Overview

This trial is active, not recruiting.

Condition diabetes
Treatment counseling
Phase phase 4
Sponsor Foerderinitiative Pharmazeutische Betreuung e.V.
Start date June 2010
End date December 2012
Trial size 54 participants
Trial identifier NCT01587599, FI_CLIN_PHARM_EMAU_01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
counseling
The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.
(Placebo Comparator)
counseling
The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.

Primary Outcomes

Measure
adherence
time frame: 6 months
adverse events
time frame: 6 months
drug-drug-interactions
time frame: 6 months

Secondary Outcomes

Measure
quality of life
time frame: 6 months
improved overall health status
time frame: 6 months

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

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
Principal investigator Christoph A Ritter, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Foerderinitiative Pharmazeutische Betreuung e.V..