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临床试验/NCT00414154
NCT00414154已完成早期 1 期

The Effect of a Group Based Multidisciplinary Patient Education Programme for Patients With Osteoporosis - a Controlled Randomised Trial

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2002年5月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
300
试验地点
2
主要终点
Level of compliance to pharmacological treatment

研究概览

简要总结

Modification of individual life style factors and fall prevention programmes may have significant positive effects on fracture incidence. Also, a large number of studies have demonstrated that pharmacological therapy of osteoporosis is effective; however non-adherence to such therapy is a well recognized problem. Few studies, however, have examined the effect of particular patient education programmes on knowledge and adherence to therapy.

We hypothesised that a group-based, multi-disciplinary, education programme increases the total quality of treatment for patients with osteoporosis, Patients' knowledge on osteoporosis and adherence with pharmacological therapy ect.

A total of 300 patients, recently diagnosed with osteoporosis and started on specific treatment, were randomised to either the "school" or "control" group. In the school-group, patients attended four classes with 8-12 participants during four weeks (a total of 12 hours). Teaching was performed by nurses, physiotherapists, dieticians, and doctors and was based on dialogs and situated learning. The classes covered "facts on osteoporosis", "fractures and pain", "diet", "preventive measures", "balance and exercise", and "medical treatment". Teaching was designed to increase empowerment. The control group were offered the department's standard treatment including follow-up visits.

All 300 patients received questionnaires regarding "Knowledge about Osteoporosis", "Level of Adherence", "Quality of life", "Dietary calcium intake", "Level of physical activity", "Falls events" registered every month by postcard, at inclusion and after 3, 12, and 24 month. BMD was examined by DXA-scan at inclusion and after 12 and 24 month. The last patient will answer the questionnaires first of May 2007.

研究设计

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

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and female age 45-80,
  • Diagnosed with osteoporosis and started medical treatment

排除标准

  • Severe illness,
  • Cognitive dysfunction,
  • Not able to speak or read Danish

结局指标

主要结局

Level of compliance to pharmacological treatment

次要结局

  • Level of physical activity,
  • Daily dietary calcium intake,
  • registration of fall in and outdoor,
  • Quality of life,
  • Knowledge on Osteoporosis, BMD

研究者

申办方类型
Other

研究点 (2)

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