Osteoporosis Patient Education in Denmark

Sponsor

University of Southern Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05401968

Collaborator

National Research Center for Bone Health (Other)

3,340

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Behavioral: Osteoporosis patient education	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3340 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Differences in quality of life between intervention and control group [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)]
Measured with the 12-item Short-Form Health Survey of the Medical Outcomes Study (SF-12)
Differences in quality of life between intervention and control group [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)]
Measured with the generic EuroQol five dimensions with five levels (EQ-5D-5L)
Differences in clinical diagnosis of fracture between intervention and control group [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)]
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 [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)]
Measured with questions from the European Health Interview Survey
Differences in self-efficacy between intervention and control group [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)]
Measured with the questionnaire Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G)
Differences in psychological well-being between intervention and control group [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)]
Measured with the questionnaire Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Differences in physical function between intervention and control group [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)]
Measured with questions from The Danish National Health Survey
Differences in balance between intervention and control group [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)]
Measured with self-constructed, validated questions regarding problems with balance and balance confidence
Differences in falls between intervention and control group [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)]
Measured with self-constructed, validated questions regarding number of falls and concerns about falling
Differences in pain management between intervention and control group [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)]
Measured with the Pain Self-Efficacy Questionnaire (PSEQ)
Differences in adherence by Medication Possession Ratio (MPR) between intervention and control group [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)]
Including adherence to alendronate and ibandronate attained from the Danish National Prescription Registry

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Southern Denmark
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Southern Denmark

ClinicalTrials.gov Identifier:

NCT05401968

Other Study ID Numbers:

19/33410

First Posted:

Jun 2, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Southern Denmark

Patient education

Additional relevant MeSH terms:

Osteoporosis

Study Results

No Results Posted as of Jun 2, 2022