WestGem study: WESTphalian study on a medication therapy management and home care based intervention under Gender specific aspects in Elderly Multimorbid patients

Prospective, cluster-randomized, controlled trial of effectiveness and costs of a cross-professional and cross-organisational medication therapy management in multimorbid patients with polypharmacy (Prospektive, cluster-randomisierte, kontrollierte Studie zur Untersuchung des Wirksamkeit und der Kosten eines professions- und organisationsübergreifenden Medikationsmanagements bei multimorbiden Patienten mit Polypharmazie)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41595373

Enrollment

240

Registered

2013-10-25

Start date

2013-07-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multimorbidity Not Applicable

Interventions

Randomisation is performed in a stepped wedge design. Participating study sites (general practitioners' offices) are randomized in three groups. The first group starts the inter-professional Medicatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women, aged over 65 years 2. Three or more chronic conditions affecting at least two different organ systems 3. One of the medical conditions must have been existent in three quarters of the last 12 months 4. At least one cardiovascular disease 5. At least one visit to the doctor in each of the last three quarters 6. Five or more long-term medications (> 3 months) with systemic effects 7. Ability to answer questionnaires (with assistance if necessary) 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Estimated life expectancy < 12 months 2. Participation in another clinical trial within the last 30 days

Design outcomes

Primary

Measure	Time frame
Change in the Medication Appropriateness Index (MAI) Scores measured every three months	—

Secondary

Measure	Time frame
1. Quality of life (QoL) measured at baseline and after that every three months 2. Incremental cost-effectiveness ratio 3. Incremental cost-utility ratio 4. Complexity of the pharmacological therapy (Medication Regimen Complexity Index (MRCI), number of pharmaceuticals, daily defined doses) measured every three months 5. Reported patient adherence measured every three months 6. Burden of therapy measured every three months 7. Number of reported (potential) adverse side effects measured every three months 8. Functional status measured every three months 9. Risk of falling measured at baseline and after that every six months 10. Self-reported health measured at baseline and after that every three months 11. Cost of medication therapy measured at baseline and after that every three months 12. Days spent in hospital measured at baseline and after that every three months 13. Cost of illness form the general practitioner´s perspective measured at baseline and after that every three months 14. Quality of medical care provided to vulnerable patient groups	—

Measure

Time frame

1. Quality of life (QoL) measured at baseline and after that every three months 2. Incremental cost-effectiveness ratio 3. Incremental cost-utility ratio 4. Complexity of the pharmacological therapy (Medication Regimen Complexity Index (MRCI), number of pharmaceuticals, daily defined doses) measured every three months 5. Reported patient adherence measured every three months 6. Burden of therapy measured every three months 7. Number of reported (potential) adverse side effects measured every three months 8. Functional status measured every three months 9. Risk of falling measured at baseline and after that every six months 10. Self-reported health measured at baseline and after that every three months 11. Cost of medication therapy measured at baseline and after that every three months 12. Days spent in hospital measured at baseline and after that every three months 13. Cost of illness form the general practitioner´s perspective measured at baseline and after that every three months 14. Quality of medical care provided to vulnerable patient groups

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 16, 2026