Clinical trial NCT01587599: Pharmaceutical Care of Patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services
Official title: Pharmaceutical Care of Elderly Diabetes-patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services in North-eastern Germany
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes
Keywords: pharmaceutical care
drug-related problems
elderly
Pharmaceutical care of elderly patients with diabetes
Lead sponsor: Foerderinitiative Pharmazeutische Betreuung e.V.
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: adherence
timeFrame: 6 months
measure: adverse events
timeFrame: 6 months
measure: drug-drug-interactions
timeFrame: 6 months
Secondary outcomes:
measure: quality of life
timeFrame: 6 months
measure: improved overall health status
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Ernst-Moritz-Arndt-University Greifswald, Germany
name: Christoph A Ritter, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: