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

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Primary Care; Other: Phone Calls Support and Primary Care

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 Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Primary Care; Patients will be followed by primary care team exclusively.	Other: Primary Care; Patients will be followed by primary care team according to the usual health system routine.
EXPERIMENTAL: Phone Calls Support and Primary Care; Patients will be followed by primary care team and supported by periodic nurse phone calls.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control	Evaluation after 1 year of discharge with HbA1c	1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Evaluation after 1 year of discharge with blood pressure measurement	1 year

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Study Director: Sandra P Silveiro, MD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (ESTIMATE): May 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; glycemic control; phone calls
• Other Study ID Numbers: 150503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO