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临床试验/NCT01587599
NCT01587599Unknown4 期

Pharmaceutical Care of Elderly Diabetes-patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services in North-eastern Germany

Foerderinitiative Pharmazeutische Betreuung e.V.0 个研究点目标入组 54 人开始时间: 2010年6月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
54
主要终点
adherence

研究概览

简要总结

Design and Procedure:

The design is a randomised controlled multi-centre pilot study. 18 community pharmacies located in Mecklenburg-Western Pomerania, Germany, were randomised to either a control or an intervention group. These pharmacies recruited eligible patients out of their clientele and invited them to take part in the study. Participants were visited at home by the pharmacist and home-based medication reviews were conducted. The survey form has been developed by the research team and comprised amongst others items to adherence, adverse effects, drug intake, storage and quality of life. Thereafter all data were analysed by the pharmacist with a newly developed document called "analysis guide" aiming at the detection of drug related problems. Pharmacists of the intervention group discussed the results with the family doctor of the patients and the patients and tried to solve the drug related problems. This procedure was not undertaken in the control group.

Six months later a second medication review was carried out in both groups.

Study hypothesis:

Pharmaceutical care reduces the overall number of drug-related problems of elderly patients with diabetes and impairments in mobility.

Aim:

The purpose of this study is to show that pharmaceutical care reduces the overall number of drug-related problems of elderly diabetes-patients with impairments in mobility and leads to both an improved health status and an improved quality of life.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • impairment in mobility
  • age of 65 years or older
  • four or more long-term medications
  • at least one of the following co-morbidities: hypertension, obesity, hypercholesteremia, hyperlipidemia, coronary heart disease, cardiac insufficiency, angina pectoris, peripheral vascular disease

排除标准

  • patient lives in a home for the aged or a residential care home for the elderly
  • terminal renal failure, dialysis
  • moderately or severe dementia or other severe cognitive impairments
  • terminal diseases (e.g. cancer)
  • nursing service if the medicine is directly administered to the patient

结局指标

主要结局

adherence

时间窗: 6 months

MMAS-8d

adverse events

时间窗: 6 months

SHIP-trend 8-items questionnaire

drug-drug-interactions

时间窗: 6 months

ABDATA drug-drug interaction identification tool

次要结局

  • quality of life(6 months)
  • improved overall health status(6 months)

研究者

发起方
Foerderinitiative Pharmazeutische Betreuung e.V.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Christoph Ritter

Professor of Clinical Pharmacy

Foerderinitiative Pharmazeutische Betreuung e.V.

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