Osteoporosis Patient Education in Denmark

NCT ID: NCT05401968

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Osteoporosis patients who have participated in patient education

Group Type EXPERIMENTAL

Osteoporosis patient education

Intervention Type BEHAVIORAL

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.

Control group

Osteoporosis patients who have not participated in patient education

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Research Center for Bone Health

NETWORK

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Holmberg

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Andersen

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Hitz

Role: PRINCIPAL_INVESTIGATOR

National Research Center for Bone Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institute of Public Health, University of Southern Denmark

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19/33410

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Osteoporosis and Colles Fracture
NCT00225004 TERMINATED