Osteoporosis Patient Education in Denmark

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05401968
• Other study ID #: 19/33410
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: November 2023

Study information

• Verified date: October 2022
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3340
• Est. completion date: November 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.

Locations

Country	Name	City	State
Denmark	National Institute of Public Health, University of Southern Denmark	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	National Research Center for Bone Health

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)