Computer-assisted Psychosocial Risk Assessment (CaPRA) for Refugee Health and Settlement (CaPRA)

September 1, 2011 updated by: University of Toronto

Computer-assisted Psychosocial Risk Assessment (CaPRA) for Refugee Health and Settlement - Evaluation Phase

The purpose of this study was to examine preliminary effect of Computer-assisted Psychosocial Risk Assessment tool (CaPRA) among Afghan refugees visiting medical professionals (family physicians or nurse practitioners) at a Community Health Center. The investigators examined the tool's acceptability among patients and its impact on patient satisfaction and patient intention to visit a psychosocial counselor as a proxy of potential to integrate medical and social care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The recent waves of refugees to Canada belong to regions of prolonged conflict and, thus arrive in compromised state of mental, physical, and social health. This complexity asks for provision of integrated medical and social care to newly arrived refugees. With this aim, a university-community initiative developed a Computer-assisted Psychosocial Risk Assessment tool (CaPRA) in Dari/Farsi for Afghan refugees. This innovative eHealth approach is first of its kind for Canadian refugees accessing primary care. In this model of care, patients complete an interactive multi-risk iPad computer survey in their own language before seeing the provider. The computer then generates individualized recommendation sheet for patients and a risk-report for providers at the point of care. The tool was developed through a collaborative process by working with Access Alliance Multicultural Health and Community Services and advisory board with community representatives.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Afghan refugee patients
  • Over 18 years of age
  • Speak and read Dari /Farsi or English language
  • Eligible for federal or provincial health care program
  • Visiting a participating medical practitioner

Exclusion Criteria:

  • Patient visiting a provider who has not consented for the study
  • Patient accompanied by a family member for interpretation
  • New patients
  • Patients unable to receive study details due to logistical issue (e.g, no private room)

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention (CaPRA)
Behavioral: Computer-assisted Psychosocial Risk Assessment (CaPRA)
The study intervention was a touch-screen self-assessment survey which eligible patients completed on a touch-screen iPad in Dari/Farsi language while waiting to see their medical practitioner. The Computer-assisted Psychosocial Risk Assessment (CaPRA) survey had questions on psychosocial risks (e.g., alcohol, tobacco and street drug use, sexual health, personal violence, post-traumatic stress disorder, depression, and food insecurity), cardiovascular risks (e.g., physical activity, weight, diabetes, and hypertension), road and home safety, stress buffers (e.g., coping and social support) and sociodemographics. The tool generated two tailored print-outs at the point of care. The recommendation sheet for patients summarized their disclosed risks in simple Dari/Farsi language along with contacts of relevant services. The risk-report for medical practitioner summarized patients' risks with possible referrals. This was attached to the medical chart prior to the consult.
NO_INTERVENTION: Control (usual care)
Behavioral: Computer-assisted Psychosocial Risk Assessment (CaPRA)
The study intervention was a touch-screen self-assessment survey which eligible patients completed on a touch-screen iPad in Dari/Farsi language while waiting to see their medical practitioner. The Computer-assisted Psychosocial Risk Assessment (CaPRA) survey had questions on psychosocial risks (e.g., alcohol, tobacco and street drug use, sexual health, personal violence, post-traumatic stress disorder, depression, and food insecurity), cardiovascular risks (e.g., physical activity, weight, diabetes, and hypertension), road and home safety, stress buffers (e.g., coping and social support) and sociodemographics. The tool generated two tailored print-outs at the point of care. The recommendation sheet for patients summarized their disclosed risks in simple Dari/Farsi language along with contacts of relevant services. The risk-report for medical practitioner summarized patients' risks with possible referrals. This was attached to the medical chart prior to the consult.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient intention to visit a psychosocial counselor
Time Frame: July to October post-visit
Patients completed a paper-pencil Exit Survey in the intervention (CaPRA) and control (usual care) groups
July to October post-visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: July to October post-visit
Patients completed a paper-pencil Exit Survey in the intervention (CaPRA) and control (usual care) groups
July to October post-visit
Patient acceptability
Time Frame: July to October post-visit
Patients completed a paper-pencil Exit Survey in the intervention group (CaPRA)
July to October post-visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Farah Ahmad, MBBS, MPH, PhD, University of Toronto / York University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FA-25340

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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