Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
NCT Number: NCT02768480
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).
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Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be followed by primary care team according to the usual health system routine.
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.
Time frame: 1 year
Evaluation after 1 year of discharge with HbA1c
Time frame: 1 year
Evaluation after 1 year of discharge with a structured questionnaire
Time frame: 1 year
Evaluation after 1 year of discharge with a structured questionnaire
Time frame: 1 year
Evaluation after 1 year of discharge with a structured questionnaire
Time frame: 1 year
Evaluation after 1 year of discharge with a structured questionnaire
Time frame: 1 year
Evaluation after 1 year of discharge with a structured questionnaire
Time frame: 1 year
Evaluation after 1 year of discharge with the Brief Medication Questionnaire
Time frame: 1 year
Evaluation after 1 year of discharge with blood lipid levels
Time frame: 1 year
Evaluation after 1 year of discharge with a structured questionnaire
Time frame: 1 year
Evaluation after 1 year of discharge with microalbuminuria and blood creatinine measurement
Time frame: 1 year
Evaluation after 1 year of discharge with retinography and ophthalmologist advice if is necessary.
Time frame: 1 year
Evaluation after 1 year of discharge with a structured questionnaire
Time frame: 1 year
Evaluation after 1 year of discharge with telephone contact and active search
Time frame: 1 year
Evaluation after 1 year of discharge with blood pressure measurement
Hospital de Clinicas de Porto Alegre
Other
Evaluation of the Effectiveness of Phone Calls Intervention (TelessaúdeRS) on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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