Chronic Obstructive Pulmonary Disease (COPD)COPDNCT01474707
Educational Interventions for Chronic Obstructive Pulmonary Disease (COPD) Self-management in Ethno-cultural Communities
A study testing Group one, Group two and Group three in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of British Columbia at 2 sites in Canada.
Trial summary
Goal: The main goal of this study is to develop and validate educational materials that aim to improve self-management knowledge and practices about COPD among patients in Mandarin and Cantonese-speaking communities in the Greater Vancouver Area (GVA). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Group one, Group two and Group three
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2011to Jan 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A physician diagnosed COPD patients
- Be at least 21 years old
- Speaks Mandarin or Cantonese
- Immigrated to Canada in the past 15 years from mainland China or Hong Kong
Who cannot join
- Self-reported patients
- Person under 21 years old
- Person who lives in a nursing home
- Unwilling to participate in the study
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 Coastal Health
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Assessing Chronic Obstructive Pulmonary Disease (COPD) Knowledge, Beliefs, and Health Literacy in Chinese Immigrant Adults With a Diagnosis of COPD
Goal: The main goal of this study is to develop and validate educational materials that aim to improve self-management knowledge and practices about COPD among patients in Mandarin and Cantonese-speaking communities in the Greater Vancouver Area (GVA).
Objectives: "1." To assess the current landscape of COPD beliefs, perceptions and practices, as well as health literacy as it relates to Chinese Mandarin and Cantonese-speaking patients; "2." To develop effective partnerships within primary care physicians serving Chinese newcomers in the GVA' "3." To conduct focus group sessions with collaborative primary care physicians to identify common factors that contribute to under service and access barriers among patients in the target communities; "4." To assess the effectiveness of the educational materials on patients' beliefs, perceptions, practices, and health literacy related to COPD control and self-management; and "5." To improve the capacity of physicians and allied health workers in primary care settings in educating patients and their families about self-management of COPD.
The implementation of the project will include the following phases: "1." Build and strengthen established partnerships with primary care practices serving newcomers in GVA; "2." Conduct an environmental scan and needs assessment (literature review, interviews and focus groups with community members and key-informants); "3." Development of story scripts, video clips and other educational materials, and relevant measurement tools; "4." Application of the video clips and other educational materials to test their effectiveness on health literacy, beliefs, and knowledge among COPD patients from the target communities; and "5." Evaluation of the usefulness of videos and other educational materials, and the project's process and outcomes.
Read the detailed description
The main aim of this project is to address our knowledge gap about COPD management, access problems, and differences in environmental exposure among newcomers in Canada: by engaging key stakeholders, fostering dialogue, gathering baseline data, and generating knowledge on how improved access to culturally and linguistically appropriate educational materials can enhance awareness and practices about COPD control and self-management through interventional study, thereby improving the health status of the target populations. We plan to document: "1." what are the cultural imperatives that are likely to mediate ethnic Chinese patients to manage COPD? "2." to what extent does the Canadian health care system's environment influence newcomers response to COPD? Our aim is to examine the belief system and health practices among target communities that may influence treatment and management of COPD.
This research will make theoretical, methodological and applied research contributions. It will establish strong community - primary care provider and academic connections for the development of the proposed educational materials, measurement tools, and framework. Community participation will be included throughout the development of this study, enhancing the potential of acquiring new knowledge about cultural and traditional practices of the sample population.
Our approach will enable primary health care providers, knowledge users, and policy makers to design appropriate educational intervention initiatives targeted to diverse ethnic minority groups in relation to COPD. We foresee findings that provide not only better ways to measure health literacy pertaining to COPD in our target populations, but that will also help develop materials and measures that can be applied to other populations in BC and the rest of Canada. We expect that the participatory approach used in this study will contribute to capacity building, improving newcomers' ability to access and use relevant COPD 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 us identify culturally appropriate communication mode(s) to deliver health information messages and determine practical adult learning approaches applicable to diverse communities in Canada.
- Being tested
- Group one, Group two, Group three, Group four
- Keywords
- COPD, Educational materials, Cultural background, Instructional videos, Patient education handouts, Lung age
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group oneBehavioural
Group 1 will view the knowledge-based video only
Group twoBehavioural
Group two will view the motivational video only
Group threeBehavioural
Group three will view both knowledge-based and motivational videos
Group fourBehavioural
Group four will view the printed educational pamphlet and will not view either video
| Study group | Role | What they receive |
|---|---|---|
| Group one | Experimental | Group1 will view the knowledge-based video only Receives: Behavioral: Group one |
| Group two | Experimental | Group two will view the motivational video only Receives: Behavioral: Group two |
| Group three | Experimental | Group three will view both knowledge-based and motivational videos Receives: Behavioral: Group three |
| Group four | Experimental | Group four will view the printed educational pamphlet and will not view either video Receives: Behavioral: Group four |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using study questionnaire to measure knowledge about COPD control and self-management
The investigators will assess participants knowledge about COPD management and control at initial visit (baseline), and will then assess it again two more times: at month two (post-test) and month six (follow-up post-test). The investigators will then compare the changes in the participants' knowledge within this six-month period; from initial visit to follow-up post-test.
Measured: Six months
Secondary outcomes (2)
Assessing the target community cultural beliefs and practices and systemic barriers that are likely interfere Chinese patients to manage their COPD
The investigators will conduct two focus group sessions (one in Mandarin and one in Cantonese) with Chinese key-informants, COPD patients, primary care partners, and members of the study Community Advisory Committee to discuss and brainstorm about the cultural, language, and systemic barriers that prevent patient from Chinese community to self-manage their COPD.
Measured: Four months
Educational materials development
The investigators will develop educational materials for this study (including video clips and patient handouts) through a participatory action approach with direct involvement of Chinese key informants, media people, study collaborators, and community members. The investigators will develop two motivational and two knowledge-based videos, as well as two pictorial pamphlets.
Measured: Four 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 startJan 2011
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health, Main Line Health, Provincial Health Services Authority British Columbia, Vancouver Foundation, Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Mark Fitzgerald, University of British Columbia
- Investigators
- Mark J FitzGerald, M.D., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474707
- Sponsor's protocol ID
- H09-02069
- Acronym
- COPD
- Status last verified
- Nov 2017
- First submitted
- 3 Nov 2011
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poureslami I, Kwan S, Lam S, Khan NA, FitzGerald JM. Assessing the effect of culturally specific audiovisual educational interventions on attaining self-management skills for chronic obstructive pulmonary disease in Mandarin- and Cantonese-speaking patients: a randomized controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Aug 3;11:1811-22. doi: 10.2147/COPD.S105408. eCollection 2016.
PubMed 27536093
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
- Assessing Chronic Obstructive Pulmonary Disease (COPD) Knowledge, Beliefs, and Health Literacy in Chinese Immigrant Adults With a Diagnosis of COPD
- ClinicalTrials.gov ID
- NCT01474707
- Acronym / sponsor ID
- COPD / H09-02069
- Keywords
- COPD, Educational materials, Cultural background, Instructional videos, Patient education handouts, Lung age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health, Main Line Health, Provincial Health Services Authority British Columbia, Vancouver Foundation, Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (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.
Goal: The main goal of this study is to develop and validate educational materials that aim to improve self-management knowledge and practices about COPD among patients in Mandarin and Cantonese-speaking communities in the Greater Vancouver Area (GVA).
Objectives: "1." To assess the current landscape of COPD beliefs, perceptions and practices, as well as health literacy as it relates to Chinese Mandarin and Cantonese-speaking patients; "2." To develop effective partnerships within primary care physicians serving Chinese newcomers in the GVA' "3." To conduct focus group sessions with collaborative primary care physicians to identify common factors that contribute to under service and access barriers among patients in the target communities; "4." To assess the effectiveness of the educational materials on patients' beliefs, perceptions, practices, and health literacy related to COPD control and self-management; and "5." To improve the capacity of physicians and allied health workers in primary care settings in educating patients and their families about self-management of COPD.
The implementation of the project will include the following phases: "1." Build and strengthen established partnerships with primary care practices serving newcomers in GVA; "2." Conduct an environmental scan and needs assessment (literature review, interviews and focus groups with community members and key-informants); "3." Development of story scripts, video clips and other educational materials, and relevant measurement tools; "4." Application of the video clips and other educational materials to test their effectiveness on health literacy, beliefs, and knowledge among COPD patients from the target communities; and "5." Evaluation of the usefulness of videos and other educational materials, and the project's process and outcomes.
Detailed description
The main aim of this project is to address our knowledge gap about COPD management, access problems, and differences in environmental exposure among newcomers in Canada: by engaging key stakeholders, fostering dialogue, gathering baseline data, and generating knowledge on how improved access to culturally and linguistically appropriate educational materials can enhance awareness and practices about COPD control and self-management through interventional study, thereby improving the health status of the target populations. We plan to document: "1." what are the cultural imperatives that are likely to mediate ethnic Chinese patients to manage COPD? "2." to what extent does the Canadian health care system's environment influence newcomers response to COPD? Our aim is to examine the belief system and health practices among target communities that may influence treatment and management of COPD.
This research will make theoretical, methodological and applied research contributions. It will establish strong community - primary care provider and academic connections for the development of the proposed educational materials, measurement tools, and framework. Community participation will be included throughout the development of this study, enhancing the potential of acquiring new knowledge about cultural and traditional practices of the sample population.
Our approach will enable primary health care providers, knowledge users, and policy makers to design appropriate educational intervention initiatives targeted to diverse ethnic minority groups in relation to COPD. We foresee findings that provide not only better ways to measure health literacy pertaining to COPD in our target populations, but that will also help develop materials and measures that can be applied to other populations in BC and the rest of Canada. We expect that the participatory approach used in this study will contribute to capacity building, improving newcomers' ability to access and use relevant COPD 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 us identify culturally appropriate communication mode(s) to deliver health information 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 one | Experimental | Behavioral: Group oneGroup1 will view the knowledge-based video only |
| Group two | Experimental | Behavioral: Group twoGroup two will view the motivational video only |
| Group three | Experimental | Behavioral: Group threeGroup three will view both knowledge-based and motivational videos |
| Group four | Experimental | Behavioral: Group fourGroup four will view the printed educational pamphlet and will not view either video |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A physician diagnosed COPD patients
- Be at least 21 years old
- Speaks Mandarin or Cantonese
- Immigrated to Canada in the past 15 years from mainland China or Hong Kong
Key exclusion criteria (4 listed)
- Self-reported patients
- Person under 21 years old
- Person who lives in a nursing home
- Unwilling to participate 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 |
|---|---|---|
| Group oneGroup 1 will view the knowledge-based video only | Behavioural | Group one |
| Group twoGroup two will view the motivational video only | Behavioural | Group two |
| Group threeGroup three will view both knowledge-based and motivational videos | Behavioural | Group three |
| Group fourGroup four will view the printed educational pamphlet and will not view either video | Behavioural | Group four |
Primary outcome
Using study questionnaire to measure knowledge about COPD control and self-management
Time frame: Six months
The investigators will assess participants knowledge about COPD management and control at initial visit (baseline), and will then assess it again two more times: at month two (post-test) and month six (follow-up post-test). The investigators will then compare the changes in the participants' knowledge within this six-month period; from initial visit to follow-up post-test.
2 secondary outcomes
Assessing the target community cultural beliefs and practices and systemic barriers that are likely interfere Chinese patients to manage their COPD
Time frame: Four months
Educational materials development
Time frame: Four 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 27536093Poureslami I, Kwan S, Lam S, Khan NA, FitzGerald JM. Assessing the effect of culturally specific audiovisual educational interventions on attaining self-management skills for chronic obstructive pulmonary disease in Mandarin- and Cantonese-speaking patients: a randomized controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Aug 3;11:1811-22. doi: 10.2147/COPD.S105408. eCollection 2016.
- UBC Lung CentreLink 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, M.D. 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 Group one, Group two and Group three in people with Chronic Obstructive Pulmonary Disease (COPD), 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 4 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?
Using study questionnaire to measure knowledge about COPD control and self-management (time frame: Six months). 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 NCT01474707, which also lists 1 linked publication.
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.