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临床试验/NCT05401968
NCT05401968已完成不适用

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

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 3,132 人开始时间: 2022年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3,132
试验地点
1
主要终点
Differences in quality of life between intervention and control group

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • To participate in osteoporosis patient education in municipalities the participants should have osteoporosis or in few cases osteopenia.

排除标准

  • None though this may vary across municipalities

研究组 & 干预措施

Intervention group

Experimental

Osteoporosis patients who have participated in patient education

干预措施: Osteoporosis patient education (Behavioral)

Control group

No Intervention

Osteoporosis patients who have not participated in patient education

结局指标

主要结局

Differences in quality of life between intervention and control group

时间窗: 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 clinical diagnosis of fracture between intervention and control group

时间窗: 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

次要结局

  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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