GIOP Prevention Among People With Rheumatoid Arthritis
Primary Purpose
Osteoporosis, Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Materials
Tailored Materials Plus Physician Feedback
Generic Materials
No Information
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Glucocorticoids, Osteoporosis, Rheumatoid Arthritis, Prevention, GIOP, Patient Education
Eligibility Criteria
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
Sites / Locations
- University of North Carolina at Chapel Hill School of Pharmacy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Tailored Materials
Physician Feedback
Generic Materials
Placebo Comparator
Arm Description
Participants receive no information
Outcomes
Primary Outcome Measures
Calcium Intake
Vitamin D Intake
Bone Mineral Density Testing
Use of prophylactic medications (e.g., bisphosphonates)
Secondary Outcome Measures
Full Information
NCT ID
NCT00609830
First Posted
January 24, 2008
Last Updated
June 12, 2015
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT00609830
Brief Title
GIOP Prevention Among People With Rheumatoid Arthritis
Official Title
Osteoporosis Prevention Among People With Rheumatoid Arthritis Receiving Oral Glucocorticoid Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Rheumatoid Arthritis
Keywords
Glucocorticoids, Osteoporosis, Rheumatoid Arthritis, Prevention, GIOP, Patient Education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tailored Materials
Arm Type
Experimental
Arm Title
Physician Feedback
Arm Type
Experimental
Arm Title
Generic Materials
Arm Type
Active Comparator
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Participants receive no information
Intervention Type
Behavioral
Intervention Name(s)
Tailored Materials
Intervention Description
Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participants' stage of change with respect to each behavior.
Intervention Type
Behavioral
Intervention Name(s)
Tailored Materials Plus Physician Feedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Generic Materials
Intervention Description
Participants received generic written educational materials about osteoporosis prevention.
Intervention Type
Behavioral
Intervention Name(s)
No Information
Intervention Description
Participants received no informational materials.
Primary Outcome Measure Information:
Title
Calcium Intake
Time Frame
One Year
Title
Vitamin D Intake
Time Frame
One Year
Title
Bone Mineral Density Testing
Time Frame
One Year
Title
Use of prophylactic medications (e.g., bisphosphonates)
Time Frame
One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J. Blalock, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill School of Pharmacy
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7360
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16208664
Citation
Blalock SJ, Norton LL, Patel RA, Dooley MA. Patient knowledge, beliefs, and behavior concerning the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheum. 2005 Oct 15;53(5):732-9. doi: 10.1002/art.21446.
Results Reference
result
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GIOP Prevention Among People With Rheumatoid Arthritis
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