Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Educational Interventions for Chronic Obstructive Pulmonary Disease (COPD) Self-management in Ethno-cultural Communities

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Vancouver Coastal Health
Main Line Health
Provincial Health Services Authority
Vancouver Foundation
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01474707
First received: November 3, 2011
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Behavioral: Group one
Behavioral: Group two
Behavioral: Group three
Behavioral: Group four

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Assessing Chronic Obstructive Pulmonary Disease (COPD) Knowledge, Beliefs, and Health Literacy in Chinese Immigrant Adults With a Diagnosis of COPD

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Using study questionnaire to measure knowledge about COPD control and self-management [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Educational materials development [ Time Frame: Four months ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group one
Group1 will view the knowledge-based video only
Behavioral: Group one
Group 1 will view the knowledge-based video only
Experimental: Group two
Group two will view the motivational video only
Behavioral: Group two
Group two will view the motivational video only
Experimental: Group three
Group three will view both knowledge-based and motivational videos
Behavioral: Group three
Group three will view both knowledge-based and motivational videos
Experimental: Group four
Group four will view the printed educational pamphlet and will not view either video
Behavioral: Group four
Group four will view the printed educational pamphlet and will not view either video

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Self-reported patients
  • Person under 21 years old
  • Person who lives in a nursing home
  • Unwilling to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474707

Locations
Canada, British Columbia
University of British Columbia - Vancouver Coastal Health
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health
Main Line Health
Provincial Health Services Authority
Vancouver Foundation
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Mark J FitzGerald, M.D. University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01474707     History of Changes
Other Study ID Numbers: H09-02069
Study First Received: November 3, 2011
Last Updated: December 23, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
COPD
Educational materials
Cultural background
Instructional videos
Patient education handouts
Lung age

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014