NCT07819383

Brief Summary

Cardiovascular disease, high blood pressure, chronic kidney disease, and type 2 diabetes, collectively referred to as Cardio-Renal-Metabolic (CRM) conditions, are among the most common chronic diseases in society. In Sweden, approximately 2.5 million people live with high blood pressure, one million have impaired kidney function, and more than half a million live with diabetes or heart disease. Many individuals are affected by more than one of these conditions at the same time, meaning that up to 30% of patients registered at an average primary care practice belong to this group. These diseases are closely interconnected. Developing one condition substantially increases the risk of developing another, and the risk of cardiovascular events and other complications rises sharply as the number of diagnoses increases. As people live longer, it is becoming increasingly common for older adults to live with several chronic diseases simultaneously. This places a considerable burden on healthcare systems, both medically and economically. At the same time, there is strong evidence that early, coordinated interventions can slow disease progression and reduce the risk of future complications. Despite clear national guidelines, there is still room for improvement in clinical practice. One important reason is that healthcare services and treatment guidelines remain largely organized around individual diagnoses rather than around the overall needs of each patient. As a result, different specialists often work in parallel, sometimes pursuing different treatment goals and strategies. This can lead to both under-treatment and over-treatment, contributing to unequal care and unnecessary burden for patients. The CRM Centre at Danderyd Hospital provides an example of how integrated care can work in practice. There, assessment, treatment, and follow-up are delivered by a multidisciplinary team that takes the patient's entire disease profile into account. The model has produced promising results for patients with more complex medical needs. However, the vast majority of people with CRM-related conditions are managed within primary care. This study evaluates a new primary care model that builds on the experience gained from the CRM Centre at Danderyd Hospital. The aim is to bring together all patients with CRM diagnoses within a common care structure and a unified treatment strategy. Participating primary care centres will receive education and access to practical support materials that integrate recommendations from guidelines covering all three disease areas. An important component is strengthened collaboration between primary and specialist care. Participating centres will have opportunities for clinical observerships, multidisciplinary digital case conferences with specialists at Danderyd Hospital, and targeted consultations regarding patients with CRM conditions through the Department of Internal Medicine at Ersta Hospital. The project will be integrated into routine clinical practice without requiring additional patient visits. All patient management will be carried out by the responsible healthcare professionals, supported by the educational programme, clinical tools, and collaboration with specialist services. Using electronic health record data, national registers, and health economic analyses, the study will evaluate whether the model improves the use of evidence-based medications, increases achievement of treatment targets, and enhances cost-effectiveness. Long-term outcomes, including survival and rates of hospital admission, will also be assessed. By bringing together care from multiple perspectives, this project addresses a clear and growing clinical need: providing patients with CRM conditions with more coordinated, effective, and equitable care. The findings are expected to be directly applicable across primary care and could inform future models for managing multimorbidity on a broader scale.

Trial Health

65
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Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
60mo left

Started Sep 2026

Longer than P75 for all trials

Status
not yet recruiting

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 Progress1%
Sep 2026Sep 2031

First Submitted

Initial submission to the registry

September 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

September 16, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2028

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2031

Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 9, 2026

Last Update Submit

September 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • CRM quality index

    To quantify the effect of patient-centered CRM care on guidelines-based health care quality with a special focus on cardiorenal protective treatment in clinical praxis.

    1,5 years

Study Arms (1)

CRM care

Other: CRM care

Interventions

The study investigates a model of care

CRM care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with diagnoses within cardiovascular, kidney disease and type 2 diabetes, registered at units included in the study, with at least one visit during the study period

You may qualify if:

  • all patients with diagnoses within cardiovascular, kidney disease and type 2 diabetes, registered at units included in the study, with at least one visit during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Kristina Lundwall, MD, PhD

CONTACT

Ladan Mansouri, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 14, 2026

Study Start

September 16, 2026

Primary Completion (Estimated)

September 16, 2028

Study Completion (Estimated)

September 16, 2031

Last Updated

September 14, 2026

Record last verified: 2026-09