Chronic Functional ConstipationNCT01901445
Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects
A study testing Educational action with focal group in people with Chronic Functional Constipation, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 19 years
- Conditions the study is for
- Chronic Functional Constipation
- What is being tested?
- Educational action with focal group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children (6 to 9 years-old) and adolescents
- Diagnostic of chronic functional constipation
Who cannot join
- Patients using calcium and/or heme
- Patients with organic diseases that causes constipation
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-901
Gabriela CS Sette, MSc, +55-81-8714-1679, gabrielacssette@gmail.com
Maria Eugenia FA Motta, PhD, +55-81-8868-0555, eugenia.motta@gmail.com
About this study
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.
Read the detailed description
The present research will be conducted on the specific constipation clinic in Hospital das Clínicas at Universidade Federal de Pernambuco.
- Conditions
- Chronic Functional Constipation
- Being tested
- Educational action with focal group
- Keywords
- Quality of life, Constipation, Focus groups, Health education, Problem-based learning
- Medical subject headings
- Constipation, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational action with focal groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Educational action group | Experimental | Not described Receives: Behavioral: Educational action with focal group |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (1)
The improvement in clinical parameters of chronic functional constipation
The clinical parameters were assessed according to a specific questionnaire used on patient assistance at clinical hospital at UFPE. This questionnaire will be applied before and after the intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Cunha Schechtman Sette, Universidade Federal de Pernambuco
- Investigators
- Gabriela CS Sette, MSc, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901445
- Sponsor's protocol ID
- CAAE-0039.0.447.000-11
- Status last verified
- Jul 2013
- First submitted
- 25 May 2013
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects
- ClinicalTrials.gov ID
- NCT01901445
- Acronym / sponsor ID
- CAAE-0039.0.447.000-11
- Conditions
- Chronic Functional Constipation
- Keywords
- Quality of life, Constipation, Focus groups, Health education, Problem-based learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present research will be conducted on the specific constipation clinic in Hospital das Clínicas at Universidade Federal de Pernambuco.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational action group | Experimental | Behavioral: Educational action with focal group |
| Control group | No intervention | – |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children (6 to 9 years-old) and adolescents
- Diagnostic of chronic functional constipation
Key exclusion criteria (2 listed)
- Patients using calcium and/or heme
- Patients with organic diseases that causes constipation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational action with focal group | Behavioural | Educational action group |
Primary outcome
The improvement in the quality of life on participants after the intervention
Time frame: 3 months
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).
1 secondary outcome
The improvement in clinical parameters of chronic functional constipation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela CS Sette, MSc principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational action with focal group in people with Chronic Functional Constipation, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriela CS Sette, MSc (+55-81-8714-1679, gabrielacssette@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement in the quality of life on participants after the intervention (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.