GIOP Prevention Among People With Rheumatoid Arthritis
June 12, 2015 updated by: University of North Carolina, Chapel Hill
Osteoporosis Prevention Among People With Rheumatoid Arthritis Receiving Oral Glucocorticoid Therapy
The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with rheumatoid arthritis by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims.
Specific Aim 1: To obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention.
Specific Aim 2: To identify factors that discriminate among patients in different stages of change with respect to each behavior of interest.
Specific Aim 3: To compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention of Glucocorticoid-Induced Osteoporosis.
Specific Aim 4: To determine if the effects of tailored educational materials are enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians.
Study Overview
Status
Completed
Conditions
Detailed Description
Therapy with oral glucocorticoids often plays an important role in the management of rheumatoid arthritis (RA).
The American College of Rheumatology (ACR) Ad Hoc Committee on Clinical Guidelines recently concluded that glucocorticoids are highly effective in relieving symptoms among people with active RA and that these medications may retard the rate of joint damage.
Despite these obvious benefits, therapy with oral glucocorticoids is a well-established risk factor for osteoporosis, as highlighted by the recently published ACR Guidelines on the Prevention of Glucocorticoid-induced Osteoporosis.
The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with RA by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy.
The study has four specific aims: (1) to obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention; (2) to identify factors that discriminate among patients in different stages of change with respect to each behavior of interest; (3) to compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention Glucocorticoid-induced Osteoporosis; and (4) to determine if the effects of tailored educational materials is enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians.
A sample of 273 patients with RA currently taking an oral glucocorticoid were recruited to participate in the study.
Data were collected via mailed questionnaires and telephone interviews.
The study used an experimental research design.
Following baseline data collection, participants were randomly assigned to one of four experimental groups.
Patients in one group received standard care only.
Patients in the second group received generic educational materials about osteoporosis and osteoporosis prevention in addition to standard care.
Patients in the third group received educational materials tailored to their stage in the behavior change process in addition to standard care.
Finally, patients in the fourth group received the same tailored educational materials and care received by patients in the third group.
In addition, each patient's physician received feedback concerning the patient's status with respect to behavioral risk factors for osteoporosis (e.g., inadequate calcium intake).
Follow-up data were collected one year after baseline data collection.
Variables assessed included: (1) behavior, (2) stage of change, (3) knowledge and counseling received concerning osteoporosis, (4) health beliefs, (5) physical health status, (6) osteoporosis risk factors, (7) background characteristics, and (8) information seeking.
To accomplish the specific aims of the study, data will be analyzed using descriptive statistics, multivariate analysis of variance, and discriminant analyses.
Study Type
Interventional
Enrollment (Actual)
273
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7360
- University of North Carolina at Chapel Hill School of Pharmacy
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meet American College of Rheumatology criteria for rheumatoid arthritis
- Taking an oral glucocorticoid equivalent to 5 mg/day of prednisone for at least one month prior to study entry
- Age 18 or older
Exclusion Criteria:
- Existing osteoporosis
- Pregnancy
- Breast feeding
- History of breast cancer
- Physician recommendation to limit calcium intake
- Class IV rheumatoid arthritis
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tailored Materials
|
Participants received written educational materials concerning each behavior targeted.
The materials were tailored to the participants' stage of change with respect to each behavior.
|
|
Experimental: Physician Feedback
|
Participants received written educational materials concerning each behavior targeted.
The materials were tailored to the participant's stage of change with respect to each behavior.
In additon, the participant's physician received information concerning the participant's status on each behavior targeted.
|
|
Active Comparator: Generic Materials
|
Participants received generic written educational materials about osteoporosis prevention.
|
|
Placebo Comparator: Placebo Comparator
Participants receive no information
|
Participants received no informational materials.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Calcium Intake
Time Frame: One Year
|
One Year
|
|
Vitamin D Intake
Time Frame: One Year
|
One Year
|
|
Bone Mineral Density Testing
Time Frame: One Year
|
One Year
|
|
Use of prophylactic medications (e.g., bisphosphonates)
Time Frame: One Year
|
One Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan J. Blalock, PhD, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
July 1, 2001
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
January 24, 2008
First Submitted That Met QC Criteria
January 24, 2008
First Posted (Estimate)
February 7, 2008
Study Record Updates
Last Update Posted (Estimate)
June 16, 2015
Last Update Submitted That Met QC Criteria
June 12, 2015
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Arthritis Foundation
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