Actively Recruiting
Reducing Medication Risks in Elderly People With Multiple Diseases A Stepped Wedge Cluster Randomized Trial Evaluating Medication Review and Adherence Support
Led by Martin-Luther-Universität Halle-Wittenberg · Updated on 2025-01-09
1146
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
M
Martin-Luther-Universität Halle-Wittenberg
Lead Sponsor
U
University of Leipzig
Collaborating Sponsor
AI-Summary
What this Trial Is About
Many elderly patients with multiple chronic diseases are treated with five or more medications at the same time, which increases their risk of adverse drug reactions (ADRs). These inappropriate prescriptions can lead to serious problems like falls, hospitalizations, and even death. This study aims to test a new approach to reduce the frequency of ADRs in patients aged 70 years and older who have multiple health conditions and are taking many medications. The study involves a special intervention where patients receive a detailed review of their medications by an external pharmacologist using established criteria to identify potentially inappropriate drugs. This updated medication plan is then given to the patient's family doctor to discuss and implement. In addition, patients receive support from a study nurse through phone calls using motivational interviewing to help improve medication adherence and inform them about the risks of not taking medications properly or signs of side effects. The control group continues with their usual care without these added supports. Participants will be monitored for six months after the intervention to track the rate of adverse drug reactions. Researchers will also assess other factors such as hospitalizations related to medication issues, how well patients stick to their medication plans, quality of life, and the number of inappropriate prescriptions. The study is being conducted across 40 primary care practices in Germany and plans to include 1,146 patients. The goal is to find effective ways to reduce medication-related problems in older adults with multiple health conditions.
CONDITIONS
Official Title
Reduction of Polypharmacy in Elderly People With Multiple Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Taking five or more long-term medications (over 6 months) (polypharmacy)
- Having three or more chronic diseases (multimorbidity)
- At least one family doctor consultation within the last 6 months
You will not qualify if you...
- Critically reduced life expectancy
- Unable to visit the family practice independently
- Unable to participate in the informed consent process
- Living in a nursing home
- Diagnosed with dementia or mental/behavioral disorders (ICD-10 F00-F99)
- Currently participating in another medical study focused on polypharmacy or multimorbidity
AI-Screening
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Trial Site Locations
Total: 1 location
1
HAP ANZ
Halle, Saxony-Anhalt, Germany, 06110
Actively Recruiting
Research Team
A
Alexander Bauer, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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