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The study is a randomized clinical trial, controlled, open label that aimed to compare two groups after discharge of a tertiary care: type 2 diabetes patients followed exclusively by primary care (control group) and patients followed by primary care and supported by phone calls (intervention group).
The investigators designed a randomized controlled trial. Patients with stable and controlled type 2 diabetes, and considered to be eligible to discharge from specialized care to primary care will be included. Patients with severe neuropathy, not controlled ischemic heart disease and nephropathy stage IV/V will be excluded. Enrolled patients will be randomized in two groups: follow-up supported by periodic nurse phone calls plus primary care (intervention group) or followed by primary care team (control group). The intervention group will receive regular telephone calls (every 3 months for 1 year) and will have a toll-free number to resolve questions about the disease management. Main outcome is the glycemic control between groups after 1 year of follow-up. Secondary outcomes include: rate of hypoglycaemia, blood pressure control,emergency visits, nephropathy progression and death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Care | Active Comparator | Patients will be followed by primary care team exclusively. |
|
| Phone Calls Support and Primary Care | Experimental | Patients will be followed by primary care team and supported by periodic nurse phone calls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Care | Other | Patients will be followed by primary care team according to the usual health system routine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | Evaluation after 1 year of discharge with HbA1c | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Visits to the doctor, nurse, nutritionist, psychologist | Evaluation after 1 year of discharge with a structured questionnaire | 1 year |
| Rate of referring to tertiary care | Evaluation after 1 year of discharge with a structured questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Evaluation after 1 year of discharge with blood pressure measurement | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra P Silveiro, MD | Hospital de ClÃnicas de Porto Alegre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39614069 | Derived | Moreira AM, Rados DV, de Farias CB, Coelli S, de Almeida Faller L, Dos Santos LF, Matzenbacher AM, Katz N, Harzeim E, Silveiro SP. Effects of nurse tele support via telephone calls on transition between specialized and primary care in type 2 diabetes mellitus patients: a CONSORT-compliant randomized clinical trial. Endocrine. 2025 Mar;87(3):978-986. doi: 10.1007/s12020-024-04095-6. Epub 2024 Nov 29. | |
| 28521796 |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D011320 | Primary Health Care |
| ID | Term |
|---|---|
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Phone Calls Support and Primary Care | Other | Patients in intervention group will receive periodic phone calls (every three months) and will have a toll-free number to resolve questions about the disease management. The phone-calls will be performed by trained nurses and will follow a structured format. Nurses will address some topics: patient's treatment adherence, technique of insulin administration, disease understanding, hypoglycaemia management, healthy diet, smoke cessation and foot care. |
|
| 1 year |
| Care satisfaction with diabetes treatment | Evaluation after 1 year of discharge with a structured questionnaire | 1 year |
| Emergency visits because of diabetes acute complications | Evaluation after 1 year of discharge with a structured questionnaire | 1 year |
| Hypoglycaemic rate | Evaluation after 1 year of discharge with a structured questionnaire | 1 year |
| Treatment adherence | Evaluation after 1 year of discharge with the Brief Medication Questionnaire | 1 year |
| Lipid control | Evaluation after 1 year of discharge with blood lipid levels | 1 year |
| Antiplatelet therapy/ statin use | Evaluation after 1 year of discharge with a structured questionnaire | 1 year |
| Nephropathy emergence or worsening | Evaluation after 1 year of discharge with microalbuminuria and blood creatinine measurement | 1 year |
| Retinopathy emergence or worsening | Evaluation after 1 year of discharge with retinography and ophthalmologist advice if is necessary. | 1 year |
| Major cardiovascular events | Evaluation after 1 year of discharge with a structured questionnaire | 1 year |
| Death | Evaluation after 1 year of discharge with telephone contact and active search | 1 year |
| Derived |
| Moreira AM, Marobin R, Rados DV, de Farias CB, Coelli S, Bernardi BL, Faller LA, Dos Santos LF, Matzenbacher AM, Katz N, Harzheim E, Silveiro SP; TelessaudeRS. Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial. Trials. 2017 May 18;18(1):222. doi: 10.1186/s13063-017-1954-z. |