Clinical trial NCT02768480: Effectiveness of Phone Calls Intervention on Diabetic Patients After Ambulatory Discharge of a Tertiary Care Center
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes
phone calls
glycemic control
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 147
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycemic Control
timeFrame: 1 year
Secondary outcomes:
measure: Visits to the doctor, nurse, nutritionist, psychologist
timeFrame: 1 year
measure: Rate of referring to tertiary care
timeFrame: 1 year
measure: Care satisfaction with diabetes treatment
timeFrame: 1 year
measure: Emergency visits because of diabetes acute complications
timeFrame: 1 year
measure: Hypoglycaemic rate
timeFrame: 1 year
measure: Treatment adherence
timeFrame: 1 year
measure: Lipid control
timeFrame: 1 year
measure: Antiplatelet therapy/ statin use
timeFrame: 1 year
measure: Nephropathy emergence or worsening
timeFrame: 1 year
measure: Retinopathy emergence or worsening
timeFrame: 1 year
measure: Major cardiovascular events
timeFrame: 1 year
measure: Death
timeFrame: 1 year
Other outcomes:
measure: Blood Pressure
timeFrame: 1 year
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Sandra P Silveiro, MD
role: STUDY_DIRECTOR
References:
citation: Moreira AM, Marobin R, Rados DV, de Farias CB, Coelli S, Bernardi BL, Faller LA, Dos Santos LF, Matzenbacher AM, Katz N, Harzheim E, Silveiro SP; TelessaudeRS. Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial. Trials. 2017 May 18;18(1):222. doi: 10.1186/s13063-017-1954-z.