosis and Osteoporotic Fractures, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Osteoporotic Fractures, Psychosocial Functioning
- How many people
- 585 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 15 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Osteoporosis patients take for at 6 months.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul, 34
Merih Akpinar, MD, 905333558843, merihcaliskan@gmail.com
About this study
Official title: An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective to Plan a Multidisciplinary Intervention Overcame Psychosocial Barriers
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
Read the 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.
- Keywords
- osteoporosis, fragile fracture risk, medication adherence, psychological symptom level, biopsychosocial model
- Medical subject headings
- Osteoporosis, Osteoporotic Fractures, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Osteoporosis patients | Participants will fill out the self-report scales. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Report Scale
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.
Measured: through study completion; approximately 9 months
Fragility Fracture Information Form
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.
Measured: through study completion; approximately 9 months
Health Behavior Assessment Form
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.
Measured: through study completion; approximately 9 months
Secondary outcomes (6)
Brief Illness Perception Scale
The scale will be used to assess participants' illness perception and cognition. To score the Brief Illness Perception Scale questionnaire, each item is rated on a 0-10 scale, with higher scores indicating a more threatening perception of the illness. The total score is calculated by summing the scores of all seven items, with a possible range of 0-70. Higher scores indicate worse illness perception.
Measured: through study completion; approximately 9 months
The Beliefs About the Medicines Scale-Specific
The scale will be used to assess the appraisal of the medicines. The Beliefs About the Medicines Scale-Specific consists of two five-item scales assessing participants' beliefs about the necessity of prescribed medication for controlling their disease and their concerns about potential adverse consequences of taking it. Respondents indicate their degree of agreement with each statement on a five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items within both scales are summed. A mean score for each scale is computed by dividing total scores for that scale by the number of items in the scale, resulting in a mean score range of 1-5 for each scale. Higher scores indicate stronger beliefs in the concepts represented by the scale.
Measured: through study completion; approximately 9 months
The Short Assessment of Patient Satisfaction
The scale will be used to assess patient satisfaction comprised of a short seven-item scale that has 5-point responses, scored as 0 to 4. The scale assesses the core domains of patient satisfaction which includes treatment satisfaction, explanation of treatment results, clinician care, participation in medical decision-making, respect by the clinician, time with the clinician, and satisfaction with clinic care. The score ranges from 0 (extremely dissatisfied) to 28 (extremely satisfied), as a continuous score. Additionally, categorical scores are defined as 0-10 very dissatisfied, 11-18 dissatisfied, 19-26 satisfied, and 27-28 very satisfied.
Measured: through study completion; approximately 9 months
Perceived Stress Scale
The scale will be used to assess the stress perception of participants. The scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress, and scores ranging from 27-40 would be considered high perceived stress.
Measured: through study completion; approximately 9 months
Multidimensional Perceived Social Support Scale
The scale will be used to assess the social support level of participants. The scale is a short instrument designed to measure an individual's perception of support from 3 sources: family, friends and a significant other. To calculate the total score, all 12 items are summed. This total score can also be calculated as a mean score (dividing by 12). A mean scale score ranging from 1 to 2.9 could be considered low support; a score of 3 to 5 could be considered moderate support; a score from 5.1 to 7 could be considered high support.
Measured: through study completion; approximately 9 months
Brief Symptom Inventory- Depression and Anxiety
The scale is a 13-item self-report scale designed to evaluate the depression and anxiety symptoms levels of participants. This scale uses a 5-point Likert scale, ranging from 0 ("not at all") to 4 ("extremely"). Brief Symptom Inventory- Depression and Anxiety scores can range from 0 to 52 points with higher scores indicating higher suffering from depression and anxiety symptoms.
Measured: through study completion; approximately 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 585 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Esin Temeloglu Sen, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943600
- Sponsor's protocol ID
- OPKO-1
- Status last verified
- Jul 2023
- First submitted
- 13 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share any individual participant data with other researchers.
Publications
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.
PubMed 26832430Chandran 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.
PubMed 23615816
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective to Plan a Multidisciplinary Intervention Overcame Psychosocial Barriers
- ClinicalTrials.gov ID
- NCT05943600
- Acronym / sponsor ID
- OPKO-1
- Keywords
- osteoporosis, fragile fracture risk, medication adherence, psychological symptom level, biopsychosocial model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 585 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoporosis patients | – | –Participants will fill out the self-report scales. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Osteoporosis patients take for at 6 months.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication Adherence Report Scale
Time frame: 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
Time frame: 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.
Health Behavior Assessment Form
Time frame: 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.
6 secondary outcomes
Brief Illness Perception Scale
Time frame: through study completion; approximately 9 months
The Beliefs About the Medicines Scale-Specific
Time frame: through study completion; approximately 9 months
The Short Assessment of Patient Satisfaction
Time frame: through study completion; approximately 9 months
Perceived Stress Scale
Time frame: through study completion; approximately 9 months
Multidimensional Perceived Social Support Scale
Time frame: through study completion; approximately 9 months
Brief Symptom Inventory- Depression and Anxiety
Time frame: through study completion; approximately 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 26832430Clyne 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.
- Background: PubMed 23615816Chandran 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.
- Medication adherence project final reportLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will not share any individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Osteoporotic Fractures, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esin Temeloglu Sen, PhD (+905425726477, esin.sen@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Report Scale (time frame: through study completion; approximately 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05943600, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.