NCT02768480

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

3.5 years

First QC Date

April 29, 2016

Last Update Submit

February 25, 2019

Conditions

Diabetes Mellitus

Keywords

Diabetesphone callsglycemic control

Outcome Measures

Primary Outcomes (1)

  • Glycemic Control

    Evaluation after 1 year of discharge with HbA1c

    1 year

Secondary Outcomes (12)

  • Visits to the doctor, nurse, nutritionist, psychologist

    1 year

  • Rate of referring to tertiary care

    1 year

  • Care satisfaction with diabetes treatment

    1 year

  • Emergency visits because of diabetes acute complications

    1 year

  • Hypoglycaemic rate

    1 year

  • +7 more secondary outcomes

Other Outcomes (1)

  • Blood Pressure

    1 year

Study Arms (2)

Primary Care

ACTIVE COMPARATOR

Patients will be followed by primary care team exclusively.

Other: Primary Care

Phone Calls Support and Primary Care

EXPERIMENTAL

Patients will be followed by primary care team and supported by periodic nurse phone calls.

Other: Phone Calls Support and Primary Care

Interventions

Primary CareOTHER

Patients will be followed by primary care team according to the usual health system routine.

Primary Care
Phone Calls Support and Primary CareOTHER

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.

Phone Calls Support and Primary Care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes;
  • Patients who met discharges criteria according to endocrinology team;
  • Patients with HbA1C \< 8%.

You may not qualify if:

  • Patients with stage IV or V nephropathy;
  • Patients with not controlled Ischemic heart disease;
  • Patients with severe autonomous or peripheral neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (2)

  • Moreira AM, Rados DV, de Farias CB, Coelli S, de Almeida Faller L, Dos Santos LF, Matzenbacher AM, Katz N, Harzeim E, Silveiro SP. Effects of nurse tele support via telephone calls on transition between specialized and primary care in type 2 diabetes mellitus patients: a CONSORT-compliant randomized clinical trial. Endocrine. 2025 Mar;87(3):978-986. doi: 10.1007/s12020-024-04095-6. Epub 2024 Nov 29.

    PMID: 39614069DERIVED

  • 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.

    PMID: 28521796DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Comprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Sandra P Silveiro, MD

    Hospital de Clínicas de Porto Alegre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 11, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)