Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00832676 |
| Other study ID # |
DOCH2 447-2008 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 26, 2009 |
| Last updated |
January 6, 2011 |
| Start date |
January 2009 |
| Est. completion date |
December 2009 |
Study information
| Verified date |
January 2011 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Ethics Review Committee |
| Study type |
Observational
|
Clinical Trial Summary
Inflammatory arthritis (IA) is a major cause of long-term disability. Due to specialist
shortages, failure of primary care providers and individuals to recognize the disease, and
lack of awareness of the importance of early intervention, delays to rheumatologic care are
common. Peer support models have been used for various health issues and may be one method
to assist individuals with early IA to manage their disease and cope with stress.
Qualitative research methods (focus groups) will seek out feedback on a peer support
approach and explore the learning needs (informational needs, educational preferences) and
opinions about emotional and appraisal support of individuals living with IA, from the
perspectives of patients. The data will be analyzed and expressed themes (articulated needs
and understandings of interviewee context) will guide the future development of a peer
support intervention.
Description:
RESEARCH PROTOCOL
____________________________________________________________________
Exploring the Learning Needs of Individuals with Inflammatory Arthritis from the
Perspectives of Patients, Family Members and Friends, and Health Care Providers: Patient
Perspectives
_____________________________________________________________________
RATIONALE
Rheumatic diseases are a chronic, lifelong illness that results in significant pain,
disability, and morbidity in the Canadian population (Perruccio, Power & Badley, 2006).
Focusing on one aspect of rheumatic diseases, inflammatory arthritis has been associated not
only with the aforementioned concerns, but also with an increased burden of care that
affects not only patients, but extends its impact to include their family members, friends,
and caregivers. Inflammatory arthritis is also associated with significant increases to
healthcare budgets (Hunsche, Chancellor & Bruce, 2001). Care and management of these
diseases are expected to be in high demand as the burden of illness is estimated to be on
the rise (Perruccio, Power & Badley, 2006). The number of primary care providers and
specialists is not sufficient to meet this anticipated increase, (Beaulieu et al., 2004;
Glazier et al., 2003) and patients dealing with chronic diseases are increasingly required
to self-manage their disease. This can be a stressful and daunting process for a newly
diagnosed patient and may result in delayed decision-making and ultimately, delays in their
disease treatment.
While physician care is undeniably important in the management of inflammatory arthritis,
educating patients with the knowledge and skills to self-manage their disease can be helpful
with decision-making processes and reducing healthcare burden. For example, Lorig et al
(2001) demonstrated that individuals who were better able to self-manage their illness
experienced a significant improvement in health behaviours, self-efficacy, and health
status, and had fewer visits to emergency departments. By equipping patients with strategies
to cope and enhance personal health, they take on a more active role in the management of
their disease and are able to take on health promoting activities with little supervision
from healthcare professionals (Keysor et al., 2003). In fact, patient education in
self-management has been identified as an arthritis best-practice and a key clinical
practice guideline and (Combe et al., 2007; Holbrook, 2000; Jordan et al., 2003).
Patient education can take many forms, but peer support interventions have been particularly
effective in helping patients manage chronic diseases, including HIV, alcoholism and
diabetes. Likewise, we hope to examine the benefits, challenges, and impact peer support can
have on individuals living with inflammatory arthritis. A peer is someone who shares a
common characteristic, such as age, gender, social economic status, education, religion, or
in this case, status of disease (Doull et al., 2005). Peers have experiential knowledge of
rheumatic disease, its management and care, and the social implications it has had in their
lives. Within a healthcare context, they can provide assistance to individuals living with
arthritis by providing support to their emotional, appraisal, and informational needs. Peers
have the potential to influence health outcomes of other patients by addressing feelings of
isolation and loneliness, promoting positive outlook and motivation, and providing
information about behaviors that encourage health and well-being (Dennis, 2003). They can
augment the services provided by healthcare professionals and can help individuals with
inflammatory arthritis better cope and manage their illness. While peer support groups have
been used to address many chronic diseases, their implementation amongst individuals with
inflammatory arthritis has been limited. The effectiveness of such a program is dependent on
the educational preferences and learning needs of its participants and this is a topic that
requires examination and further assessment.
PURPOSE AND OBJECTIVE
This project addresses one subcomponent of a larger study in which the overall purpose is to
explore the learning needs (informational needs, emotional needs, and appraisal needs) and
the educational preferences of individuals with inflammatory arthritis. The impact of formal
or informal peer support on individuals with rheumatic disease and the improvement of their
health and well-being will also be examined with an emphasis on peer support from the
perspective of patients living with the disease.
This project will focus on soliciting perspectives of patients with inflammatory arthritis.
To better understand the learning needs and potential impact of peer support strategies,
including the context, circumstances, and processes involved in making peer support an
effective intervention. This project, in particular, will examine:
- the perspective of individuals with inflammatory arthritis regarding disease management
and educational needs
- what they feel are their emotional, informational, appraisal needs
- what specific feedback they are seeking related to peer support
- whether and how these needs change over the progression and duration of the disease
course
METHODOLOGY
Qualitative examination of the aforementioned objectives will be carried out using focus
groups.
Study Design
Eligible study participants will be divided into three focus groups of 6-8 participants each
based on their disease duration:
- 0-6 months
- Over 6 months - 2 years
- 2 - 5 years
Each focus group will be comprised of individuals with inflammatory disease of mixed age and
gender. Focus group sessions will be held over several weeks and at a time convenient to the
participants. This will be done in order to avoid conflicts with work and shift schedules.
Informed, written consent will also be obtained from potential participants (Appendix 1 -
Information Sheet and Appendix 2 - Consent Form).
Two second-year medical student co-investigators and/or the study coordinator from the
University of Toronto will be present at each focus group session. A semi-structured
interview guide will be used (Appendix 3 - Interview Guide) with probes to prompt further
discussion when appropriate. One medical student will conduct the focus group while the
second student or study coordinator will keep a speaker log and take notes throughout the
session. Each participant will be assigned a number and a record will be kept of the first
phrase of each speaker. The speaker log will be used to aid in the analysis (i.e. to clarify
if the view was expressed by a number of people or one person many times). During focus
group discussions, only the first name of each participant will be used.
Focus group sessions will run approximately 1 ½ - 2 hours in duration. After every session,
each medical student/study coordinator will create field notes in which they will
independently record their thoughts and impressions of the interview, non-verbal
communication, and other conversations not recorded before or after the meeting. Each focus
group session will also be recorded using a digital audio recorder and will be transcribed
in whole or in part. Transcribed names will be removed, instead being replaced by their
assigned speaker numbers.
Subjects
Potential focus group participants will have to meet all of the following criteria:
- Have a diagnosis of inflammatory arthritis from a physician
- Be able to participate in a 1 ½- 2 hour focus group session
- Be aged 18 years or older
- Be English-speaking
- Be able to get to the focus group session
Recruitment and Consent Potential research participants will be identified through the
Rheumatology clinics at the Sunnybrook Health Science Centre (SHSC). They will be approached
by Dr. Mary Bell (Principal Investigator), staff Rheumatologist, who will introduce the
study to eligible individuals and obtain their verbal consent to be contacted by the medical
student co-investigator assigned to the project. The name of the individual will then be
forwarded to the Office Manager who will schedule an interview at the Rheumatology clinic.
At the interview, medical students will go over an information letter on the study and a
consent form with each eligible patient to ensure that the potential research participant
understands the study and what he/she is being asked to do. Once written consent is
obtained, a copy will be provided to the participant. A confirmation letter (Appendix 4 -
Confirmation Letter to Research Participants) with time and location of the interview/focus
group will be mailed to the participant. The day before the interview is scheduled to take
place the medical student will telephone the individual to remind them of the time and
location of the interview using a Telephone Script (Appendix 5 - Telephone Script to Confirm
Interview). At the beginning of the interview, prior to asking any questions, the medical
student will obtain written consent and answer any further questions the participants may
have.
DATA ANALYSIS
Transcripts will be analyzed using content analysis in order to systematically make
inferences from text. Interview data will be imported into a NVIV0 8 qualitative software
package and analyzed using a constant comparative method by the two research team members
who were present at the focus group discussions. Medical students will be trained in
qualitative content analysis. Interview data will be categorized into themes by each team
member independently using an iterative coding scheme developed by the team. To ensure
consistency in coding, the research team members who completed the focus group will
frequently meet with the Principle Investigator and study coordinator to ensure consistency
in coding and to verify the credibility of the codes. New codes will be added as themes
arise from the data analysis. The individuals who conducted the focus group will
independently code transcripts and subsequently meet compare results of the coding and agree
upon their understanding of themes that emerged. By doing this cross-referencing, the rigor
of the study will be increased. Modifications will be made to the interview guide with
subsequent interviews to include new questions or probes that came up with prior focus group
discussions. Field notes will also be used to inform the analysis.
RISKS AND BENEFITS
There are no known risks that may be associated with this study. Participants may become
upset or emotional during the focus group session because the nature of the discussions will
require open, honest sharing. The research team will make available a list of support groups
and help-lines and reinforce that care of participants will not be affected in any way
should an individual decide to withdraw from the study.
These group discussions will benefit participants as they share and discover other
individuals who can relate to their disease experiences. Individuals with arthritis in
Ontario may indirectly benefit in the event that this research helps develop a peer support
intervention for individuals with inflammatory arthritis that may be implemented as part of
the patient care process. The results of this study may help validate the importance of
support based on experiential knowledge in decision-making, health promotion, and education
and may encourage the implementation of peer support groups among individuals living with
inflammatory arthritis.
PRIVACY AND CONFIDENTIALITY
Only the Principal Investigator, Office Manager and the medical students/study coordinator
who conduct the focus group sessions will be aware of the identity of participants. All data
collection forms will have identifying information removed and replaced with a unique
identifying number. A list of participant names, addresses, and phone numbers will be kept
on a password protected computer on a secure server in a locked research room at the
rheumatology clinic at Sunnybrook Health Sciences Centre to be accessed only by the
Principle Investigator and research team involved in this study. Names or other identifying
information will not be used in any publications, reports, or presentations and will not be
passed on to anyone else outside of the research team for this study. All information
collected during the focus group sessions will be kept confidential. Hard copies of data and
will be locked in a research room at Sunnybrook Health Sciences Centre for storage for 25
years before being destroyed. All electronic data files (i.e., audiofiles, transcripts) will
be stored on a password protected computer on a secure server in a locked office at the
Sunnybrook Health Sciences Centre rheumatology clinic. A confidentiality agreement will be
signed by the study coordinator and all second year medical students involved with the
study.
COMMUNICATION OF RESULTS
In terms of reporting study results, a written report will be created and sent to any
participants involved in the study upon their request. A copy will also be submitted to the
University of Toronto DOCH-2 Course Coordinator and the results of this study may also be
shared with scientific publications, conferences, and presentations.
TEAM
Principal Investigator Mary J Bell
Co-Investigators Joyce Nyhof Young Romy Cho Chris Tran Lopamudra Das Phedias Diamandis Paula
Veinot
Study Coordinator Paula Veinot
Research Assistant Gaya Embuldeniya
