Effectiveness of Phone Calls Intervention on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Evaluation of the Effectiveness of Phone Calls Intervention (TelessaúdeRS) on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center: A Randomized Clinical Trial

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Primary Care
* Other: Phone Calls Support and Primary Care


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primary Care<br>Patients will be followed by primary care team exclusively. | Other: Primary Care<br>* Patients will be followed by primary care team according to the usual health system routine.<br>|
| Experimental: Phone Calls Support and Primary Care<br>Patients will be followed by primary care team and supported by periodic nurse phone calls. | Other: Phone Calls Support and Primary Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control | Evaluation after 1 year of discharge with HbA1c | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, phone calls, glycemic control