NCT01901445

Brief Summary

The purpose of this study is to determine if the quality of life in children and adolescents diagnosed with chronic functional constipation improves after educational activity in focus group composed by these patients' mothers.

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
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 17, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

May 25, 2013

Last Update Submit

July 13, 2013

Conditions

Chronic Functional Constipation

Keywords

Quality of lifeConstipationFocus groupsHealth educationProblem-based learning

Outcome Measures

Primary Outcomes (1)

  • The improvement in the quality of life on participants after the intervention

    The quality of life outcomes will be assessed by using the Generic Core Questionnaires (Standard form) of Measurement Model for the Pediatric Quality of Life InventoryTM version (PedsQL) 4.0 Generic Core Scales (VARNI et al., 2001) was translated and validated in Brazil by Klatchoian et al. (2008).

    3 months

Secondary Outcomes (1)

  • The improvement in clinical parameters of chronic functional constipation

    3 months

Study Arms (2)

Educational action group

EXPERIMENTAL
Behavioral: Educational action with focal group

Control group

NO INTERVENTION

Interventions

Educational action with focal groupBEHAVIORAL
Educational action group

Eligibility Criteria

Age6 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children (6 to 9 years-old) and adolescents
  • Diagnostic of chronic functional constipation

You may not qualify if:

  • Patients using calcium and/or heme
  • Patients with organic diseases that causes constipation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

MeSH Terms

Conditions

ConstipationHealth Education

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Gabriela CS Sette, MSc

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela CS Sette, MSc

CONTACT

+55-81-8714-1679gabrielacssette@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

May 25, 2013

First Posted

July 17, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

July 17, 2013

Record last verified: 2013-07

Locations

BR(1)