- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01587599
Pharmaceutical Care of Patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services
Pharmaceutical Care of Elderly Diabetes-patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services in North-eastern Germany
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- impairment in mobility
- age of 65 years or older
- four or more long-term medications
- diabetes
- at least one of the following co-morbidities: hypertension, obesity, hypercholesteremia, hyperlipidemia, coronary heart disease, cardiac insufficiency, angina pectoris, peripheral vascular disease
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Standard care
|
The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.
|
Active Comparator: Pharmaceutical care
|
The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adherence
Time Frame: 6 months
|
MMAS-8d
|
6 months
|
adverse events
Time Frame: 6 months
|
SHIP-trend 8-items questionnaire
|
6 months
|
drug-drug-interactions
Time Frame: 6 months
|
ABDATA drug-drug interaction identification tool
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life
Time Frame: 6 months
|
improvement of quality of life, measured with eq-5d
|
6 months
|
improved overall health status
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christoph A Ritter, Prof. Dr., Ernst-Moritz-Arndt-University Greifswald, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FI_CLIN_PHARM_EMAU_01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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