Condition category
Not Applicable
Date applied
18/05/2009
Date assigned
07/07/2009
Last edited
28/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christiane Muth

ORCID ID

Contact details

Institute for General Practice
Johann Wolfgang Goethe University
Theodor-Stern-Kai 7
Frankfurt
60590
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GK0702

Study information

Scientific title

Prioritising and optimising multiple medications in elderly multi-morbid patients in general practice: a pilot open-label two-arm cluster-randomised controlled trial

Acronym

PRIMUM pilot

Study hypothesis

The aim of this pilot study is to test the feasibility of a complex intervention in the general practice on the appropriateness of medication in elderly multi-morbid patients and the feasibility of a cluster-randomised controlled trial.

Ethics approval

Ethics Committee of Medicine, Johann Wolfgang-Goethe University, Frankfurt, 24/03/2009, ref: 54/09

Study design

Pilot open-label two-arm cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Multi-medication in elderly multi-morbid patients

Intervention

The trial has two arms: one intervention arm and one control arm.

The intervention consists of several components:
1. Medication reconciliation (brown-bag review)
2. Structured interview lead by practice nurse on problems related to medications based on a checklist (medication monitoring list, MediMoL)
3. Use of a computerised decision support system on medications (AiD+)
4. Counselling session with GP on medication-related problems
The total duration of the intervention is three weeks.

Practices in the control arm procede as usual (i.e. there is no sham control).

The duration of the follow-up period (which starts after the second data collection) is six weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. To evaluate practicability: expenditure of time regarding intervention
2. To evaluate feasibility: number of patients who dropped out, reasons for why patients do not participate in study, time expenditure regarding data collection
3. Potential primary outcome for main study: appropriateness of medication (Medication Appropriateness Index [MAI])

There are three timepoints of data collection in both, the control and the intervention arm:
T0: before the beginning of the intervention
T1: six weeks after the beginning of the intervention
T2: twelve weeks after the beginning of the intervention

Secondary outcome measures

1. Complexity of medication (number of drugs, number of daily doses, Medication Regimen Complexity Index [MRCI])
2. Observed adherence (drug score, dose score, regimen score)
3. Reported adherence (Medication Adherence Report Scale [MARS] and adherence according to Morisky)
4. Patient attitude toward medication (Beliefs about Medicines Questionnaire [BMQ])
5. Patient satisfaction regarding information about medication
6. Health related quality of life (EQ-5D)
7. Functional disability (World Health Organization Disability Assessment Schedule II [WHO-DASII])
8. Pain (Verbal Rating Scale)
9. Hospital days
10. Number of medication side effects

There are three timepoints of data collection in both, the control and the intervention arm:
T0: before the beginning of the intervention
T1: six weeks after the beginning of the intervention
T2: twelve weeks after the beginning of the intervention

Overall trial start date

13/05/2009

Overall trial end date

03/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. At least 65 years old, either sex
2. At least three chronic diseases
3. At least five continuous prescriptions
4. At least one practice visit during the last quarter
5. Written informed consent
6. Ability to fill out a questionnaire and participate in a telephone interview

Practices:
1. Practice serves members of the German statutory health insurance system
2. GP practice
3. Physician is specialised in general practice or internal medicine, or without specialisation
4. Internet access
5. Availability of a practice nurse who can participate in the study

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

100

Participant exclusion criteria

Patients:
1. Life expectancy of less than six months
2. Drug addiction problems
3. Cognitive impairment (Mini Mental State Examination [MMSE] score less than 26)
4. Emotional stress that would prevent participation in the study
5. Participation in a clinical trial within the last 30 days

Recruitment start date

13/05/2009

Recruitment end date

03/11/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Johann Wolfgang Goethe University
Frankfurt
60590
Germany

Sponsor information

Organisation

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)

Sponsor details

Hannoversche Strasse 28-30
Berlin
10115
Germany

Sponsor type

Government

Website

http://www.bmbf.de

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung (ref: 01GK0702)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27456328

Publication citations

Additional files

Editorial Notes

28/07/2016: Publication reference added.