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

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
Care satisfaction with diabetes treatment	1 year	Evaluation after 1 year of discharge with a structured questionnaire

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil