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Osteoporosis Patient Education in Denmark

University of Southern Denmark (SDU) logo

University of Southern Denmark (SDU)

Status

Active, not recruiting

Conditions

Osteoporosis

Treatments

Behavioral: Osteoporosis patient education

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT05401968
19/33410

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,132 patients

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,132 participants in 2 patient groups

Intervention group
Experimental group
Description:
Osteoporosis patients who have participated in patient education
Treatment:
Behavioral: Osteoporosis patient education
Control group
No Intervention group
Description:
Osteoporosis patients who have not participated in patient education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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