A digital education for osteoporosis patients (DEOP) has been developed and tested on patients in Region Vastra Gotaland, Sweden. Currently, the evidence regarding the efficacy of patient education on fracture risk, medication adherence, injurious falls, levels of physical activity, and diet is insufficient. Most patients with osteoporosis in Sweden are diagnosed and treated in primary care, where the knowledge about osteoporosis is often very limited. Thus, in general, osteoporosis patients are not sufficiently informed before receiving a treatment recommendation. This randomized controlled trial aims to investigate if DEOP vs. standard care can reduce the incidence of fracture in older women and men, and if the intervention leads to better adherence to osteoporosis medication, higher quality of life, increased physical activity, and enhanced diet.
The primary objective is to investigate if DEOP compared to standard care (without DEOP), can reduce the incidence of clinical fractures in men and women, over the age of 65 years, without previous osteoporosis medication the last year, who have been recommended osteoporosis treatment after a DXA scan and assessment of clinical risk factors at an osteoporosis clinic.
The secondary objectives are to investigate if DEOP compared to standard care (without DEOP), can reduce the incidence of injurious falls, have positive effects on adherence to osteoporosis medication, positively affect diet (calcium and vitamin D intake), physical activity, and improve quality of life in men and women, over the age of 65 years, without previous osteoporosis medication the last year, who have been recommended osteoporosis treatment after a DXA scan and assessment of clinical risk factors at an osteoporosis clinic.
Study design: randomized multicentre clinical trial. Patients over the age of 65 visiting an osteoporosis unit for a bone density scan (DXA) will be asked to participate in the study. The participants will be randomized to one of two arms where one arm will be invited to DEOP and the other arm will receive standard care, without DEOP.
Patients visiting an osteoporosis unit, 65 years and older.
Ability to understand and follow study instructions.
Signed informed consent.
Have been recommended pharmacological osteoporosis treatment after a clinical evaluation including a DXA-scan and assessment of fracture risk at an osteoporosis clinic.
Patients with previous osteoporosis medication the last year.
Parallel
Digital education for osteoporosis patients
Other interventionDEOP is found on the Swedish health care system's dedicated website or app 1177, it takes approximately 60 minutes to complete and is composed of three modules: 1)Introduction: an animated video that shows the patient flow from having a fracture, being evaluated at the osteoporosis clinic, receiving information about osteoporosis, and being treated for osteoporosis. 2)Osteoporosis: basic information about osteoporosis; why it occurs, risk factors that the patient can affect (such as physical inactivity and smoking), and risk factors that cannot be affected (such as age and heredity). It provides information about typical osteoporotic fractures, and how a patient is evaluated according to clinical guidelines for osteoporosis care. 3)Treatment: information about the different kinds of pharmacological osteoporosis treatment, physical activity, balance control, lifting technique, risk of falling, and dietary advice, especially regarding calcium and vitamin D intake.
Time to first event of clinical fracture.
Time to first event of clinical fracture.
Time to event death.
Time to event death.
Time to first event of an injurious fall
Time to first event of an injurious fall
Adherence (percent remaining on treatment) to osteoporosis drug therapy at years 1 and 3.
Adherence (percent remaining on treatment) to osteoporosis drug therapy at years 1 and 3.
Change in physical activity level from randomization to years 1 and 3.
Change in physical activity level, measured in the Physical Activity Scale of the Elderly (PASE; 0-793) from randomization to years 1 and 3.
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Sahlgrenska University Hospital
Lead sponsor
Uppsala University Hospital
Collaborator
Region Stockholm
Collaborator
Västernorrland County Council, Sweden
Collaborator
Region Västerbotten
Collaborator
Region Skane
Collaborator
Norrbottens Lans Landsting
Collaborator
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