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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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
Condition or disease |
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Osteoporosis Osteoporotic Fractures Psychosocial Functioning Medication Adherence |
Study Type : | Observational |
Estimated Enrollment : | 585 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective to Plan a Multidisciplinary Intervention Overcame Psychosocial Barriers |
Estimated Study Start Date : | July 15, 2023 |
Estimated Primary Completion Date : | March 15, 2024 |
Estimated Study Completion Date : | April 15, 2026 |
Group/Cohort |
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Osteoporosis patients
Participants will fill out the self-report scales.
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- 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.
- Brief Illness Perception Scale [ Time Frame: through study completion; approximately 9 months ]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.
- The Beliefs About the Medicines Scale-Specific [ Time Frame: through study completion; approximately 9 months ]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.
- The Short Assessment of Patient Satisfaction [ Time Frame: through study completion; approximately 9 months ]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.
- Perceived Stress Scale [ Time Frame: through study completion; approximately 9 months ]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.
- Multidimensional Perceived Social Support Scale [ Time Frame: through study completion; approximately 9 months ]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.
- Brief Symptom Inventory- Depression and Anxiety [ Time Frame: through study completion; approximately 9 months ]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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05943600
Contact: Esin Temeloglu Sen, PhD | +905425726477 | esin.sen@istanbul.edu.tr | |
Contact: Merih Akpinar, MD | 905333558843 | merihcaliskan@gmail.com |
Turkey | |
Istanbul University, Istanbul Faculty of Medicine | |
Istanbul, Turkey, 34 | |
Contact: Merih Akpinar, MD 905333558843 merihcaliskan@gmail.com |
Publications:
Responsible Party: | Esin Temeloglu Sen, Research Assistant Dr. (PhD), Istanbul University |
ClinicalTrials.gov Identifier: | NCT05943600 |
Other Study ID Numbers: |
OPKO-1 |
First Posted: | July 13, 2023 Key Record Dates |
Last Update Posted: | July 13, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | We will not share any individual participant data with other researchers. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
osteoporosis fragile fracture risk medication adherence psychological symptom level biopsychosocial model |
Osteoporosis Osteoporotic Fractures Fractures, Bone Wounds and Injuries |
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |