Effectiveness of Phone Calls Intervention on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center
- Conditions
- Diabetes Mellitus
- Interventions
- Other: Phone Calls Support and Primary CareOther: Primary Care
- Registration Number
- NCT02768480
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
- Patients with type 2 diabetes;
- Patients who met discharges criteria according to endocrinology team;
- Patients with HbA1C < 8%.
- Patients with stage IV or V nephropathy;
- Patients with not controlled Ischemic heart disease;
- Patients with severe autonomous or peripheral neuropathy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phone Calls Support and Primary Care Phone Calls Support and Primary Care Patients will be followed by primary care team and supported by periodic nurse phone calls. Primary Care Primary Care Patients will be followed by primary care team exclusively.
- Primary Outcome Measures
Name Time Method Glycemic Control 1 year Evaluation after 1 year of discharge with HbA1c
- Secondary Outcome Measures
Name Time Method Visits to the doctor, nurse, nutritionist, psychologist 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
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
Antiplatelet therapy/ statin use 1 year Evaluation after 1 year of discharge with a structured questionnaire
Major cardiovascular events 1 year Evaluation after 1 year of discharge with a structured questionnaire
Retinopathy emergence or worsening 1 year Evaluation after 1 year of discharge with retinography and ophthalmologist advice if is necessary.
Rate of referring to tertiary care 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
Lipid control 1 year Evaluation after 1 year of discharge with blood lipid levels
Nephropathy emergence or worsening 1 year Evaluation after 1 year of discharge with microalbuminuria and blood creatinine measurement
Trial Locations
- Locations (1)
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil