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MultimorbidityMM600-DKNCT05676541

Enhanced Care for Patients With Complex Multimorbidity in Primary Care

A study testing Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements in people with Multimorbidity, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction Patients living with a chronic disease often have more than one chronic condition, which is referred to as multimorbidity. Multimorbidity is associated with decreased quality of life, functional decline, polypharmacy, and increased healthcare utilization. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multimorbidity
What is being tested?
Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117,000 participants
Where
1 siteDenmark
Study dates
1 Mar 2023to 31 Dec 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (18 years or older) patients listed at participating GPs living in their own home with
  • Two or more chronic conditions from two of ten diagnosis groups OR who were identified by the GP with complex multimorbidity (see box 1)
  • At least one contact with secondary care in 2022 or 2023.
  • Prescribed at least five prescription drugs

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • General practices in all of Denmark

    Copenhagen, 2700

Other trials in Denmark

About this study

Official title: Effectiveness of an Adaptive, Complex Intervention to Enhance Care for Patients With Complex Multimorbidity in General Practice - a Pragmatic Cluster Randomized Controlled Trial

Introduction Patients living with a chronic disease often have more than one chronic condition, which is referred to as multimorbidity. Multimorbidity is associated with decreased quality of life, functional decline, polypharmacy, and increased healthcare utilization. Patients with multimorbidity often have a high symptom- and treatment burden, and have to attend multiple appointments, often at numerous locations, and comply with complex or even conflicting advice and drug regimens, resulting in an increased risk of depression and low quality of life. In Denmark, general practice is the key organizational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centered care. However, caring for patients with multimorbidity is a complex and time-consuming task and the organization of chronic care in general practice is organized around individual conditions.

Research question The objective of the study is to evaluate the effectiveness of a complex intervention consisting of a prolonged consultation and a strengthened cross-sectoral collaboration for patients with complex multimorbidity listed in participating practices on the patients' health-related quality of life, health and use of health-services.

Read more

Methods

Design:

A pragmatic, adaptive, cluster-randomized, non-blinded, parallel-group trial conducted in general practice in all regions in Denmark evaluating a complex intervention.

Conditions
Multimorbidity
Being tested
Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elementsOther

    The intervention consists of 1) an extended overview consultation lasting 30-45 minutes in general practice, 2) access to cross-sectoral video conferences with secondary care specialists and 3) an instruction material for GPs on how to organize the intervention and 4) an adaptive toolbox to support elements in the intervention (not yet developed)

Study groups in NCT05676541
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Other: Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Needs-based quality of life measured with MMQ1 - PROM

    The primary outcome is needs-based quality of life measured with MMQ1 (unpublished at present). The outcome consist of six unidimensional domains; physical capacity, worries, limitations in daily activities, social life, self-image and economy with a scale from 0-3 per item (sum scores differ due to differences in the number f items) We expect our intervention to be able to affect the three domains; worries, limitations in daily life and social life.

    We will consider a clinically significant improvement in at least one domain as a success.

    Measured: 2 years

Secondary outcomes (13)

  1. Treatment burden (MMQ1-TB) - PROM

    Under validation. The PROM consists of six domains with response categories from 0-3.

    a high score means high burden (negative)

    Measured: 2 years

  2. Patient-perceived patient-centeredness of consultations (PCC-GP) -PROM

    Under validation, The PROM consists of eight domains with response categories from 0-3. a high score means high patient-centeredness (positive)

    Measured: 2 years

  3. Mortality - registry-based

    Number of deaths in each group per patient-years at risk

    Measured: 2 years

  4. Hospitalizations - registry-based

    Number of hospitalizations in each group in total and per patient-years at risk. Any admittance to the hospital counts regardless if it is planned or unplanned and regardless the duration.

    Measured: 2 years

  5. Nursing home placement registry-based

    Number of nursing home placements in each group in total and per patient year at risk

    Measured: 2 years

  6. number of prescription medicines - registry-based

    Number of prescription medicines per patient in each group (as a count regardless indication)

    Measured: 2 years

  7. Polypharmacy - registry-based

    Number of patients with polypharmacy (more than 5 prescription drugs) in each group

    Measured: 2 years

  8. GP work satisfaction related to care for patients with multimorbidity - questionnaire

    We have developed six items regarding work satisfaction/burden in relation to working with patients with MM in general practice. A clinically significant difference between the groups in at least one of the items will be considered a success.

    Measured: 2 years

  9. GP burn-out - questionnaire

    If we get access to the national GP burnout questionnaire data, we will use the data to report this outcome. But the outcome depends on the questionnaire being distributed at an appropriate time which is not currently yet planned.

    Measured: 2 years

  10. Use of health services in general practice registry-based

    This outcome combines all use of health services in general practice regardless contact form. It will be measured as number of contacts

    Measured: 2 years

  11. Use of other primary care health services (such as private specialists and out-of-hours care) registry-based.

    All contacts in primary care will be combined and the number of contacts compared between groups

    Measured: 2 years

  12. Use of outpatient and other planned health services in secondary care (including new referrals), registry-based

    All contacts in secondary care will be combined and the number of contacts compared between groups

    Measured: 2 years

  13. Health service use in the municipalities - registry-based

    All contacts in the municipalities regarding health and rehabilitation will be combined and the number of contacts compared between groups

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start1 Mar 2023
  3. Primary completion29 Oct 2025
  4. Study completion31 Dec 2025

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized
Masking
None (open label)
Enrolment
117,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05676541
Sponsor's protocol ID
UCopenhagen-MM600
Acronym
MM600-DK
Status last verified
Feb 2026
First submitted
16 Dec 2022
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Larsen HH, Willadsen TG, Prior A, Lyhnebeck AB, Waldorff FB, Holm A. Methods and baseline results of the Cohort of Health-Related Outcomes in Chronic Illness Care in General Practice in Denmark (CHRONIC-GP). BMJ Open. 2025 Nov 26;15(11):e103807. doi: 10.1136/bmjopen-2025-103807.

    PubMed 41298265

  • Lyhnebeck AB, Holm A, Buhl SF, Bissenbakker KH, Kristensen JK, Moller A, Prior A, Kamper-Jorgensen Z, Bocher S, Kristensen M, Waagepetersen A, Dalsgaard AH, Siersma V, Brodersen JB; MM600 trial group. Measuring treatment burden related to general practice in patients with multimorbidity: development and validation of a PROM. Fam Med Community Health. 2025 Aug 17;13(3):e003378. doi: 10.1136/fmch-2025-003378.

    PubMed 40819910

  • Holm A, Lyhnebeck AB, Buhl SF, Bissenbakker K, Kristensen JK, Moller A, Prior A, Kamper-Jorgensen Z, Bocher S, Kristensen MAT, Waagepetersen A, Dalsgaard AH, Siersma V, Guassora AD, Brodersen JB; on behalf MM600 trial group. Development of a PROM to measure patient-centredness in chronic care consultations in primary care. Health Qual Life Outcomes. 2025 Jan 8;23(1):4. doi: 10.1186/s12955-024-02327-x.

    PubMed 39780227

  • Holm A, Lyhnebeck AB, Rozing M, Buhl SF, Willadsen TG, Prior A, Christiansen AL, Kristensen J, Andersen JS, Waldorff FB, Siersma V, Brodersen JB, Reventlow S; MM600 project team. Effectiveness of an adaptive, multifaceted intervention to enhance care for patients with complex multimorbidity in general practice: protocol for a pragmatic cluster randomised controlled trial (the MM600 trial). BMJ Open. 2024 Feb 2;14(2):e077441. doi: 10.1136/bmjopen-2023-077441.

    PubMed 38309759

Questions about this trial

What is this clinical trial studying?

A study testing Complex intervention to enhance care for patients with multimorbidity in general practice consisting of an extended overview consultation and supporting elements in people with Multimorbidity, run by University of Copenhagen at 1 site in Denmark.

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 4 inclusion and 0 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 20 Feb 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 Denmark. 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?

Needs-based quality of life measured with MMQ1 - PROM (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05676541, which also lists 4 linked publications.

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 20 Feb 2026.

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