An Assessment of Treatment Adherence of Osteoporosis Patients From a Biopsychosocial Perspective

NCT05943600 | Not Yet Recruiting

• 1 other identifier: OPKO-1
• Study Type: observational
• Target: 585
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporosis; Osteoporotic Fractures; Psychosocial Functioning; Medication Adherence

Keywords

osteoporosis; fragile fracture risk; medication adherence; psychological symptom level; biopsychosocial model

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  through study completion; approximately 9 months

Secondary Outcomes (6)

• Brief Illness Perception Scale

  through study completion; approximately 9 months

• 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

• Perceived Stress Scale

  through study completion; approximately 9 months

• Multidimensional Perceived Social Support Scale

  through study completion; approximately 9 months

Other Outcomes (1)

• Sociodemographic and Clinical Information Form,

  through study completion; approximately 9 months

Study Arms (1)

Osteoporosis patients

Participants will fill out the self-report scales.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Osteoporosis patients take for at 6 months.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, 34, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 26832430 BACKGROUND

• 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.

  PMID: 23615816 BACKGROUND

Related Links

• Medication adherence project final report

MeSH Terms

Conditions

Osteoporosis; Osteoporotic Fractures; Medication Adherence

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Esin Temeloglu Sen, PhD

CONTACT

+905425726477; esin.sen@istanbul.edu.tr

Merih Akpinar, MD

CONTACT

905333558843; merihcaliskan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Dr. (PhD)

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 13, 2023
• Study Start: July 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: April 15, 2026
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)