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Osteoporosis Patient Education in Denmark

Primary Purpose

Osteoporosis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Osteoporosis patient education
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Patient education

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Public Health, University of Southern Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Osteoporosis patients who have participated in patient education

Osteoporosis patients who have not participated in patient education

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Differences in daily functional capacity between intervention and control group
Measured with questions from the European Health Interview Survey
Differences in self-efficacy between intervention and control group
Measured with the questionnaire Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G)
Differences in psychological well-being between intervention and control group
Measured with the questionnaire Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Differences in physical function between intervention and control group
Measured with questions from The Danish National Health Survey
Differences in balance between intervention and control group
Measured with self-constructed, validated questions regarding problems with balance and balance confidence
Differences in falls between intervention and control group
Measured with self-constructed, validated questions regarding number of falls and concerns about falling
Differences in pain management between intervention and control group
Measured with the Pain Self-Efficacy Questionnaire (PSEQ)
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

Full Information

First Posted
May 23, 2022
Last Updated
October 4, 2022
Sponsor
University of Southern Denmark
Collaborators
National Research Center for Bone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05401968
Brief Title
Osteoporosis Patient Education in Denmark
Official Title
Osteoporosis Patient Education in Danish Municipalities: an Evaluation of Existing Programs and Recommendations for Further Practice
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark
Collaborators
National Research Center for Bone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Patient education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The municipalities recruit and include citizens in osteoporosis patient education. We have already received information on participants from 2016 until 2020, and thereafter we will create a matched control group, who have not participated in osteoporosis patient education.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Osteoporosis patients who have participated in patient education
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Osteoporosis patients who have not participated in patient education
Intervention Type
Behavioral
Intervention Name(s)
Osteoporosis patient education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences in quality of life between intervention and control group
Description
Measured with the 12-item Short-Form Health Survey of the Medical Outcomes Study (SF-12)
Time Frame
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)
Title
Differences in clinical diagnosis of fracture between intervention and control group
Description
Including hip, vertebral, forearm, and upper arm fractures registered in the National Patient Register
Time Frame
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 Measure Information:
Title
Differences in daily functional capacity between intervention and control group
Description
Measured with questions from the European Health Interview Survey
Time Frame
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)
Title
Differences in self-efficacy between intervention and control group
Description
Measured with the questionnaire Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G)
Time Frame
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)
Title
Differences in psychological well-being between intervention and control group
Description
Measured with the questionnaire Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time Frame
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)
Title
Differences in physical function between intervention and control group
Description
Measured with questions from The Danish National Health Survey
Time Frame
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)
Title
Differences in balance between intervention and control group
Description
Measured with self-constructed, validated questions regarding problems with balance and balance confidence
Time Frame
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)
Title
Differences in falls between intervention and control group
Description
Measured with self-constructed, validated questions regarding number of falls and concerns about falling
Time Frame
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)
Title
Differences in pain management between intervention and control group
Description
Measured with the Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame
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)
Title
Differences in adherence by Medication Possession Ratio (MPR) between intervention and control group
Description
Including adherence to alendronate and ibandronate attained from the Danish National Prescription Registry
Time Frame
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)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holmberg
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andersen
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hitz
Organizational Affiliation
National Research Center for Bone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Public Health, University of Southern Denmark
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If possible, we will store data at The Danish National Archives. We will apply for storing at a later date.

Learn more about this trial

Osteoporosis Patient Education in Denmark

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