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

NCT06603545 | Not Yet Recruiting

• 1 other identifier: DEOP001
• Study Type: interventional
• Target: 2,640
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoporosis; Accidental Falls; Fractures, Bone; Patient Reported Outcome Measures; Drug Adherence; Injury Traumatic

Outcome Measures

Primary Outcomes (1)

• Time to first event of clinical fracture.

  Time to first event of clinical fracture.

  Maximum follow-up four years.

Secondary Outcomes (6)

• Time to event death.

  Maximum follow-up four years.

• 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.

  At years 1 and 3.

• Change in physical activity level 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.

  From randomization to years 1 and 3.

Study Arms (2)

Digital education for osteoporosis patients (DEOP)

EXPERIMENTAL

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

No Digital education for osteoporosis patients (DEOP)

NO INTERVENTION

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.

Interventions

Digital education for osteoporosis patients OTHER

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.

Also known as: DEOP

Digital education for osteoporosis patients (DEOP)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with previous osteoporosis medication the last year.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Uppsala University Hospital: collaborator
• Region Stockholm: collaborator
• Västernorrland County Council, Sweden: collaborator
• Region Västerbotten: collaborator
• Region Skane: collaborator
• Norrbottens Lans Landsting: collaborator

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone; Medication Adherence; Wounds and Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Mattias Lorentzon, MD, PhD

  Sahlgrenska University Hospital, Västra Götalandsregionen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Brättemark, MSc

CONTACT

0046313431979; osteoporosforskning.su.molndal@vgregion.se

Mattias Lorentzon, MD, PhD

CONTACT

0046313431979; mattias.lorentzon@medic.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Consultant in Geriatric Medicine

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share