Family Preventive Visits to Detect Risk Factors in the Family

• Sponsor: Pontificia Universidad Catolica de Chile (Other)
• Overall Status: Completed
• CT.gov ID: NCT01269086
• Collaborator: Fundacion Hispanoamericana de Solidaridad (Other), Fundacion MAPFRE (Other)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 37.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Primary Heath Care; Preventive Medicine; Adolescent Health Services; Family; Family Practice	Behavioral: Family Preventive Visit	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Family Preventive Visits to Detect Risk Factors in the Family
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

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.	Behavioral: Family Preventive Visit; Systematic assessment of health diseases or risk factors in the spouse and adolescent child.

Outcome Measures

Primary Outcome Measures

1. Composite outcome: Family Risk Factors [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.

Secondary Outcome Measures

1. Composite outcome: Couple Risk Factors [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.

2. Composite outcome: Adolescent Risk Factors [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.

3. Type of health plan for follow up [1 month]

   The health plan will be categorized in comprehensive bio-psycho-social health plans or only biomedical health plans.

4. Diagnostic accuracy of adults to diagnose risk factors in their spouse or adolescent child. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01269086
• Other Study ID Numbers: 00001
• First Posted: Jan 4, 2011
• Last Update Posted: May 27, 2011
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: Primary Heath Care; Preventive Medicine; Adolescent Health Services; Spouses; Family; Family Practice

Study Results

No Results Posted as of May 27, 2011