Clinical trial NCT06969313: Telemedicine Intention, Need, Expectations, and Perceived Challenges Among Women With Osteoporosis
Official title: Telemedicine Intention, Need, Expectations, and Perceived Challenges Among Women With Osteoporosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Telemedicine
Keywords: telemedicine
telehealth
patient needs
osteoporosis
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-13
Enrollment: 197
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include postmenopausal women aged 50 to 85 years with a confirmed diagnosis of osteoporosis. Participants will be recruited from patients attending the Physical Medicine and Rehabilitation Department of Antalya City Hospital and the Gynecology Department of Antalya Anadolu Hospital. To reduce selection bias, a systematic sampling method was employed, whereby every third consecutive woman with osteoporosis who presented to the outpatient clinics during the data collection period was invited to participate in the study.

Brief summary: This study aims to explore the needs and expectations of women with postmenopausal osteoporosis regarding telemedicine services. Osteoporosis is a common condition among postmenopausal women that increases the risk of fractures and significantly affects quality of life. Many patients do not receive enough information about their disease and treatments during routine clinic visits, which may affect their ability to manage osteoporosis effectively. Participants will be divided into two age groups: those younger than 65 and those aged 65 or older. These subgroups will be compared in terms of their willingness to use telemedicine, their perceived need for such services, their expectations, preferred service topics, and anticipated barriers.

Telemedicine-including video consultations, remote monitoring, and online health education-can offer support to patients, especially for those facing difficulties in accessing healthcare, such as elderly individuals, those living in rural areas, or people with mobility issues.

In this research, women aged 50 to 85 who have been diagnosed with postmenopausal osteoporosis will be asked to complete a survey. The survey includes questions about their needs for telemedicine services, including which types of services (such as medication counseling, exercise programs, dietary advice, psychological support) would be most helpful for them.

The study will also examine if age, education level, past fractures, or family history of osteoporosis influence patients' preferences for telemedicine. By identifying these needs, this research aims to improve access to healthcare and develop personalized telemedicine services for women with osteoporosis in Turkey.

This is a non-interventional, observational, and anonymous survey-based study that will take approximately 10-15 minutes to complete. No medications, treatments, or physical tests will be applied.

Detailed description: This observational, cross-sectional study investigates the actual needs, preferences, and expectations of postmenopausal women with osteoporosis regarding the use of telemedicine services. Osteoporosis is a chronic, progressive condition characterized by decreased bone density and increased fracture risk, which can significantly impair mobility, and overall quality of life. Access to ongoing medical support is crucial for these patients, yet many-particularly older individuals-encounter substantial barriers such as physical limitations, transportation difficulties, limited caregiver availability, or lack of local specialist services.

Telemedicine has gained prominence as a solution to these challenges, offering remote access to healthcare services through technologies like video consultations, telephone check-ins, and online education tools. While telemedicine has been widely implemented during the COVID-19 pandemic, there remains a lack of data on how women with postmenopausal osteoporosis view these services, what features they find most useful, and what obstacles they anticipate.

The primary objective of this study is to evaluate which types of telemedicine services are most needed and preferred by this patient population-for example, support related to medication use, exercise programs, and dietary advice. The study also aims to determine whether specific sociodemographic and clinical variables-such as age, education level, marital status-are associated with participants' willingness to use telemedicine and their actual need for it.

To examine age-related differences, participants will be divided into two subgroups: those under 65 years of age and those aged 65 or older. These subgroups will be compared across multiple domains, including their interest in using telemedicine, actual necessity for such services (calculated according to parameters living alone, not driving/owning a car, having a chronic disease other than osteoporosis), expectations for care delivery, preferred content areas, and potential barriers (such as lack of internet access or digital literacy).

Data will be collected using a structured, self-administered questionnaire developed through expert consultation and adapted from validated tools in previous telehealth research. The questionnaire includes closed-ended questions and will be distributed during routine outpatient visits at two regional hospitals. Participants will be informed about the purpose of the study and assured of full anonymity and confidentiality. Completing the questionnaire is voluntary and is estimated to take approximately 10-15 minutes.

By identifying telemedicine-related needs specific to postmenopausal women with osteoporosis, this study seeks to support the creation of age-appropriate, patient-centered telehealth models. These findings may also inform healthcare providers and policymakers on how to design and implement accessible, effective, and equitable digital healthcare interventions to improve long-term disease management and patient outcomes in this growing patient population.

Eligibility criteria: Inclusion Criteria:

Female patients aged 50 to 85 years. Diagnosed with osteoporosis (based on clinical evaluation and prior diagnosis). Able to understand and complete the study questionnaire (adequate cognitive function).

Willing and able to provide informed consent and voluntarily participate in the study.

Exclusion Criteria:

Presence of severe medical conditions that may interfere with participation, including:

Severe cardiac diseases (e.g., advanced heart failure). Severe pulmonary diseases (e.g., advanced chronic obstructive pulmonary disease).

Advanced-stage cancer or other life-limiting illnesses. Cognitive impairment preventing understanding or completion of the questionnaire.

Participation in another clinical or interventional study at the same time. Recent significant trauma (physical or psychological) that may interfere with study participation.

Individuals who cannot understand the study goals and risks, or who refuse informed consent.

Primary outcomes:
measure: Intention to Use Telemedicine Services
timeFrame: Day 1
measure: Telemedicine Needs Index
timeFrame: Day 1
measure: Differences of telemedicine willingness and need between age groups
timeFrame: Day 1
Secondary outcomes:
measure: Patient-reported barriers to telemedicine use
timeFrame: Day 1
measure: Preferred topics for telemedicine services
timeFrame: Day 1
measure: Perceived impact of telemedicine on Quality of Life
timeFrame: Day 1
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya City Hospital
city: Antalya
country: Turkey
facility: Antalya Anatolia Hospital
Study officials:
affiliation: Antalya City Hospital
name: Selkin Yilmaz Muluk, MD
role: STUDY_CHAIR
References:
citation: Sasaki R, Yunoki T, Nakano Y, Fukui Y, Takemoto M, Morihara R, Abe K, Yamashita T. Actual Telemedicine Needs of Japanese Patients with Neurological Disorders in the COVID-19 Pandemic. Intern Med. 2023 Feb 1;62(3):365-371. doi: 10.2169/internalmedicine.9702-22. Epub 2022 Nov 23.
citation: Palacios S, Neyro JL, Fernandez de Cabo S, Chaves J, Rejas J. Impact of osteoporosis and bone fracture on health-related quality of life in postmenopausal women. Climacteric. 2014 Feb;17(1):60-70. doi: 10.3109/13697137.2013.808182. Epub 2013 Jul 30.
citation: Sood S, Mbarika V, Jugoo S, Dookhy R, Doarn CR, Prakash N, Merrell RC. What is telemedicine? A collection of 104 peer-reviewed perspectives and theoretical underpinnings. Telemed J E Health. 2007 Oct;13(5):573-90. doi: 10.1089/tmj.2006.0073.