- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01269086
Family Preventive Visits to Detect Risk Factors in the Family
May 26, 2011 updated by: Pontificia Universidad Catolica de Chile
The purpose of this study is to determine whether a systematic family assessment in adult preventive health visits increases the detection of risk factors in the spouse or adolescent child of the screened person.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Santiago, Chile
- Centro de Salud Familiar San Alberto Hurtado
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parents of adolescents between 14-17 years.
Exclusion Criteria:
- Living with single parents.
- Does not accept participating in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
Traditional care with no systematic assessment of family member´s health problems or risk factors.
|
|
Experimental: Family Preventive Visit
Systematic assessment of health diseases or risk factors in the spouse and adolescent child.
|
Systematic assessment of health diseases or risk factors in the spouse and adolescent child.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite outcome: Family Risk Factors
Time Frame: 1 month
|
The composite outcome is conformed by: detection of smoking, alcohol, substance abuse, major depression or other mental health disease, high emotional stress, suicide risk in the couple and the adolescent child; and risk of pregnancy, risk of sexually transmitted diseases, risk of eating disorders, risk of school grade repetition or school drop-out in the adolescent child, and the presence of marital or parent-child relationship problems detected by the parent/spouse.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite outcome: Couple Risk Factors
Time Frame: 1 month
|
The composite outcome is conformed by: detection of smoking, alcohol, substance abuse, major depression or other mental health disease, high emotional stress, suicide risk in the couple, and the presence of marital relationship problems detected by the spouse.
|
1 month
|
Composite outcome: Adolescent Risk Factors
Time Frame: 1 month
|
The composite outcome is conformed by: smoking, alcohol, substance abuse, major depression or other mental health disease, high emotional stress, risk of suicide, risk of pregnancy, risk of sexually transmitted diseases, risk of eating disorders, risk of school grade repetition or school drop-out in the adolescent child, and the presence of parent-child relationship problems detected by the parent.
|
1 month
|
Type of health plan for follow up
Time Frame: 1 month
|
The health plan will be categorized in comprehensive bio-psycho-social health plans or only biomedical health plans.
|
1 month
|
Diagnostic accuracy of adults to diagnose risk factors in their spouse or adolescent child.
Time Frame: 1 month
|
We will assess sensibility, specificity, positive and negative predictive values, positive and negative likelihood ratios of parents to detect risk factors in their spouse and child.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Diego Garcia-Huidobro, MD, Family Medicine Department, Pontificia Universidad Catolica de Chile
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
December 30, 2010
First Submitted That Met QC Criteria
January 3, 2011
First Posted (Estimate)
January 4, 2011
Study Record Updates
Last Update Posted (Estimate)
May 27, 2011
Last Update Submitted That Met QC Criteria
May 26, 2011
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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