Pharmaceutical Care of Elderly Diabetes-patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services in North-eastern Germany
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 54
- Primary Endpoint
- adherence
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
Outcomes
Primary Outcomes
adherence
Time Frame: 6 months
MMAS-8d
adverse events
Time Frame: 6 months
SHIP-trend 8-items questionnaire
drug-drug-interactions
Time Frame: 6 months
ABDATA drug-drug interaction identification tool
Secondary Outcomes
- quality of life(6 months)
- improved overall health status(6 months)
Investigators
Prof. Dr. Christoph Ritter
Professor of Clinical Pharmacy
Foerderinitiative Pharmazeutische Betreuung e.V.