NCT01587599

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Jun 2010

Typical duration for phase_4 diabetes

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

2.5 years

First QC Date

April 25, 2012

Last Update Submit

April 27, 2012

Conditions

Diabetes

Keywords

pharmaceutical caredrug-related problemselderlyPharmaceutical care of elderly patients with diabetes

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • quality of life

    6 months

  • improved overall health status

    6 months

Study Arms (2)

Pharmaceutical care

ACTIVE COMPARATOR
Behavioral: counseling

Standard care

PLACEBO COMPARATOR
Behavioral: counseling

Interventions

counselingBEHAVIORAL

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

Pharmaceutical careStandard care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Counseling

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Christoph A Ritter, Prof. Dr.

    Ernst-Moritz-Arndt-University Greifswald, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Pharmacy

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 30, 2012

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

April 30, 2012

Record last verified: 2012-04