Clinical trial NCT05401968: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoporosis
Keywords: Patient education
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: National Research Center for Bone Health
First posted: 2022-06-02
Enrollment: 3132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Differences in quality of life between intervention and control group
timeFrame: 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)
measure: Differences in clinical diagnosis of fracture between intervention and control group
timeFrame: 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 outcomes:
measure: Differences in daily functional capacity between intervention and control group
timeFrame: 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)
measure: Differences in self-efficacy between intervention and control group
timeFrame: 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)
measure: Differences in psychological well-being between intervention and control group
timeFrame: 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)
measure: Differences in physical function between intervention and control group
timeFrame: 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)
measure: Differences in balance between intervention and control group
timeFrame: 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)
measure: Differences in falls between intervention and control group
timeFrame: 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)
measure: Differences in pain management between intervention and control group
timeFrame: 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)
measure: Differences in adherence by Medication Possession Ratio (MPR) between intervention and control group
timeFrame: 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)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National Institute of Public Health, University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Holmberg
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Andersen
role: PRINCIPAL_INVESTIGATOR
affiliation: National Research Center for Bone Health
name: Hitz
role: PRINCIPAL_INVESTIGATOR
References: