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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768480
• Other study ID #: 150503
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Primary Care
Patients will be followed by primary care team according to the usual health system routine.
• Phone 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Pressure	Evaluation after 1 year of discharge with blood pressure measurement	1 year
Primary	Glycemic Control	Evaluation after 1 year of discharge with HbA1c	1 year
Secondary	Visits to the doctor, nurse, nutritionist, psychologist	Evaluation after 1 year of discharge with a structured questionnaire	1 year
Secondary	Rate of referring to tertiary care	Evaluation after 1 year of discharge with a structured questionnaire	1 year
Secondary	Care satisfaction with diabetes treatment	Evaluation after 1 year of discharge with a structured questionnaire	1 year
Secondary	Emergency visits because of diabetes acute complications	Evaluation after 1 year of discharge with a structured questionnaire	1 year
Secondary	Hypoglycaemic rate	Evaluation after 1 year of discharge with a structured questionnaire	1 year
Secondary	Treatment adherence	Evaluation after 1 year of discharge with the Brief Medication Questionnaire	1 year
Secondary	Lipid control	Evaluation after 1 year of discharge with blood lipid levels	1 year
Secondary	Antiplatelet therapy/ statin use	Evaluation after 1 year of discharge with a structured questionnaire	1 year
Secondary	Nephropathy emergence or worsening	Evaluation after 1 year of discharge with microalbuminuria and blood creatinine measurement	1 year
Secondary	Retinopathy emergence or worsening	Evaluation after 1 year of discharge with retinography and ophthalmologist advice if is necessary.	1 year
Secondary	Major cardiovascular events	Evaluation after 1 year of discharge with a structured questionnaire	1 year
Secondary	Death	Evaluation after 1 year of discharge with telephone contact and active search	1 year