Primary Heath CareNCT01269086
Family Preventive Visits to Detect Risk Factors in the Family
A study testing Family Preventive Visit in people with Primary Heath Care and Preventive Medicine, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Primary Heath Care, Preventive Medicine, Adolescent Health Services
- What is being tested?
- Family Preventive Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChile
- Study dates
- Sep 2010to May 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents of adolescents between 14-17 years.
Who cannot join
- Living with single parents.
- Does not accept participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Primary Heath Care, Preventive Medicine, Adolescent Health Services, Family, Family Practice
- Being tested
- Family Preventive Visit
- Keywords
- Primary Heath Care, Preventive Medicine, Adolescent Health Services, Spouses, Family, Family Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Preventive VisitBehavioural
Systematic assessment of health diseases or risk factors in the spouse and adolescent child.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family Preventive Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (4)
Composite outcome: Couple 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 presence of marital relationship problems detected by the spouse.
Measured: 1 month
Composite outcome: Adolescent Risk Factors
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.
Measured: 1 month
Type of health plan for follow up
The health plan will be categorized in comprehensive bio-psycho-social health plans or only biomedical health plans.
Measured: 1 month
Diagnostic accuracy of adults to diagnose risk factors in their spouse or adolescent child.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Heath CareStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Hispanoamericana de Solidaridad, Fundacion MAPFRE
- Investigators
- Diego Garcia-Huidobro, MD, Principal investigator, Family Medicine Department, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269086
- Sponsor's protocol ID
- 00001
- Status last verified
- Oct 2010
- First submitted
- 30 Dec 2010
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Preventive Visits to Detect Risk Factors in the Family
- ClinicalTrials.gov ID
- NCT01269086
- Acronym / sponsor ID
- 00001
- Conditions
- Primary Heath Care, Preventive Medicine, Adolescent Health Services, Family, Family Practice
- Keywords
- Primary Heath Care, Preventive Medicine, Adolescent Health Services, Spouses, Family, Family Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Fundacion Hispanoamericana de Solidaridad, Fundacion MAPFRE
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Jan 2011 (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 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Traditional care with no systematic assessment of family member´s health problems or risk factors. |
| Family Preventive Visit | Experimental | Behavioral: Family Preventive VisitSystematic assessment of health diseases or risk factors in the spouse and adolescent child. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of adolescents between 14-17 years.
Key exclusion criteria (2 listed)
- Living with single parents.
- Does not accept participating in the study.
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 |
|---|---|---|
| Family Preventive VisitSystematic assessment of health diseases or risk factors in the spouse and adolescent child. | Behavioural | Family Preventive Visit |
Primary outcome
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.
4 secondary outcomes
Composite outcome: Couple Risk Factors
Time frame: 1 month
Composite outcome: Adolescent Risk Factors
Time frame: 1 month
Type of health plan for follow up
Time frame: 1 month
Diagnostic accuracy of adults to diagnose risk factors in their spouse or adolescent child.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
Related trials for Primary Heath Care
Not yet recruitingObservational study
Exploration of Acceptability of Alcohol Interventions
Alcohol Misuse, Alcohol Use Disorder
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.
Diego Garcia-Huidobro, MD principal investigator
Family Medicine Department, Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Preventive Visit in people with Primary Heath Care and Preventive Medicine, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 1 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: finished, as of the sponsor's last update on 27 May 2011. 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 Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome: Family Risk Factors (time frame: 1 month). 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 27 May 2011.