NCT01269086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 27, 2011

Status Verified

October 1, 2010

Enrollment Period

8 months

First QC Date

December 30, 2010

Last Update Submit

May 26, 2011

Conditions

Primary Heath CarePreventive MedicineAdolescent Health ServicesFamilyFamily Practice

Keywords

Primary Heath CarePreventive MedicineAdolescent Health ServicesSpousesFamilyFamily Practice

Outcome Measures

Primary Outcomes (1)

  • Composite outcome: Family Risk Factors

    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 Outcomes (4)

  • Composite outcome: Couple Risk Factors

    1 month

  • Composite outcome: Adolescent Risk Factors

    1 month

  • Type of health plan for follow up

    1 month

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

    1 month

Study Arms (2)

Usual Care

NO INTERVENTION

Traditional care with no systematic assessment of family member´s health problems or risk factors.

Family Preventive Visit

EXPERIMENTAL

Systematic assessment of health diseases or risk factors in the spouse and adolescent child.

Behavioral: Family Preventive Visit

Interventions

Family Preventive VisitBEHAVIORAL

Systematic assessment of health diseases or risk factors in the spouse and adolescent child.

Family Preventive Visit

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of adolescents between 14-17 years.

You may not qualify if:

  • Living with single parents.
  • Does not accept participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Salud Familiar San Alberto Hurtado

Santiago, Chile

Location

Study Officials

  • Diego Garcia-Huidobro, MD

    Family Medicine Department, Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2010

First Posted

January 4, 2011

Study Start

September 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 27, 2011

Record last verified: 2010-10

Locations

CL(1)