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

NCT ID: NCT01587599

Last Updated: 2012-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-03-31

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.

Detailed Description

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Conditions

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Diabetes

Keywords

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pharmaceutical care drug-related problems elderly Pharmaceutical care of elderly patients with diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pharmaceutical care

Group Type ACTIVE_COMPARATOR

counseling

Intervention Type BEHAVIORAL

The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.

Standard care

Group Type PLACEBO_COMPARATOR

counseling

Intervention Type BEHAVIORAL

The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.

Interventions

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counseling

The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foerderinitiative Pharmazeutische Betreuung e.V.

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Christoph Ritter

Professor of Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph A Ritter, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Ernst-Moritz-Arndt-University Greifswald, Germany

Other Identifiers

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FI_CLIN_PHARM_EMAU_01

Identifier Type: -

Identifier Source: org_study_id