NCT01972412

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
296

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

March 26, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 4, 2013

Status Verified

October 1, 2013

Enrollment Period

9 months

First QC Date

March 26, 2013

Last Update Submit

October 31, 2013

Conditions

Keywords

nursing carediabetes mellitusphone supportchronic care model

Outcome Measures

Primary Outcomes (1)

  • Telephone Support for self-monitoring of persons with diabetes mellitus using the Chronic Care Model

    Four months

Study Arms (1)

Telephone support

OTHER

Intervention type: Telephone support for four months.

Behavioral: telephone support

Interventions

Telephone support for four months about healthy diet, physical activity and medication use.

Telephone support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetes mellitus type 2
  • age
  • ability to listen and answer questions

You may not qualify if:

  • often present less than 75% participation in the proposed activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of São Paulo at Ribeirão Preto College of Nursing

Ribeirão Preto, São Paulo, 14040-902, Brazil

RECRUITING

Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tânia A Canata Becker, Master

    University of São Paulo at Ribeirão Preto College of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tânia A Canata Becker, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Telephone Support for self-monitoring of persons with diabetes mellitus

Study Record Dates

First Submitted

March 26, 2013

First Posted

October 30, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

November 4, 2013

Record last verified: 2013-10

Locations