Osteoporosis Patient Education in Denmark

Osteoporosis Patient Education in Danish Municipalities: an Evaluation of Existing Programs and Recommendations for Further Practice

In an effect evaluation the investigators will examine the effects of participating in osteoporosis patient education. An intervention group who have already participated in patient education will be compared to a matched control group who have not participated. Effects on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence will be examined.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Behavioral: Osteoporosis patient education

Detailed Description

In this quasi-experimental study the investigators will conduct an effect evaluation that compares an intervention group of osteoporosis patients who have participated in patient education in a municipality with a control group who have not participated.

The intervention group consists of citizens who have already participated in osteoporosis patient education from 2016 until 2020. The investigators have received information on the intervention group from the municipalities who store data on previous participants.

The control group will be extracted via the Danish Health Data Authority and consists of citizens who have not participated in osteoporosis patient education. For each individual in the intervention group one control will be matched regarding gender, age, diagnosis, time of diagnose, and type of fracture before the index date (i.e. the date the individual in the intervention group started on patient education).

The aim of the effect evaluation is to examine the effects of osteoporosis patient education on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence.

Data is generated from a register extraction and a questionnaire-based survey. The questionnaire will include information on quality of life, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, and pain management. As far as possible validated questionnaires will be included to measure these outcomes. The register extraction will be made by the Danish Health Data Authority and include information on fractures and adherence.

All analyses are performed using Stata. In the analyses the investigators will compare the intervention group and the control group with regard to all outcomes. The covariates are selected on the basis of Directed Acyclic Graphs (DAG) and they include e.g. socioeconomic status, cohabitee status, and co-morbidity. The analysis will be completed on an intention to treat basis.

• Study Type: Interventional
• Enrollment (Actual): 3132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • National Institute of Public Health, University of Southern Denmark

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• To participate in osteoporosis patient education in municipalities the participants should have osteoporosis or in few cases osteopenia.

Exclusion Criteria:

• None though this may vary across municipalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Osteoporosis patients who have participated in patient education	Behavioral: Osteoporosis patient education; During osteoporosis patient education the participants get knowledge about e.g. osteoporosis, medication, and diet, and they participate in physical exercises. Though, differences between municipalities exist. The participants meet in groups and face-to-face.
No Intervention: Control group; Osteoporosis patients who have not participated in patient education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in quality of life between intervention and control group	Measured with the 12-item Short-Form Health Survey of the Medical Outcomes Study (SF-12)	At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in clinical diagnosis of fracture between intervention and control group	Including hip, vertebral, forearm, and upper arm fractures registered in the National Patient Register	At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in daily functional capacity between intervention and control group	Measured with questions from the European Health Interview Survey	At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in self-efficacy between intervention and control group	Measured with the questionnaire Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G)	At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in psychological well-being between intervention and control group	Measured with the questionnaire Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)	At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in physical function between intervention and control group	Measured with questions from The Danish National Health Survey	At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in balance between intervention and control group	Measured with self-constructed, validated questions regarding problems with balance and balance confidence	At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in falls between intervention and control group	Measured with self-constructed, validated questions regarding number of falls and concerns about falling	At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in pain management between intervention and control group	Measured with the Pain Self-Efficacy Questionnaire (PSEQ)	At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in adherence by Medication Possession Ratio (MPR) between intervention and control group	Including adherence to alendronate and ibandronate attained from the Danish National Prescription Registry	At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: National Research Center for Bone Health
• Investigators: Principal Investigator: Holmberg, University of Southern Denmark; Principal Investigator: Andersen, University of Southern Denmark; Principal Investigator: Hitz, National Research Center for Bone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Patient education
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Osteoporosis
• Other Study ID Numbers: 19/33410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If possible, we will store data at The Danish National Archives. We will apply for storing at a later date.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No