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Controlling secondary hyperparathyroidism (sHPT) in maintenance hemodialysis (MHD) patients is cumbersome, partly due to patient's non-adherence to prescribed drugs.
The main objective of this study was to assess whether an integrated care (IC) approach, in which adherence data are integrated in the decisional process, led to improved therapeutic control of secondary hyperparathyroidsm and higher percentages of bone metabolism targets as compared to a usual care (UC) approach, in which biological values represent the main stem of the decisional process.
The predefined hypothesis was that patients of the IC group should reach the iPTH targets using 25% less doses of cinacalcet at 6 months than those of the UC group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual care | No Intervention | ||
| adherence intervention arm | Active Comparator | Monitoring drug adherence to guide treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring of drug adherence | Other | In the IC group, biological and drug adherence results are shown and discussed through a nephrologists leaded semi-structured motivation interviews at interval of 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in cinacalcet dose at 6 months |
| baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| absolute change from baseline in iPTH at 6 months |
| baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Burnier, MD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D051436 | Renal Insufficiency, Chronic |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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|
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |