Telephone Use for Care of Persons With Diabetes Mellitus. | NCT01972412

Studies
Telephone Use for Care of Persons With Diabetes Mellitus.

NCT01972412

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Nov 4, 2013Estimated

Enrollment

296Estimated

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

telephone support

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Mar 2014Estimated

First Submitted Date

Mar 26, 2013

First Submission Date that Met QC Criteria

Oct 24, 2013

First Posted Date

Oct 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2013

Last Update Posted Date

Nov 4, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tânia Alves Canata Becker, Telephone Support for self-monitoring of persons with diabetes mellitus, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether phone use contributes to diabetes control.

Detailed Description

Studies reinforce the need to test innovative care that can serve more patients, since education is a key element for the accession to the treatment of diabetes. Recently, an innovative, feasible and low cost presented in the literature is the use of telephone support as an intervention strategy This study aims to evaluate the implementation of a telephone support for self-monitoring of people with diabetes mellitus treated in ribeirão Preto.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

296Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Telephone support	Other	Intervention type: Telephone support for four months.	Behavioral: telephone support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
telephone support	Behavioral	Telephone support for four months about healthy diet, physical activity and medication use.	Telephone support

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Telephone Support for self-monitoring of persons with diabetes mellitus using the Chronic Care Model		Four months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diabetes mellitus type 2
age
ability to listen and answer questions

Exclusion Criteria:

often present less than 75% participation in the proposed activities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tânia A Canata Becker, Master	Contact	551636023434		tania.becker@usp.br

Overall Officials

Name	Affiliation	Role
Tânia A Canata Becker, Master	University of São Paulo at Ribeirão Preto College of Nursing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of São Paulo at Ribeirão Preto College of Nursing	Recruiting	Ribeirão Preto	São Paulo	14040-902	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28793098	Derived	Becker TAC, Teixeira CRS, Zanetti ML, Pace AE, Almeida FA, Torquato MTDCG. Effects of supportive telephone counseling in the metabolic control of elderly people with diabetes mellitus. Rev Bras Enferm. 2017 Jul-Aug;70(4):704-710. doi: 10.1590/0034-7167-2017-0089. English, Portuguese.

Type	Date	Date Unknown
Release	Oct 21, 2014
Reset	Oct 24, 2014
Release	May 13, 2015
Reset	Jun 1, 2015
Release	Oct 6, 2015
Reset	Nov 9, 2015

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 21, 2014			Oct 24, 2014
May 13, 2015

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases