The Effect of Digital Education for Osteoporosis Patients on Fracture Risk and Related Health Outcomes.

The Effect of Digital Education for Osteoporosis Patients on Fracture Risk and Related Health Outcomes in Older Swedish Men and Women.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fractures, Bone; Osteoporosis; Patient Reported Outcome Measures; Accidental Falls; Drug Adherence; Injury Traumatic
• Intervention / Treatment: Other: Digital education for osteoporosis patients

Detailed Description

The hypothesis is that improved patient education using an easily accessible online educational material will result in better adherence to osteoporosis medication and positive lifestyle changes, which will lead to a lower risk of fractures and injurious falls. The primary aim of this study is to investigate if a Digital Education for Osteoporosis Patients (DEOP) affects the risk of sustaining a clinical fracture in patients over the age of 65 who have been recommended osteoporosis treatment after a bone density (DXA) scan. The secondary aims are to investigate if DEOP affects the risk of injurious falls, adherence to osteoporosis medications, improves dietary intake and quality of life, and increases physical activity compared to standard care.

The planned study is a multicentre randomized controlled trial, with 9 participating study centers (osteoporosis clinics). Patients who have not previously received osteoporosis medication the last year and are over the age of 65 visiting an osteoporosis clinic for a clinical evaluation, including a bone density scan (DXA) and assessment of clinical risk factors and fracture risk, will be asked to participate in the study. Before the appointment for the DXA measurement, possible study participants will receive written information about the study by mail. At the visit, oral information about the study will be provided by the bone densitometry technologist. Written information will be distributed to possible participants that have not previously received the information. The patients must have the opportunity to ask questions before they make their decision to participate or not. Acceptance to participate must be communicated both verbally and through signing an informed consent form. All patients will undergo a DXA-scan and answer a questionnaire regarding clinical risk factors included in the fracture risk assessment tool FRAX, according to local clinical guidelines.

At a later stage, if the patient, by the doctor at the osteoporosis clinic, is recommended pharmacological treatment for osteoporosis (due to a high fracture risk), the patient becomes eligible for the study. If the patient does not have an indication to receive osteoporosis medication, as judged by the physician at the osteoporosis unit, the patient will be excluded from the study as screening failure and receive a notification of this through e-mail or regular mail.

Patients eligible for the study will be randomized, stratified according to sex and study center, into one of two arms where patients in one arm will be invited to the DEOP and patients in the other arm will receive standard care, without the DEOP. Patients in both groups will be treated and followed according to clinical guidelines for osteoporosis care in their health care region, by either a general practitioner (GP) or a doctor at an osteoporosis clinic. Only osteoporosis clinics without an ongoing DEOP will be eligible as study clinics in these health care regions. After randomization, the local study coordinator will contact all included patients through e-mail or regular mail and ask them to complete self-reported questionnaires regarding physical activity, diet, and quality of life (Physical Activity Scale for the Elderly (PASE), Food Frequency Questionnaire (FFQ), and quality of life (Short Form survey, SF-12), respectively). Data regarding clinical risk factors (and calculated 10-year probability of major osteoporotic fracture and hip fracture) in the fracture risk assessment tool FRAX, height, and weight, and bone mineral density (BMD; of the lumbar spine, total hip, and femoral neck, in grams/cm2 and as T-scores) will be collected from the osteoporosis clinic by the local study coordinator or other study personnel. After years 1 and 3, an e-mail or regular mail (if the study participant does not use e-mail) will be sent to the participants and they will be asked to answer the same questionnaires again. Data regarding clinical fractures will be collected from the Patient Register (Socialstyrelsen, the National Board of Health and Welfare), the Swedish Fracture Register, and from regional X-ray archives after the end of the study (maximum 4 years of follow-up). Data on the incidence of injurious falls (including injuries without fracture) will be collected through the Patient Register at the end of the study. Data on osteoporosis medication use will be collected from the Drug Dispensation Register and regional databases regarding medications provided at health care facilities at the end of the study. Data on deaths will be collected using the National Cause of Death Register. Data on diagnoses and medication will be collected five years back from the inclusion date to determine comorbidity.

The participants in the DEOP group will be given access to the DEOP for four months after randomization. Reminders will be sent out using phone text messages monthly for the first 3 months to participants who have not yet started the DEOP. The control group will be given information regarding fall prevention, physical activity, diet, and osteoporosis medication according to standard care, by their GP or the physician at the osteoporosis clinics, depending on where they are treated for their osteoporosis.

• Study Type: Interventional
• Enrollment (Estimated): 2640
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Brättemark, MSc; Phone Number: 0046313431979; Email: osteoporosforskning.su.molndal@vgregion.se
• Study Contact Backup: Name: Mattias Lorentzon, MD, PhD; Phone Number: 0046313431979; Email: mattias.lorentzon@medic.gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Have access to www.1177.se.

Exclusion Criteria:

• Patients with previous osteoporosis medication the last year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital education for osteoporosis patients (DEOP); The participants in the DEOP group will be given access to the DEOP for four months after randomization, and can redo the education multiple times within those four months. Reminders will be sent out using phone text messages monthly for the first 3 months to participants who have not yet started the DEOP. The experimental group will also be given information, according to standard care, regarding fall prevention, physical activity, diet, and osteoporosis medication according to standard care, by their GP or the physician at the osteoporosis clinics, depending on where they are treated for their osteoporosis.	Other: Digital education for osteoporosis patients; DEOP 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.; Other Names: DEOP
No Intervention: No Digital education for osteoporosis patients (DEOP); The control group will be given information regarding fall prevention, physical activity, diet, and osteoporosis medication according to standard care, by their GP or the physician at the osteoporosis clinics, depending on where they are treated for their osteoporosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first event of clinical fracture.	Time to first event of clinical fracture.	Maximum follow-up four years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to event death.	Time to event death.	Maximum follow-up four years.
Time to first event of an injurious fall	Time to first event of an injurious fall	Maximum follow-up four years.
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.	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.	From randomization to years 1 and 3.
Change in dietary intake (total daily intake of calcium and vitamin D) from randomization to years 1 and 3.	Change in dietary intake (total daily intake of calcium (mg/day) and vitamin D (IU/day)) from randomization to years 1 and 3.	From randomization to years 1 and 3.
Change in quality of life from randomization to years 1 and 3.	Change in quality of life (measured using the SF-12 scale) from randomization to years 1 and 3.	From randomization to years 1 and 3.

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Region Skane; Region Stockholm; Region Västerbotten; Uppsala University Hospital; Västernorrland County Council, Sweden; Norrbottens Lans Landsting
• Investigators: Principal Investigator: Mattias Lorentzon, MD, PhD, Sahlgrenska University Hospital, Västra Götalandsregionen

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Wounds and Injuries; Fractures, Bone; Osteoporosis
• Other Study ID Numbers: DEOP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No