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

NCT03362983 | Completed

• 1 other identifier: CareHND
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Chronic Kidney Diseases; Cardiovascular Diseases; Chronic Disease; Multimorbidity

Outcome Measures

Primary Outcomes (3)

• Disease progression (n=260)

  Combined death or readmission due to heart failure, myocardial infarction, PCI/CABG, end stage renal failure, acute renal failure or TIA / stroke.

  2 years

• Patient centered outcome measures (n=131)

  Perceived quality of care and patient empowerment assessed by a PROMs (Patient Reported Outcome Measure) questionaire with a sum score.

  1 year

• Quality-of-care outcome measures (n=131)

  Combined score of achieved target blood pressure, target HbA1C and target LDL.

  1 year

Secondary Outcomes (5)

• Organ damage (n=131)

  1 year

• System biology (n=131)

  1 year

• Health care structure and utilization (n=131)

  1 year.

• Patient safety (n=131)

  1 year

• Interdisciplinary learning (n=20)

  1 year

Study Arms (2)

Care HND Intervention

EXPERIMENTAL

Integrated, multidisciplinary, person centered care at HND-centrum.

Other: CareHND

Standard care

NO INTERVENTION

Standard care at separate specialty clinics and primary care as needed.

Interventions

CareHND OTHER

Multidisciplinary, integrated, person-centered care at the integrated HND-clinic

Care HND Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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:
• \- Diabetes mellitus type 1 or 2 (treated diabetes, or new onset diabetes according to WHO criteria or HbA1C \> 48, and symptoms, as well as:
• \- 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).

You may not qualify if:

• Inability to provide consent

Sponsors & Collaborators

• Danderyd Hospital: lead
• Karolinska Institutet: collaborator
• University of British Columbia: collaborator

Study Sites (1)

HND centrum, Danderyd University Hospital

Stockholm, Stockholm County, 18261, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic; Cardiovascular Diseases; Chronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonas Spaak, MD, PhD

  Danderyd University Hospital and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: December 5, 2017
• Study Start: January 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: November 30, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)