PolypharmacyREDNCT05526963
Reduction of Polypharmacy in Elderly People With Multiple Diseases
A study testing Medication plan review and Adherence support in people with Polypharmacy and Multimorbidity, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
Elderly GP patients are often treated with five or more medications and therefore prone to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Polypharmacy, Multimorbidity
- What is being tested?
- Medication plan review and Adherence support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteGermany
- Study dates
- 30 May 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥ 5 longterm medications (> 6 months) (polypharmacy)
- ≥ 3 chronic diseases (multimorbidity)
- ≥ 1 family doctor consultation within the last 6 months
Who cannot join
- Patients with a critically reduced life expectancy
- Patients who cannot autonomously visit the family practice
- Patients who cannot participate in the informed consent process
- Patients who are residing in a nursing home
- Patients with dementia or a mental of behavioral disorder ICD-10 F00-F99
- Patients who are participating in another medical study with a focus on polypharmacy or multimorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Polypharmacy in Elderly People With Multiple Diseases - a Stepped Wedge Cluster-randomized Controlled Trial
Elderly GP patients are often treated with five or more medications and therefore prone to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. The primary aim of this study to reduce the frequency of ADRs in multimorbid patients aged 70 years and older by reducing polypharmacy.
Read the detailed description
Introduction: Many elderly people are multimorbid and are treated with five or more medications (polypharmacy) at the same time. Due to age related physiological changes they are especially vulnerable to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. Up to 16% of unplanned hospitalizations of elderly people with polypharmacy are caused by ADRs. The primary aim of this study is the evaluation of the effectivity of a multi-component-intervention to reduce the frequency of ADRs in multimorbid patients aged 70 years and older.
Methods: We are planning a multi-center stepped wedge cluster randomized controlled trial at 40 primary care practices affiliated to the RaPHaeL-network (Research Practices Halle-Leipzig) in Saxony-Anhalt and Saxony, Germany. The planned intervention follows the recommendations of the New Medical Research Council and comprises a pharmacological medication plan review according to the STOPP/START-criteria and an adherence support measure employing motivational interviewing. Control group will receive usual care. Eligible patients are ≥ 70 years old, are diagnosed with three or more chronic medical conditions and are prescribed five or more medications. The primary outcome is the rate of ADRs six months post intervention. The secondary outcomes are number of ADRs, hospitalization rate due to ADRs, medication adherence, the health-related quality of life (Euro-QOL EQ-5D-5L), the number of PIPs (according to STOPP/START), number of primary care physician per quarter, the medication appropriateness index and the mean number of de-prescriptions per patient. The planned sample size is 1,146 patients.
Discussion: Multimorbid patients with polypharmacy show an increased risk for PIPs, since prescriptions can be based on evidence for pharmacological therapy of a single condition without taking into account the complex drug interactions. Based on the existing evidence we are aiming to reduce ADRs in this patient population.
- Conditions
- Polypharmacy, Multimorbidity
- Being tested
- Medication plan review, Adherence support
- Keywords
- Primary Care, Polypharmacy, Multimorbidity, Drug-Related Side Effects and Adverse Reactions
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication plan reviewOther
Intervention group patients will receive a revised medication plan by external pharmacologist based on the the STOPP/START criteria. The revised medication plan will be provided to the family physician who then will provide it to the patient. The revision comes along with evidence based information for the physician to prevent possible uncertainties by the physicians.
Adherence supportBehavioural
Intervention group patients will receive a study nurse administered adherence support measure based on telephone-based motivational interviewing. The measure includes information on possible consequences of inadherence and signs of adverse drug reactions that is comprehensible for lay persons.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Medication review (STOPP/START-criteria) + telephone-based adherence support measure (motivational interviewing) Receives: Other: Medication plan review; Behavioral: Adherence support |
| Control Group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of drug-related problems
Rate of sdrug-related problems per patient based on a list of commonly reported drug-related symptoms in primary care.
Measured: 6 months
Secondary outcomes (7)
Potentially inappropriate prescriptions
The number of potentially inappropriate prescriptions based on the STOPP(Screening Tool of Older Persons' potentially inappropriate Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) criteria.
Measured: 6 months
Hospitalizations
The frequency of hospitalizations due to adverse drug reactions.
Measured: 6 months
Adherence
The patient's adherence to the medication plan is assessed per prescription. Response categories are yes/no for each prescription with a dichotomous response . The summed total score will be been categorized into two levels of adherence: high adherence (equals complete adherence), and low adherence (non-adherence in any form).
Measured: 6 months
Health-related quality of life
The health-related quality of life will be measured using the six-item European Quality of Life 5 Dimensions 3 Level Version (Euro-QOL EQ-5D-5L) tool, ranging from 0 to 100 on a visual analoge scale with higher values indicating a higher quality of life.
Measured: 6 months
Medication appropriateness
The medication appropriateness will be measured using the medication appropriateness index (MAI)
Measured: 6 months
Deprescription
The number of medication de-prescriptions per patient
Measured: 6 months
Types of adverse drug reactions
Number and types of self-reported adverse drug reactions per patient based on a list of commonly reported drug-related symptoms in primary care. Each symptom's severity will be quantified by use of an analogue scale from 0 (no severity) to 10 (maximum imaginable severity)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start30 May 2024
- Primary completion30 May 2026
- Study completion31 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge cluster-randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, Hannover Medical School
- Responsible party
- Principal investigator, Alexander Bauer, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Thomas Frese, Prof., Study chair, MLU Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526963
- Sponsor's protocol ID
- RaPHaeL_001_RED
- Acronym
- RED
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2022
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Polypharmacy in Elderly People With Multiple Diseases - a Stepped Wedge Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05526963
- Acronym / sponsor ID
- RED / RaPHaeL_001_RED
- Conditions
- Polypharmacy, Multimorbidity
- Keywords
- Primary Care, Polypharmacy, Multimorbidity, Drug-Related Side Effects and Adverse Reactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- University of Leipzig, Hannover Medical School
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 31 Oct 2026 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elderly GP patients are often treated with five or more medications and therefore prone to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. The primary aim of this study to reduce the frequency of ADRs in multimorbid patients aged 70 years and older by reducing polypharmacy.
Detailed description
Introduction: Many elderly people are multimorbid and are treated with five or more medications (polypharmacy) at the same time. Due to age related physiological changes they are especially vulnerable to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. Up to 16% of unplanned hospitalizations of elderly people with polypharmacy are caused by ADRs. The primary aim of this study is the evaluation of the effectivity of a multi-component-intervention to reduce the frequency of ADRs in multimorbid patients aged 70 years and older.
Methods: We are planning a multi-center stepped wedge cluster randomized controlled trial at 40 primary care practices affiliated to the RaPHaeL-network (Research Practices Halle-Leipzig) in Saxony-Anhalt and Saxony, Germany. The planned intervention follows the recommendations of the New Medical Research Council and comprises a pharmacological medication plan review according to the STOPP/START-criteria and an adherence support measure employing motivational interviewing. Control group will receive usual care. Eligible patients are ≥ 70 years old, are diagnosed with three or more chronic medical conditions and are prescribed five or more medications. The primary outcome is the rate of ADRs six months post intervention. The secondary outcomes are number of ADRs, hospitalization rate due to ADRs, medication adherence, the health-related quality of life (Euro-QOL EQ-5D-5L), the number of PIPs (according to STOPP/START), number of primary care physician per quarter, the medication appropriateness index and the mean number of de-prescriptions per patient. The planned sample size is 1,146 patients.
Discussion: Multimorbid patients with polypharmacy show an increased risk for PIPs, since prescriptions can be based on evidence for pharmacological therapy of a single condition without taking into account the complex drug interactions. Based on the existing evidence we are aiming to reduce ADRs in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Medication plan review, Behavioral: Adherence supportMedication review (STOPP/START-criteria) + telephone-based adherence support measure (motivational interviewing) |
| Control Group | No intervention | –Usual care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥ 5 longterm medications (> 6 months) (polypharmacy)
- ≥ 3 chronic diseases (multimorbidity)
- ≥ 1 family doctor consultation within the last 6 months
Key exclusion criteria (6 listed)
- Patients with a critically reduced life expectancy
- Patients who cannot autonomously visit the family practice
- Patients who cannot participate in the informed consent process
- Patients who are residing in a nursing home
- Patients with dementia or a mental of behavioral disorder ICD-10 F00-F99
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication plan reviewIntervention group patients will receive a revised medication plan by external pharmacologist based on the the STOPP/START criteria. The revised medication plan will be provided to the family physician who then will provide it to the patient. The revision comes along with evidence based information for the physician to prevent possible uncertainties by the physicians. | Other | Intervention Group |
| Adherence supportIntervention group patients will receive a study nurse administered adherence support measure based on telephone-based motivational interviewing. The measure includes information on possible consequences of inadherence and signs of adverse drug reactions that is comprehensible for lay persons. | Behavioural | Intervention Group |
Primary outcome
Rate of drug-related problems
Time frame: 6 months
Rate of sdrug-related problems per patient based on a list of commonly reported drug-related symptoms in primary care.
7 secondary outcomes
Potentially inappropriate prescriptions
Time frame: 6 months
Hospitalizations
Time frame: 6 months
Adherence
Time frame: 6 months
Health-related quality of life
Time frame: 6 months
Medication appropriateness
Time frame: 6 months
Deprescription
Time frame: 6 months
Types of adverse drug reactions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Frese, Prof. study chair
MLU Halle-Wittenberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication plan review and Adherence support in people with Polypharmacy and Multimorbidity, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of drug-related problems (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.