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

Phase 4

• Conditions: Diabetes
• Interventions: Behavioral: counseling

• Registration Number: NCT01587599
• Lead Sponsor: Foerderinitiative Pharmazeutische Betreuung e.V.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Status Verified: 2012-04
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-27
• Last Update Submitted: 2012-04-27
• Study First Posted: 2012-04-30
• Last Update Posted: 2012-04-30
• Primary Completion: 2012-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmaceutical care	counseling	-
Standard care	counseling	-

Primary Outcome Measures

Name	Time	Method
adherence	6 months	MMAS-8d
adverse events	6 months	SHIP-trend 8-items questionnaire
drug-drug-interactions	6 months	ABDATA drug-drug interaction identification tool

Secondary Outcome Measures

Name	Time	Method
quality of life	6 months	improvement of quality of life, measured with eq-5d
improved overall health status	6 months