AsthmaNCT01474928
Asthma and Health Literacy in Newcomer Communities in the Greater Vancouver Area
A study testing patient role played community video, both videos group and Pamphlet group in people with Asthma, run by University of British Columbia at 2 sites in Canada.
Trial summary
In this study, the investigators aim to develop and test the effectiveness of culturally appropriate asthma videos and other educational materials based on knowledge from this study and the investigators' previous studies. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Asthma
- What is being tested?
- patient role played community video, both videos group and Pamphlet group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2009to Jul 2014
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosed mild to moderate asthma according to CTS criteria
- Asthmatics from Chinese and Punjabi communities in the Greater Vancouver Area (GVA), BC
- Age greater than 21 years
- Immigrated to Canada in the last 10 yrs
- Patients who are able to give informed consent and are willing to participate in the study
Who cannot join
- Age less than 21 years
- Other immigrants than Punjabi and Chinese
- Immigrated before 1998
- Patients who do not want to sign the consent form
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Asthma and Health Literacy in Newcomer Communities in the Greater Vancouver Area (GVA): A Population-based Qualitative Study
In this study, the investigators aim to develop and test the effectiveness of culturally appropriate asthma videos and other educational materials based on knowledge from this study and the investigators' previous studies. By culturally appropriate materials the investigators mean to develop health information (in the format of video and written materials) in the community own language and applied the most appealing cultural beliefs and practices in the Chinese and Punjabi communities. The investigators also aim to recommend a practical framework and to develop a measure of asthma knowledge and health literacy among immigrants from the Punjabi and Chinese communities in BC. The investigators' definition of health literacy in this study is the capability of a person to navigate and access to asthma-related information, as well as to understand, evaluate, and communicate the obtained information to improve his/her health status. The investigators' hypothesis is that audio-visual based asthma information in a subject's native language would improve a patient's knowledge and self-management of asthma in comparison to printed information.
Read the detailed description
There is compelling evidence indicating that newcomers to Canada with limited English proficiency and low health literacy are facing systemic, linguistic and cultural barriers in accessing health information and treatment services pertaining to Asthma. The intent of this study is to develop and test the effectiveness of culturally appropriate asthma videos and other educational materials based on knowledge from this study and the investigators' previous elicitation studies, to recommend a practical framework and to develop a measure of asthma knowledge and health literacy among immigrants from the Punjabi and Chinese communities in the Greater Vancouver Area.
The objectives of the proposed research are: "1." to assess the knowledge, attitudes, beliefs, and practices related to asthma and relevant issues in selected individuals within the target communities; "2." to investigate access and utilization patterns of asthma-related services among participant communities; "3." to assess the effectiveness of culturally competent and participatory developed videos and written educational materials on individuals' knowledge and health literacy skills related to asthma; "4." to examine relationships between health literacy, culture, language and access to and utilization of asthma services among targeted newcomer individuals; "5." to build research capacity and community-university-service provider alliances, and contribute to the development of an integrated research-service agenda on newcomers' asthma self-management among target communities; and "6." to disseminate information to decision makers and knowledge-users , so the results of this study can be efficiently used in developing relevant services that meet newcomers' needs. The proposed research will use quantitative and qualitative methods including a full participatory approach that builds on the investigators' previous work with vulnerable ethno-cultural communities in BC.
The implementation of the project will include the following phases:
"1." Conduct environmental scan and needs assessment study (literature review and interviews); "2" Develop video clips, written materials, and relevant measurement tools; "3" Apply the video clips and written materials to test their effectiveness among individuals from the target communities in terms of asthma self-management; "4" Conduct quantitative and qualitative data analysis; and "5" Disseminate the findings to larger audiences, key-informants, knowledge users and policy makers across BC. This research will make theoretical, methodological and applied research contributions. It will establish strong community - academic connections for the development of the proposed framework. Community participation will be applied throughout the development of this study and educational materials, enhancing the potential of acquiring new knowledge about cultural and traditional practices of the sample population.
The investigators' approach will allow health care workers and policy makers to design appropriate health promotion initiatives targeted to diverse newcomer groups in relation to asthma. The investigators foresee findings that provide not only better ways to measure health literacy pertaining to asthma in the investigators' target groups, but that will also help develop materials and measures that can be applied to diverse cultural populations in BC and the rest of Canada. The investigators expect that the participatory approach used in this study will contribute to capacity building, improving newcomers' ability to access and use relevant asthma information (in terms of prevention, control and management) and to transfer and share the information learned with other members of the target communities. The proposed community consultation will also help the investigators to identify culturally appropriate communication mode(s) to deliver health promotion messages and determine practical adult learning approaches applicable to diverse communities in Canada.
- Conditions
- Asthma
- Being tested
- patient role played community video, both videos group, Pamphlet group, physician-led knowledge video, Community video group
- Keywords
- Asthma, Community-based participatory research, Educational intervention, Ethno-cultural community, Video recording, Patient education handout
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient role played community videoBehavioural
Group two viewed the patient role played community video
both videos groupBehavioural
Group three viewed both the knowledge and community videos
Pamphlet groupBehavioural
Group four read an educational pamphlet only
physician-led knowledge videoBehavioural
Group one viewed a physician-led knowledge video
Community video groupBehavioural
Group two viewed the patient role played community video
knowledge videoBehavioural
Group one viewed a physician-led knowledge video
| Study group | Role | What they receive |
|---|---|---|
| Group 2: community video group | Experimental | In each community intervention group two subject viewed the patient role played community video Receives: Behavioral: patient role played community video; Behavioral: Community video group |
| Group three: both videos group | Experimental | In each community intervention group three subject viewed two videos (the patient role played community and physician-led knowledge videos) Receives: Behavioral: both videos group |
| Group four: pamphlet group | Active comparator | In each community intervention group four subject read an educational pamphlet only - act as active comparator group Receives: Behavioral: Pamphlet group |
| Group one: knowledge video group | Experimental | In each community intervention group one subject viewed the physician-led knowledge video Receives: Behavioral: physician-led knowledge video; Behavioral: knowledge video |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication adherence
Patients' understanding of physicians' instructions on how to follow their treatment regimen and regular use of inhalers were measured
Measured: on year
Secondary outcomes (2)
Patients' beliefs, perceptions, and attitudes toward asthma self-management
The investigators aimed to explore both broad and specific issues and concerns about asthma and its management of the patients from the target communities
Measured: 6 months
Educational materials and measurement tools development
The investigators involved end-users (i.e. asthma patients, their family members, and community key-informants) in developing linguistically and culturally appropriate education materials (e.g., video clips and pictorial pamphlets) and measurement tools, and conducted community events and forums.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startAug 2009
- Primary completionOct 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health, Ministry of Health, British Columbia, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Mark Fitzgerald, University of British Columbia
- Investigators
- Mark J FitzGerald, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474928
- Sponsor's protocol ID
- H08-02861
- Other IDs
- 187972
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2011
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poureslami I, Rootman I, Doyle-Waters MM, Nimmon L, Fitzgerald JM. Health literacy, language, and ethnicity-related factors in newcomer asthma patients to Canada: a qualitative study. J Immigr Minor Health. 2011 Apr;13(2):315-22. doi: 10.1007/s10903-010-9405-x.
PubMed 20938742Poureslami I, Shum J, Nimmon L, FitzGerald JM. Evaluating effect of culturally-specific educational interventions on asthma subjects' inhaler use technique and their understanding of physician instructions. Respiratory care, 2016
Poureslami I, Tregobov N, Shum J, McMillan A, Akhtar A, Kassay S, Starnes K, Mahjoob M, FitzGerald JM. A conceptual model of functional health literacy to improve chronic airway disease outcomes. BMC Public Health. 2021 Jan 30;21(1):252. doi: 10.1186/s12889-021-10313-x.
PubMed 33516200Poureslami I, Shum J, Nimmon L, FitzGerald JM. Culturally Specific Evaluation of Inhaler Techniques in Asthma. Respir Care. 2016 Dec;61(12):1588-1596. doi: 10.4187/respcare.04853. Epub 2016 Nov 8.
PubMed 27827331Poureslami I, Nimmon L, Doyle-Waters M, Rootman I, Schulzer M, Kuramoto L, FitzGerald JM. Effectiveness of educational interventions on asthma self-management in Punjabi and Chinese asthma patients: a randomized controlled trial. J Asthma. 2012 Jun;49(5):542-51. doi: 10.3109/02770903.2012.682125.
PubMed 22715910
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma and Health Literacy in Newcomer Communities in the Greater Vancouver Area (GVA): A Population-based Qualitative Study
- ClinicalTrials.gov ID
- NCT01474928
- Acronym / sponsor ID
- H08-02861
- Conditions
- Asthma
- Keywords
- Asthma, Community-based participatory research, Educational intervention, Ethno-cultural community, Video recording, Patient education handout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health, Ministry of Health, British Columbia, Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Nov 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.
In this study, the investigators aim to develop and test the effectiveness of culturally appropriate asthma videos and other educational materials based on knowledge from this study and the investigators' previous studies. By culturally appropriate materials the investigators mean to develop health information (in the format of video and written materials) in the community own language and applied the most appealing cultural beliefs and practices in the Chinese and Punjabi communities. The investigators also aim to recommend a practical framework and to develop a measure of asthma knowledge and health literacy among immigrants from the Punjabi and Chinese communities in BC. The investigators' definition of health literacy in this study is the capability of a person to navigate and access to asthma-related information, as well as to understand, evaluate, and communicate the obtained information to improve his/her health status. The investigators' hypothesis is that audio-visual based asthma information in a subject's native language would improve a patient's knowledge and self-management of asthma in comparison to printed information.
Detailed description
There is compelling evidence indicating that newcomers to Canada with limited English proficiency and low health literacy are facing systemic, linguistic and cultural barriers in accessing health information and treatment services pertaining to Asthma. The intent of this study is to develop and test the effectiveness of culturally appropriate asthma videos and other educational materials based on knowledge from this study and the investigators' previous elicitation studies, to recommend a practical framework and to develop a measure of asthma knowledge and health literacy among immigrants from the Punjabi and Chinese communities in the Greater Vancouver Area.
The objectives of the proposed research are: "1." to assess the knowledge, attitudes, beliefs, and practices related to asthma and relevant issues in selected individuals within the target communities; "2." to investigate access and utilization patterns of asthma-related services among participant communities; "3." to assess the effectiveness of culturally competent and participatory developed videos and written educational materials on individuals' knowledge and health literacy skills related to asthma; "4." to examine relationships between health literacy, culture, language and access to and utilization of asthma services among targeted newcomer individuals; "5." to build research capacity and community-university-service provider alliances, and contribute to the development of an integrated research-service agenda on newcomers' asthma self-management among target communities; and "6." to disseminate information to decision makers and knowledge-users , so the results of this study can be efficiently used in developing relevant services that meet newcomers' needs. The proposed research will use quantitative and qualitative methods including a full participatory approach that builds on the investigators' previous work with vulnerable ethno-cultural communities in BC.
The implementation of the project will include the following phases:
"1." Conduct environmental scan and needs assessment study (literature review and interviews); "2" Develop video clips, written materials, and relevant measurement tools; "3" Apply the video clips and written materials to test their effectiveness among individuals from the target communities in terms of asthma self-management; "4" Conduct quantitative and qualitative data analysis; and "5" Disseminate the findings to larger audiences, key-informants, knowledge users and policy makers across BC. This research will make theoretical, methodological and applied research contributions. It will establish strong community - academic connections for the development of the proposed framework. Community participation will be applied throughout the development of this study and educational materials, enhancing the potential of acquiring new knowledge about cultural and traditional practices of the sample population.
The investigators' approach will allow health care workers and policy makers to design appropriate health promotion initiatives targeted to diverse newcomer groups in relation to asthma. The investigators foresee findings that provide not only better ways to measure health literacy pertaining to asthma in the investigators' target groups, but that will also help develop materials and measures that can be applied to diverse cultural populations in BC and the rest of Canada. The investigators expect that the participatory approach used in this study will contribute to capacity building, improving newcomers' ability to access and use relevant asthma information (in terms of prevention, control and management) and to transfer and share the information learned with other members of the target communities. The proposed community consultation will also help the investigators to identify culturally appropriate communication mode(s) to deliver health promotion messages and determine practical adult learning approaches applicable to diverse communities in Canada.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 2: community video group | Experimental | Behavioral: patient role played community video, Behavioral: Community video groupIn each community intervention group two subject viewed the patient role played community video |
| Group three: both videos group | Experimental | Behavioral: both videos groupIn each community intervention group three subject viewed two videos (the patient role played community and physician-led knowledge videos) |
| Group four: pamphlet group | Active comparator | Behavioral: Pamphlet groupIn each community intervention group four subject read an educational pamphlet only - act as active comparator group |
| Group one: knowledge video group | Experimental | Behavioral: physician-led knowledge video, Behavioral: knowledge videoIn each community intervention group one subject viewed the physician-led knowledge video |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Physician diagnosed mild to moderate asthma according to CTS criteria
- Asthmatics from Chinese and Punjabi communities in the Greater Vancouver Area (GVA), BC
- Age greater than 21 years
- Immigrated to Canada in the last 10 yrs
- Patients who are able to give informed consent and are willing to participate in the study
Key exclusion criteria (4 listed)
- Age less than 21 years
- Other immigrants than Punjabi and Chinese
- Immigrated before 1998
- Patients who do not want to sign the consent form
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 |
|---|---|---|
| patient role played community videoGroup two viewed the patient role played community video | Behavioural | Group 2: community video group |
| both videos groupGroup three viewed both the knowledge and community videos | Behavioural | Group three: both videos group |
| Pamphlet groupGroup four read an educational pamphlet only | Behavioural | Group four: pamphlet group |
| physician-led knowledge videoGroup one viewed a physician-led knowledge video | Behavioural | Group one: knowledge video group |
| Community video groupGroup two viewed the patient role played community video | Behavioural | Group 2: community video group |
| knowledge videoGroup one viewed a physician-led knowledge video | Behavioural | Group one: knowledge video group |
Primary outcome
medication adherence
Time frame: on year
Patients' understanding of physicians' instructions on how to follow their treatment regimen and regular use of inhalers were measured
2 secondary outcomes
Patients' beliefs, perceptions, and attitudes toward asthma self-management
Time frame: 6 months
Educational materials and measurement tools development
Time frame: 3 months
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 28 Nov 2017.
- Results publication: PubMed 20938742Poureslami I, Rootman I, Doyle-Waters MM, Nimmon L, Fitzgerald JM. Health literacy, language, and ethnicity-related factors in newcomer asthma patients to Canada: a qualitative study. J Immigr Minor Health. 2011 Apr;13(2):315-22. doi: 10.1007/s10903-010-9405-x.
- Results publicationPoureslami I, Shum J, Nimmon L, FitzGerald JM. Evaluating effect of culturally-specific educational interventions on asthma subjects' inhaler use technique and their understanding of physician instructions. Respiratory care, 2016
- Derived from this study: PubMed 33516200Poureslami I, Tregobov N, Shum J, McMillan A, Akhtar A, Kassay S, Starnes K, Mahjoob M, FitzGerald JM. A conceptual model of functional health literacy to improve chronic airway disease outcomes. BMC Public Health. 2021 Jan 30;21(1):252. doi: 10.1186/s12889-021-10313-x.
- Derived from this study: PubMed 27827331Poureslami I, Shum J, Nimmon L, FitzGerald JM. Culturally Specific Evaluation of Inhaler Techniques in Asthma. Respir Care. 2016 Dec;61(12):1588-1596. doi: 10.4187/respcare.04853. Epub 2016 Nov 8.
- Derived from this study: PubMed 22715910Poureslami I, Nimmon L, Doyle-Waters M, Rootman I, Schulzer M, Kuramoto L, FitzGerald JM. Effectiveness of educational interventions on asthma self-management in Punjabi and Chinese asthma patients: a randomized controlled trial. J Asthma. 2012 Jun;49(5):542-51. doi: 10.3109/02770903.2012.682125.
- British Columbia Centre for Lung HealthLink provided by the sponsor.
- The Lung Centre at University of British ColumbiaLink provided by the sponsor.
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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.
Mark J FitzGerald, MD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient role played community video, both videos group and Pamphlet group in people with Asthma, run by University of British Columbia at 2 sites in Canada.
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 5 inclusion and 4 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 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
medication adherence (time frame: on year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01474928, which also lists 5 linked publications.
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 28 Nov 2017.