Family Preventive Visits to Detect Risk Factors in the Family

This study has been completed.
Sponsor:
Collaborators:
Fundacion Hispanoamericana de Solidaridad
Fundacion MAPFRE
Information provided by:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01269086
First received: December 30, 2010
Last updated: May 26, 2011
Last verified: October 2010
  Purpose

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.


Condition Intervention
Primary Heath Care
Preventive Medicine
Adolescent Health Services
Family
Family Practice
Behavioral: Family Preventive Visit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Family Preventive Visits to Detect Risk Factors in the Family

Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • Composite outcome: Family Risk Factors [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Composite outcome: Couple Risk Factors [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.

  • Composite outcome: Adolescent Risk Factors [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.

  • Type of health plan for follow up [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The health plan will be categorized in comprehensive bio-psycho-social health plans or only biomedical health plans.

  • Diagnostic accuracy of adults to diagnose risk factors in their spouse or adolescent child. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Family Preventive Visit
Systematic assessment of health diseases or risk factors in the spouse and adolescent child.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parents of adolescents between 14-17 years.

Exclusion Criteria:

  • Living with single parents.
  • Does not accept participating in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269086

Locations
Chile
Centro de Salud Familiar San Alberto Hurtado
Santiago, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Fundacion Hispanoamericana de Solidaridad
Fundacion MAPFRE
Investigators
Principal Investigator: Diego Garcia-Huidobro, MD Family Medicine Department, Pontificia Universidad Catolica de Chile
  More Information

No publications provided

Responsible Party: Diego Garcia-Huidobro, Family Medicine Department, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01269086     History of Changes
Other Study ID Numbers: 00001
Study First Received: December 30, 2010
Last Updated: May 26, 2011
Health Authority: Chile: Pontificia Universidad Catolica de Chile School of Medicine

Keywords provided by Pontificia Universidad Catolica de Chile:
Primary Heath Care
Preventive Medicine
Adolescent Health Services
Spouses
Family
Family Practice

ClinicalTrials.gov processed this record on July 31, 2014