Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03362983 |
| Other study ID # |
CareHND |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2016 |
| Est. completion date |
November 30, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Danderyd Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
