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NCT Number: NCT06462833

Health Literacy's Impact on Exercise Habits and Medication Adherence in Postmenopausal Osteoporosis

Postmenopausal osteoporosis is characterized by low bone mass and increased fracture risk. Treatment includes exercise, nutrition, supplements, and medications like bisphosphonates, denosumab, or hormone replacement therapy. Lifestyle changes such as quitting smoking, reducing alcohol consumption, and preventing falls are also crucial.

Despite effective treatments, adherence is low: 20-30% of patients don't start oral bisphosphonates, and 16-60% continue medications after one year. Exercise adherence rates are similarly low (14.3%-57.7%). This non-adherence imposes a significant clinical and economic burden.

Health literacy (HL)-the ability to find, understand, and use health information-is vital for managing health but is understudied in relation to osteoporosis treatment adherence. This study aims to examine the relationship between HL, exercise habits, and medication adherence in postmenopausal osteoporosis patients. Understanding these factors can lead to effective interventions, improving patient adherence and health outcomes.

The study will measure HL levels and their correlation with medication and exercise adherence, potentially informing health education programs and strategies to enhance treatment adherence. By doing so, it aims to improve health outcomes and healthcare system efficiency.

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Key information

Conditions

Osteoporosis, Postmenopausal Behavior Bone Diseases Bone Diseases, Metabolic Health Behavior Medication Adherence Metabolic Diseases Motor Activity Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

Postmenopausal osteoporosis is a common bone disease characterized by low bone mass, deterioration of bone tissue microarchitecture, and an increased risk of fractures. This condition results from the imbalance between bone formation and resorption due to decreased estrogen levels. Fractures, the feared complication of osteoporosis, make this condition a significant problem both clinically and from a public health perspective. In Europe, postmenopausal osteoporosis affects approximately 22 million women and causes over 3.5 million fragility fractures annually.

Treatment options include regular exercise, healthy nutrition, calcium and vitamin D supplementation, and pharmacological treatments such as bisphosphonates, denosumab, or hormone replacement therapy. Additionally, quitting smoking, reducing alcohol consumption, and preventing falls are crucial in preventing osteoporosis and osteoporotic fractures. Despite the availability of safe and effective medications to reduce fracture risk, many patients either do not start treatment or do not adhere to it adequately. This non-adherence to treatment results in a significant clinical and economic burden. Following the prescription of medications, a substantial percentage of patients, around 20-30%, do not start taking oral bisphosphonates, and the continuation rate of osteoporosis medications over one year is reported to range from 16% to 60%. Furthermore, low levels of adherence to resistance/weight-bearing exercises (36.3%-54.4%) and physical activity (14.3%-57.7%) have been observed.

Health literacy (HL) is defined as the capacity of individuals to find, understand, evaluate, and apply health-related information to prevent diseases, develop healthy eating behaviors, and improve their health. There are limited studies on the impact of health literacy on adherence to osteoporosis treatment in postmenopausal osteoporosis patients. However, no study has investigated the effect of HL on both medical treatment adherence and exercise adherence in postmenopausal osteoporosis patients.

This study aims to investigate the relationship between health literacy, exercise habits, and medication adherence in postmenopausal osteoporosis patients. By identifying the factors leading to non-adherence to osteoporosis-preventive medications and regular exercise, effective interventions to enhance adherence to these treatments can be determined. This can result in better health outcomes for patients and increased efficiency within the healthcare system.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal patients
  • Being under outpatient follow-up for osteoporosis for at least one year

Exclusion criteria

  • Orthopedic, rheumatic, and neurological conditions that may hinder participation in exercise
  • Cancer
  • Refusal to participate in the study

Treatment and study plan

Primary outcomes

  1. Health literacy

    Time frame: Patients will be evaluated once in the baseline.

    Health literacy is the capacity of individuals to find, understand, evaluate, and apply health-related information to prevent diseases, develop healthy eating behaviors, and improve their health.

    The Turkish Health Literacy Scale-32 (THLS-32) will be used to assess the health literacy levels of the patients. THLS-32 is a 32-item Likert-type scale. Scores on the scale range from 0 indicating the lowest health literacy to 50 indicating the highest health literacy.

Secondary outcomes

  1. Medication adherence

    Time frame: Patients will be evaluated once in the baseline.

    The Medication Adherence Report Scale (MARS) will be used to assess medication adherence in patients. This scale consists of five different statements involving negative medication adherence behaviors, including deciding to skip doses, forgetting to take medication, changing the dosage, temporarily stopping medication intake, and taking less than prescribed. The total score on the MARS ranges from 5 to 25 points, with higher scores indicating better medication adherence

  2. Physical activity

    Time frame: Patients will be evaluated once in the baseline.

    The International Physical Activity Questionnaire (IPAQ) was developed in 1998 for global physical activity surveillance. Since then, it has become the most widely used physical activity questionnaire. IPAQ-Short Form (IPAQ-SF) is a 7-item questionnaire that assesses the level of activity (low, moderate, high physical activity) in the past seven days.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayça Utkan Karasu, MD

CONTACT

[email protected]

+905365759757

Levent Karataş, MD

CONTACT

[email protected]

+905055629437

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

The Relationship Between Health Literacy, Exercise Habits, and Medication Adherence in Postmenopausal Osteoporosis Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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