Pharmaceutical Care of Patients With Impaired Mobility in a Model-region of Decreasing Supply of Medical Services

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharmaceutical care<br> | Behavioral: counseling<br>* The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.<br>|
| Placebo Comparator: Standard care<br> | Behavioral: counseling<br>* The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence | MMAS-8d | 6 months | 
| adverse events | SHIP-trend 8-items questionnaire | 6 months | 
| drug-drug-interactions | ABDATA drug-drug interaction identification tool | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | improvement of quality of life, measured with eq-5d | 6 months | 
| improved overall health status |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmaceutical care, drug-related problems, elderly, Pharmaceutical care of elderly patients with diabetes