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Integrated, Multidisciplinary, Person-centered Care for Patients With Complex Comorbidities: Heart, Kidney and Diabetes (CareHND)

This study is currently recruiting participants.
Verified November 2017 by Jonas Spaak, Danderyd Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03362983
First Posted: December 5, 2017
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Karolinska Institutet
University of British Columbia
Information provided by (Responsible Party):
Jonas Spaak, Danderyd Hospital
  Purpose
Patient with complex comorbidities present a growing challenge for health-care providers, that the current system is poorly designed to handle. Concomitant cardiovascular disease, renal dysfunction and diabetes represent almost half of all patients attending cardiac, kidney and diabetes clinics. Patients with all three of these will be randomized to standard care or to a combined, integrated, person-centered, intensified chronic disease management.

Condition Intervention
Diabetes Mellitus Chronic Kidney Diseases Cardiovascular Diseases Chronic Disease Multimorbidity Other: CareHND

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated, Multidisciplinary, Person-centered Care for Patients With Complex Comorbidities: Heart, Kidney and Diabetes - a Randomized Trial

Further study details as provided by Jonas Spaak, Danderyd Hospital:

Primary Outcome Measures:
  • Disease progression (n=260) [ Time Frame: 2 years ]
    Combined death or readmission due to heart failure, myocardial infarction, PCI/CABG, end stage renal failure, acute renal failure or TIA / stroke.

  • Patient centered outcome measures (n=131) [ Time Frame: 1 year ]
    Perceived quality of care and patient empowerment assessed by a PROMs (Patient Reported Outcome Measure) questionaire with a sum score.

  • Quality-of-care outcome measures (n=131) [ Time Frame: 1 year ]
    Combined score of achieved target blood pressure, target HbA1C and target LDL.


Secondary Outcome Measures:
  • Organ damage (n=131) [ Time Frame: 1 year ]
    Decline in eGFR

  • System biology (n=131) [ Time Frame: 1 year ]
    Changes in markers of disease progression in transcriptomics, proteomics and metabolomics.

  • Health care structure and utilization (n=131) [ Time Frame: 1 year. ]
    Health care utilization measured by number of outpatient and inpatient contacts

  • Patient safety (n=131) [ Time Frame: 1 year ]
    Using logged patient safety reports.

  • Interdisciplinary learning (n=20) [ Time Frame: 1 year ]
    Qualitative analysis of interdisciplinary learning between personnel.


Estimated Enrollment: 260
Actual Study Start Date: January 1, 2016
Estimated Study Completion Date: March 1, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Care HND Intervention
Integrated, multidisciplinary, person centered care at HND-centrum.
Other: CareHND
Multidisciplinary, integrated, person-centered care at the integrated HND-clinic
No Intervention: Standard care
Standard care at separate specialty clinics and primary care as needed.

Detailed Description:

Patients with concomitant cardiovascular disease, renal dysfunction and diabetes represent almost half of all patients attending cardiac, kidney and diabetes clinics, and about 15 % suffer all three. This proportion of patients with multiple chronic conditions increase markedly by age. These complicated diseases interact, and treatment of one affect the others. Despite this have a progressive subspecialisation caused cardiologist to treat "only" the heart, nephrologists "only" the kidneys and endocrinologists' "only" diabetes. Studies and guidelines follow the same pattern. At best this require patients to visit specialists in each field; at worst result in redundant examinations, under-diagnosis and under-treatment of comorbidities. From the patient perspective, there is a great need for coordination and improvement of the care, not only to reduce disease progression but also to optimise quality of life.

We aim to study if the treatment and outcome for patients with concomitant cardiovascular disease, renal dysfunction and diabetes can be improved through a new model to deliver healthcare. We have designed an integrated clinic to handle all three conditions at the same visit, with a person-centered team-based approach between patients, nurses and physicians, with bi-weekly therapy conferences by dedicated and educated cardiologists, nephrologists and endocrinologists. At these, optimised care-plans are developed, and at following team-visits and phone contacts, these are implemented.

The intervention will be studied in a randomised controlled trial (CareHND) at HND-centrum, a novel integrated outpatient clinic in Stockholm.

Our main hypothesis is that HND-centra results in better care, from several aspects, at lower overall burden on the health care system.

The CareHND study will randomise an estimated 260 patients to HND-centrum or standard care.

The sample size is based on a power calculation for the combined outcome (Project 1): readmissions for heart failure, death, myocardial infarction, end-stage renal disease or TIA / stroke with 2 years follow up.

For Project 2, 3 and 4 detailed below the sample size will be 131. At 131 patients randomized an interim analysis will also be performed for the main outcome, after which the sample size will be adjusted if needed.

Inclusion criteria - CareHND:

  1. - Established cardiovascular disease, and:
  2. - Diabetes mellitus type 1 or 2, and:
  3. - Established kidney disease (eGFR <60 mL/min/m2 or macroalbuminuria).

Intervention:

Combined (nurses, physicians and paramedics), integrated (nephrology, diabetology and cardiology), person-centered, intensified chronic disease management at an integrated clinic for up to 12 months.

Outcome measures:

Project 1: traditional outcome measures including disease progression. Project 2: perceived quality of care. Project 3: value-based analysis of integrated clinic and health management. Project 4: Comparison between Sweden and Canada.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. - Established cardiovascular disease (such as history of myocardial infarction, angina, or heart failure requiring hospitalization, previous stroke or TIA with certain diagnosis, and peripheral vascular disease), as well as:
  2. - Diabetes mellitus type 1 or 2 (treated diabetes, or new onset diabetes according to WHO criteria or HbA1C > 48, and symptoms, as well as:
  3. - Established kidney disease (eGFR <60 mL/min/m2 calculated with the CKD-EPI formula, or an average of the CKD -EPI and Cystatin-C eGFR, or borderline GFR but concomitant microalbuminuria, or macroalbuminuria, or kidney transplant).

Exclusion Criteria:

1 - Inability to provide consent

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362983


Contacts
Contact: Jonas Spaak, MD, PhD +46762014178 jonas.spaak@ki.se

Locations
Sweden
HND centrum, Danderyd University Hospital Recruiting
Stockholm, Stockholms LAN, Sweden, 18261
Contact: Jonas Spaak, MD, PhD    +46 76 2014178    jonas.spaak@ki.se   
Sponsors and Collaborators
Danderyd Hospital
Karolinska Institutet
University of British Columbia
Investigators
Principal Investigator: Jonas Spaak, MD, PhD Danderyd University Hospital and Karolinska Institutet
  Study Documents (Full-Text)

Documents provided by Jonas Spaak, Danderyd Hospital:
Study Protocol  [PDF] November 29, 2017

  More Information

Responsible Party: Jonas Spaak, Professor, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT03362983     History of Changes
Other Study ID Numbers: CareHND
First Submitted: June 14, 2017
First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon individual application and review as required by Swedish law.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Chronic Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Disease Attributes
Pathologic Processes