An interventional study of CareHND in Diabetes Mellitus, Chronic Kidney Diseases and Cardiovascular Diseases, sponsored by Danderyd Hospital. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2021-01-13.
Sponsored by Danderyd Hospital · Not applicable, Interventional, and Treatment
Among 168 studies in Diabetes Mellitus with a site in Sweden — 16 open to participants now, 19 under way, 1 of them phase 3. Diabetes Mellitus · Sweden.
Among the 168 studies in Diabetes Mellitus with a site in Sweden, this one is the 72nd largest by enrollment of the 132 interventional ones that give a count, is one of 7 that started in 2016, is one of 33 with no phase, and was the 130th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
Browse Diabetes Mellitus studies →16 of the 168 studies in Diabetes Mellitus with a site in Sweden are open now. Recruiting first, the newest first:
Aventyn, Inc. · Sites in Sweden, United States
Ages 18+
Vastra Gotaland Region · Sites in Sweden
Ages 18+
Johan Sundström · Sites in Sweden
Ages 50–75 · Healthy volunteers
Malmö University · Sites in Sweden
Ages 18+
Technical University of Munich · Sites in Sweden, Austria, Belgium and 2 more countries
Ages 3 mo–4 mo · Healthy volunteers
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
168 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 27 · Phase 3 46 · Phase 4 21
First in 1989; this study’s year is marked. 7 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 131 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Median enrollment 165 across the 132 interventional studies, 500 across the 35 observational. Of the 127 that completed or were terminated, 40 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
97 of 168 have an industry lead sponsor. The 10 most frequent:
Danderyd Hospital is the lead sponsor of 60 studies on the registry; 13 are open to participants now.
Danderyd Hospital has 2 studies filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
4 of the studies in Diabetes Mellitus with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05810311Region StockholmThe Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy | 2027-01-01 |
| NCT07426224Folktandvården Stockholms län ABBlood Glucose Screening in Patients With Advanced Periodontits: the Role of Specialist Periodontal Care in Identifying Hyperglycaemia and Supporting Patient Centered Treatment | 2027-03-01 |
| NCT05317130Lund UniversityA Complex Health Promotion Intervention in Parasport - The Safe & Healthy Parasport Project | 2027-09-01 |
| NCT06452654Technical University of MunichAnti-viral Action Against Type 1 Diabetes Autoimmunity | 2027-10 |
Add all 4 to your calendar (.ics) → With an account.
Among the 168 studies in Diabetes Mellitus with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1 - Inability to provide consent
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Integrated, multidisciplinary, person centered care at HND-centrum.
Other: CareHND
Standard care at separate specialty clinics and primary care as needed.
Multidisciplinary, integrated, person-centered care at the integrated HND-clinic
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.
Time frame: 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.
Time frame: 1 year
Quality-of-care outcome measures (n=131)
Combined score of achieved target blood pressure, target HbA1C and target LDL.
Time frame: 1 year
Organ damage (n=131)
Decline in eGFR
Time frame: 1 year
System biology (n=131)
Changes in markers of disease progression in transcriptomics, proteomics and metabolomics.
Time frame: 1 year
Health care structure and utilization (n=131)
Health care utilization measured by number of outpatient and inpatient contacts
Time frame: 1 year.
Patient safety (n=131)
Using logged patient safety reports.
Time frame: 1 year
Interdisciplinary learning (n=20)
Qualitative analysis of interdisciplinary learning between personnel.
Time frame: 1 year
Plan to share: Yes — Upon individual application and review as required by Swedish law.
Ran from Jan 2016 to primary completion in Dec 2019, 47 months.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 47 months is above that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Danderyd Hospital