Diabetes Mellitus
Conditions
Keywords
Diabetes, phone calls, glycemic control
Brief summary
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).
Detailed description
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.
Interventions
OTHERPrimary Care
Patients will be followed by primary care team according to the usual health system routine.
OTHERPhone Calls Support and Primary Care
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.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes; * Patients who met discharges criteria according to endocrinology team; * Patients with HbA1C \< 8%.
Exclusion criteria
* Patients with stage IV or V nephropathy; * Patients with not controlled Ischemic heart disease; * Patients with severe autonomous or peripheral neuropathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control | 1 year | Evaluation after 1 year of discharge with HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visits to the doctor, nurse, nutritionist, psychologist | 1 year | Evaluation after 1 year of discharge with a structured questionnaire |
| Rate of referring to tertiary care | 1 year | Evaluation after 1 year of discharge with a structured questionnaire |
| Care satisfaction with diabetes treatment | 1 year | Evaluation after 1 year of discharge with a structured questionnaire |
| Emergency visits because of diabetes acute complications | 1 year | Evaluation after 1 year of discharge with a structured questionnaire |
| Hypoglycaemic rate | 1 year | Evaluation after 1 year of discharge with a structured questionnaire |
| Treatment adherence | 1 year | Evaluation after 1 year of discharge with the Brief Medication Questionnaire |
| Antiplatelet therapy/ statin use | 1 year | Evaluation after 1 year of discharge with a structured questionnaire |
| Nephropathy emergence or worsening | 1 year | Evaluation after 1 year of discharge with microalbuminuria and blood creatinine measurement |
| Retinopathy emergence or worsening | 1 year | Evaluation after 1 year of discharge with retinography and ophthalmologist advice if is necessary. |
| Major cardiovascular events | 1 year | Evaluation after 1 year of discharge with a structured questionnaire |
| Death | 1 year | Evaluation after 1 year of discharge with telephone contact and active search |
| Lipid control | 1 year | Evaluation after 1 year of discharge with blood lipid levels |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 1 year | Evaluation after 1 year of discharge with blood pressure measurement |
Countries
Brazil
Outcome results
None listed